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View Temad`s portfolio of Narcotic & Non-Narcotic APIs, Intermediates & Finished Products & explore Temad`s manufacturing activities on PharmaCompass.
View Temad's portfolio of Narcotic & Non-Narcotic APIs, Intermediates & Finished Products & explore Temad's manufacturing activities on PharmaCompass.What are Narcotic APIs?Narcotic API is an active substance which produces analgesia and narcosis (state of sleep). These APIs also provide addiction (physical dependance) and euphoria (pleasant effects) in certain people. Narcotics include various drugs, such as heroin, morphine, pethidine, etc., that cause numbness and stupor. In patients recovering from surgery or experiencing severe pain linked to cancer, narcotics are used to relieve moderate to severe pain, such as chronic headaches and backaches.The government regulates the production, possession, and usage of narcotics since they can be abused or cause addiction (physical dependence on the drug). The control extends to the way they are produced, used, handled, stored, and distributed.Narcotics are like opiates such as morphine and codeine, but are not made from opium. Opiates are compounds found in or derived from opium. Opium is made from the dried milky juice of the opium poppy (Papaver somniferum) seed pods.Natural opioids include opium and its derivatives, heroin, morphine, and codeine. Semi-synthetic opioids, such as hydrocodone, oxycodone, hydromorphone, oxymorphone, and buprenorphine, are partially derived from opium and codeine.Narcotics are attached to opioid receptors in the central nervous system (CNS). Apart from narcotics, controlled substances also include stimulants, depressants, hallucinogens, and anabolic steroids.Narcotic drugs are classified into five Schedules under the Controlled Substances Act (CSA) 1970, depending on their medical usefulness, misuse potential, safety, and drug dependence profile.What are the different challenges associated with manufacturing Narcotic APIs?The demand for narcotic APIs has increased in recent years, and so have the challenges. Specialized expertise is required to navigate the stringent regulations surrounding narcotic APIs. The International Narcotics Control Board (INCB) regulates the production, distribution, import, and export of narcotics to reduce the risk of illegal use.The various challenges associated with the manufacturing of narcotic APIs are listed below:Pharmaceutical companies must adhere to several security and laboratory controls, as well as very strict training with safety precautions, to ensure the safe handling of narcotic APIs throughout the manufacturing process.The manufacturing of narcotic materials necessitates specialized handling procedures for receiving, transferring, packaging, and shipping.For the production of narcotic APIs, R&D laboratory control measures such as equipment cleaning validations at extremely low levels, adequately isolated and cleaned facilities, dedicated laboratory equipment, and keycard security systems are necessary. Special documents, including records for receipt, use, inventory, and managing expired narcotics, are required for the development and manufacturing of narcotic APIs.Handling narcotics requires skilled and trained professionals who must follow highly regimented safety protocols and PPE requirements. These professionals should be experienced in handling and working with controlled substances and hazardous materials.As inadequate disposal leads to several detrimental health conditions, the manufacturing and disposal of narcotic APIs need to be carried out properly. Narcotic APIs require highly secure and controlled access to development and production suites, waste management systems and raw materials, as well as storage facilities.Temad is a pioneer in producing high-quality narcotic and non-narcotic APIs (Active Pharmaceutical Ingredients) and FDFs (Finished Dosage Forms) in compliance with international standards.What is Temad and what does it offer?Temad Co (Tolid Mavade Avallieh Daroupakhsh), is one of the companies of Tamin Pharmaceutical Investment Company (TPICO) from SSIC SHASTA Group. Established in 1997, it is one of the largest APIs (Active Pharmaceutical Ingredients) producers in Iran.Temad is an innovative manufacturer of narcotics and non-narcotic Active Pharmaceutical Ingredients (APIs) and semi-finished pellets in the Middle East. Temad started producing FDFs (Finished Dosage Forms) such as syrups, tablets, and capsules in 2017 with the aim of cornering a major share of the narcotics and non-narcotics market.Temad sells its Finished Dosage Forms to domestic pharmaceutical companies and the Middle East, and it also exports 23 products to 45 countries across 5 continents. As a result, Temad has a strong international presence and plays an important role in supplying pharmaceutical materials and narcotics to global markets.In 2017, Temad received license to produce FDFs (Finished Dosage Forms) in addition to the production of Active Pharmaceutical Ingredients (APIs), and began the production line of oral solutions (syrups). Today, Temad is licensed to produce methadone syrups and opium along with Guaicodin.Temad is a leader in the production of the highest-quality narcotic and non-narcotic APIs (Active Pharmaceutical Ingredients) and FDFs (Finished Dosage Forms). The quality management system in Temad ensures that the quality of the products meets the needs of the customer and the community in accordance with the requirements of GLP, GDP, GSP and GMP.Temad utilizes, maintains, and improves the integrated management system, including quality management systems ISO9001: 2015, environmental management systems ISO14001: 2015, ISO45001: 2018, and occupational health, safety, and environmental system OHSAS 18001: 2007.What are the different pharmaceutical products offered by Temad?Temad Co has 23 active production lines (12 lines at its Alborz site and 11 lines at its Mashhad site) and over 70 kinds of pharmaceutical products. The pharmaceutical products include narcotics, non-narcotics, LVHV, corton, injections, medicine for opioid dependency; Buprenorphine tablets (2 mg), Methadone tablets (20 and 40 mg), Methadone syrup, Opium syrup (1%), Guaicodin syrup and pellet products.These products are controlled and evaluated according to GMP and WHO standards, as well as other international standards like USP, BP, EP, IP, and JP.The various products offered by Temad are mentioned below:Narcotic APIs: Temad offers various narcotic APIs including Codeine, Noscapine, Methadone, Buprenorphine, Morphine, Opium Tincture 1% & 2%, Oxycodone, Oxymorphone, Pholcodine, Papaverine, Naltrexone, Naloxone, Paracetamol Powder/DC, and Hydrocodone.Finished Products: In 2017, Temad received a license to produce Finished Dosage Forms in addition to manufacturing APIs (Active Pharmaceutical Ingredients). It began work on the production line for oral solutions (syrup). Today, various oral dosage forms, such as Omeprazole 20 mg, Ciprofloxacin 500mg, Acetaminophen, Tramadol 100, etc. are produced by Temad.Semi-finished Products: Temad offers lansoprazole pellets (8.5%), omeprazole pellets (8.5%), pantoprazole sodium pellets (15% and 20%) and esomeprazole pellets (22.5%).Intermediates: Noroxymorphone powder is a best-selling pharmaceutical intermediate of Temad and is used for the treatment of pain and inflammation. Temad offers a total of 20 intermediates, including Norcodeine ethyl carbamate, Hydroxycodeinone, Normorphinone ethyl carbamate, 6-Acetyl dihydrocodeine, Thevinone, Norbuprenorphine, Thevinol, Buprenorphine base, etc.

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July, 2023
View Kewpie`s pharmaceutical grade Sodium hyaluronate & browse its different grades of Hyaluronic Acid for injectables & eye drops on PharmaCompass.
View Kewpie's pharmaceutical grade Sodium hyaluronate & browse its different grades of Hyaluronic Acid for injectables & eye drops on PharmaCompass.What is Sodium hyaluronate (Hyaluronic acid) and what are its properties?Sodium hyaluronate is the sodium salt of Hyaluronic acid (HA) which is a mucopolysaccharide made up of glucuronic acid and N-acetylglucosamine. Hyaluronic acid is distributed throughout the body, such as in the human skin (high concentrations are found in the epidermis/dermis), synovial fluid, and the vitreous body of the eyes.Hyaluronic acid is also known by several other names, such as HA, hyaluronan, hyaluronate, and Sodium hyaluronate. The molecular weight of Sodium hyaluronate is lower than the molecular weight of HA. It is, however, small enough to penetrate the epidermis, or top layer of skin, to improve hydration from the underlying skin layers, resulting in a greater hydrating effect.Hyaluronic acid is an elastoviscous fluid composed of hylan polymers, which are derivatives of hyaluronan, a naturally occurring complex sugar. The physiological functions of Hyaluronic acid include anti-aging, wound healing, protection against infection, and collagen fiber biosynthesis.The sources of Hyaluronic acid include bovine tracheas, bovine vitreous, rooster combs, and plants. Industrial production of Hyaluronic acid is based on either its extraction from animal tissues or large-scale lactic acid bacterial fermentation with genetically engineered strains. Plant-based HA is extracted from microbial fermentation in addition to animal-based Hyaluronic acid.A majority of the industries use Hyaluronic acid supplements for joint diseases, particularly inflammation. Sodium hyaluronate is used to alleviate knee pain in patients with osteoarthritis who have not found relief from other treatments. Hyaluronan is found in higher concentrations in synovial tissue and fluid, along with other soft connective tissues. Sodium hyaluronate also plays a key role in cell proliferation, cell migration, matrix assembly, and tissue development, and may also be involved in the advancement of some malignant tumors.Hyaluronic acid comes in five different sizes and molecular weights that permeate various layers of the skin. Because molecules with lower molecular weight are smaller, they can reach deeper layers of the skin. Hyaluronic acid’s molecular weight is significantly dependent on its source; however, refinement of the isolation procedures has resulted in the commercial availability of a wide range of molecular weight grades.The physical properties of Sodium hyaluronate are mentioned below:Purified Sodium hyaluronate is a white powder with no taste or aroma.The molecular weight of the Sodium hyaluronate molecule is around 4,000 to 80,00,000 Daltons.Sodium hyaluronate has high solubility and viscosity.It provides excellent moisture-holding ability and elasticity, as well as a lubricating effect.Sodium hyaluronate is compatible with biological systems.It degrades with heat, enzymes, etc. but can be stabilized by crosslinking.It is stored as a dry powder at 5°C and as a solution at -20°C or lower.Sodium hyaluronate is photosensitive and moisture sensitive, so it should be kept away from light and humidity.Based on its degree of penetration, HA can be classified into high molecular weight Hyaluronic acid (HMW HA) > 18,00,000, middle molecular weight Hyaluronic acid (MMW HA) 10,00,000 - 18,00,000, low molecular weight Hyaluronic acid (LMW HA) 4,00,000 - 10,00,000, small molecular weight Hyaluronic acid: 1,00,000 - 4,00,000 and extra small molecular weight Hyaluronic acid: < 100,000.The high molecular weight Hyaluronic acid moisturizes the surface of the skin, protects the skin’s barrier, and improves its elasticity. It also contains anti-inflammatory properties that can help soothe sensitive or irritated skin. Low molecular weight Hyaluronic acid, on the other hand, can more easily penetrate the skin and is most effective in reducing wrinkles. In addition, topical low molecular weight HA can be used as an alternative to treat facial seborrheic dermatitis.What are the different applications of Sodium hyaluronate in the pharmaceutical and cosmetic industries?Hyaluronic acid is a naturally occurring polysaccharide biopolymer. It is involved in a variety of biological processes including tissue hydration and structural scaffolding. Sodium hyaluronate is increasingly being used as a reagent in pharmaceutical, bioengineering, and medical applications. Exogenous Sodium hyaluronate has been investigated as a drug delivery system for treating cancer, ophthalmology, arthrology, pneumology, rhinology, urology, aesthetic medicine as well as in the cosmetics industry.Sodium hyaluronate is used in numerous pharmaceutical and cosmeceutical applications which include:Drug Delivery Systems: Hyaluronan is biocompatible, viscoelastic, and non-immunogenic. These Sodium hyaluronate characteristics have several medical applications in drug delivery for ophthalmic, nasal, pulmonary, parenteral, and dermal routes.Scaffolds for Tissue Engineering: As a component of the extracellular matrix (ECM), Sodium hyaluronate is responsible for various structural properties of tissues and is involved in cellular signaling. Scaffolds made of Sodium hyaluronate are employed in bone tissue, space-filling, nerve, and brain tissue repair, as well as cell delivery, cell adhesion, and muscle regeneration.Adjuvant to Anticancer Drugs: Medical applications of Hyaluronic acid include its use in the delivery of anticancer drugs because of its superior biocompatibility, biodegradability, and precise targeting of cancer cells.Intra-Articular Injection: Sodium hyaluronate is taken as a supplement alone or in conjunction with collagen, vitamins, chondroitin sulphate, or glucosamine for joint-related problems as well as for the treatment of osteoarthritis. Hyaluronic acid binds efficiently to water, forming a viscous fluid that serves as a lubricant and a shock absorber within the joint. It also helps to increase bone density, mobility, and strength.Ophthalmic Viscosurgical Devices: Ophthalmic grade Sodium hyaluronate is commonly used in viscosurgical devices (OVDs), which are essential in ophthalmic surgeries like cataract extraction, cornea transplantation, glaucoma, intraocular lens (IOL) implantation and vitreoretinal surgery. Sodium hyaluronate is a naturally occurring component of the eye’s vitreous humor and is entirely biocompatible.Eye Moisture Retention: Sodium hyaluronate eye drops can alleviate dry eye symptoms by boosting tear production and stabilizing the corneal surface. Eye drops with high-molecular-weight Hyaluronic acid have anti-inflammatory properties.Wound Healing: In topical preparations, Sodium hyaluronate is used to protect skin ulcers, burns, or wounds from irritation, allowing the skin to heal properly. Hyaluronic acid works to heal wounds by producing the granulation tissue required for wound repair.Skin Benefits of Sodium Hyaluronate: Hyaluronic acid can retain moisture in the extracellular matrix formed in the gaps between cells. Its topical treatment hydrates the skin and keeps it hydrated as a humectant. Sodium hyaluronate is used in anti-aging preparations to help minimize the skin roughness, considerably reduce wrinkle depth and improve skin firmness and elasticity.Dermal Fillers: Hyaluronic acid injections can be used to improve the skin's contour and decrease depressions caused by scars, injuries, or lines. Dermal fillers containing Sodium hyaluronate have been used to treat wrinkles, nasolabial folds, and fine lines around the mouth, lips, cheeks, chin, etc.Furthermore, Hyaluronic acid promotes cell proliferation, cell differentiation, and immunosuppression, and is a component of submucosal injection and resorbable adhesion barriers.In addition, high molecular weight Sodium hyaluronate forms a moisture protecting film at the surface of the skin, helps the skin to hold moisture, inhibits bacterial growth, and reduces UVB-induced apoptosis and inflammation in human epithelial corneal cells. Middle molecular weight Hyaluronic acid helps tighten the skin and keep it moisturized for a long time.Low molecular weight Hyaluronic acid, on the other hand, is smaller, penetrates deeper into the dermis, moderately dilates capillaries, increases blood circulation, and ensures that water is stored in the connective tissue of the skin, making skin firmer and reduces visible wrinkles.How is Kewpie considered a pioneer in the pharmaceutical industry for manufacturing Sodium hyaluronate?Kewpie is a leading Japanese pharmaceutical grade Sodium hyaluronate manufacturer and supplier. It manufactures Hyaluronic acid which is used as an API and a pharmaceutical excipient. It created the first Sodium hyaluronate from chicken comb.Since 1983, Kewpie has been a pioneer Hyaluronic acid manufacturer and supplier. Its R&D team can develop Sodium hyaluronate derivatives to meet the needs of the clients. Kewpie extracts and refines different active ingredients for foods, cosmetics, and pharmaceuticals at its fine chemicals division. It has been developing and manufacturing medical devices using Sodium hyaluronate since 2016.Kewpie is one of the leading Sodium hyaluronate suppliers, exporting Sodium hyaluronate to more than 30 countries. It is a prominent pharmaceutical grade Sodium hyaluronate manufacturer in Japan and can meet the clients’ requirements for tailor-made derivatives. To assure the supply of safe products, Kewpie’s production and quality control (QC) systems are based on Good Manufacturing Practice (GMP). It follows procedures and conducts quality testing at every stage, from receiving raw materials to manufacturing and shipping, and has developed control systems to ensure quality.Kewpie is a leading Sodium hyaluronate producer, offering pharma grade, medical grade, ophthalmic grade, and cosmetic grade Sodium hyaluronate with molecular weights ranging from 800 Da to 35,00,000 Da. It can meet the specific needs of the clients by adjusting the molecular weight. Kewpie not only offers products of biofermentation origin, but it also has natural products, thanks to its advanced extraction and refining technology.Kewpie provides custom-made Sodium hyaluronate derivatives by binding other functional compounds to Sodium hyaluronate, which can acquire new functions and physical characteristics. Kewpie promotes the timely development of products with technical support from R&D experts and regulatory support.Kewpie offers high-quality pharmaceutical grade Sodium hyaluronate. It can produce highly pure and stable products that can maintain the safety and efficacy of the final drug by using its manufacturing knowledge.Kewpie offers ophthalmic grade, pharma grade as well as food, cosmetic and medical grade Sodium hyaluronate. Its Sodium hyaluronate is good for injections, eye drops (ophthalmic solutions), pharmaceuticals, external preparations, and medical formulations.Production of Hyaluronic acid at Kewpie’s facility occurs through two methods - microbial fermentation and extraction from chicken comb. Kewpie has completed several Hyaluronic acid R&D projects since 1983. Kewpie is a leading producer of Hyaluronic acid. It has the technology to control the molecular weight of Sodium hyaluronate to produce it according to customers' needs.Various products developed and offered by Kewpie include Hyabest®(A), Hyabest®(J), Hyabest® (S) LF-P, Hyalo-Oligo®, Hyaloveil®-P, Hyalorepair®, and HAbooster™ which are mentioned in detail below:- Hyabest®(A): It is a low-molecular weight Hyaluronic acid with anti-inflammatory and other properties.- Hyabest®(J): It is an injectable Hyaluronic acid that works on joints.- Hyabest® (S) LF-P: It is an edible version of Hyaluronic acid that is effective against skin damage from ultraviolet radiation. So, it acts as an anti-aging substance.- Hyalo-Oligo®: It has a different moisture retention mechanism from other products. So, it is used in parallel with conventional products.- Hyaloveil®-P: It acts as an adsorbent of Hyaluronic acid for hair and skin and continues to retain moisture.- Hyalorepair®: It is a blend of oil with Hyaluronic acid. It restores the barrier function, preserves skin moisture, and repairs rough skin.- HAbooster™: In addition to the functionality of conventional Hyaluronic acid in retaining skin moisture, it acts to promote collagen metabolization.Kewpie is a pioneer Sodium hyaluronate producer. It produces its products in accordance with Good Manufacturing Practices. It is also one of the leading Sodium hyaluronate suppliers in the world.What are the different grades of Sodium hyaluronate (Hyaluronic acid) offered by Kewpie?Kewpie is a Hyaluronic acid manufacturer and supplier that has been in research for more than 30 years. Kewpie offers safe to use pharma grade, cosmetic grade, food grade, and medical grade Sodium hyaluronate.Pharmaceutical Grade Hyaluronic AcidKewpie is a pharmaceutical grade Sodium hyaluronate manufacturer, which produces various Sodium hyaluronate grades, including injectable grade and ophthalmic grade HA at its manufacturing facility near Tokyo. It is a producer of Hyaluronic acid for eye drops, injections, as well as external preparations.Kewpie manufactures purified Sodium hyaluronate as hyaluronsan HA-AML and hyaluronsan HA-SHL. These are usually used in pharmaceuticals like auxiliary agents for eye surgery and therapeutic agents for osteoarthritis of the knee joint.Kewpie provides various injectable and medical grade Sodium hyaluronate products in powder form, including HA-AML, HA-SHL, HA-AM, and HA-QSE.- Hyaluronsan HA-AML: It is purified Sodium hyaluronate that has an average molecular weight of 500 - 1,200 (kDa) and is obtained via the biofermentation method. It has registered and certified GMP, CEP, and DMF in Japan, the USA, China, and Korea.- Hyaluronsan HA-SHL: It is also a purified Sodium hyaluronate with an average molecular weight of 1,500 - 3,900 (kDa) and is obtained via biofermentation method. It has registered and certified GMP, CEP, and DMF in Japan, the USA, and China.- Hyaluronsan HA-AM: It is obtained via the chicken comb method and has an average molecular weight of 600 - 1,200 (kDa). It has registered and certified GMP and DMF in Japan, the USA, China, and Korea.- Hyaluronsan HA-QSE: It is also obtained via the chicken comb method and has an average molecular weight of 1,900 - 3,900 (kDa). It has registered and certified GMP and DMF in Japan and Korea.Cosmetics Grade Hyaluronic AcidKewpie, a leading producer of Hyaluronic acid, uses Hyaluronic acid products to improve skin problems. Kewpie’s Hyaluronic acid powder series hyaluronsan HA−LQ and hyaluronsan HA−LQH are produced using the microbial fermentation method. These products have higher water and moisture retention qualities and can help in preventing dryness of the skin and hair.Cosmetics Grade Functional Hyaluronic AcidKewpie is a Sodium hyaluronate producer and a leading global functional ingredient Sodium hyaluronate supplier. Kewpie’s functional Hyaluronic acid is not an ordinary humectant. In addition to the high water retention and moisturization qualities that general Hyaluronic acid has, Kewpie adds new functions through its unique technologies.Kewpie’s functional Hyaluronic acids are scientifically proven to cater to client’s specific needs and use. Kewpie’s functional Hyaluronic acids can help in having healthy and vibrant skin. Functional Hyaluronic acids include HAbooster™, Hyalo-Oligo®, Hyaloveil®-P, and Hyalorepair®.- HAbooster™: It is a very low-molecular weight Sodium hyaluronate. It promotes the collagen cycle, increases skin moisture, and improves crow’s feet and nasolabial folds. Its topical application enters the upper layer of the epidermis of the skin and promotes collagen metabolism to improve wrinkles and sagging.- Hyalo-Oligo®: It not only covers the skin’s surface but penetrates deep into the horny layer and contributes moisture to the skin. Conventional Hyaluronic acid remains on the skin's surface and is easy to wash off. However, Kewpie’s Hyalo-Oligo® increases the amount of moisture in the skin twofold. Even after washing the face, the moisture retention capability of Hyaluronic acid remains.- Hyalorepair®: It is an alkylated low-molecular weight Hyaluronic acid that has barrier function recovery with both hydrophobic and hydrophilic aspects for skin care. Its Hyalorepair® suppresses skin’s water evaporation.- Hyaloveil®-P: It is a high molecular weight Sodium hyaluronate that has been cationized, has an adhesive and coating effect, and veils skin and hair moisture.Food and Nutraceutical Grade Hyaluronic AcidKewpie is a Hyaluronic acid manufacturer and supplier that provides assurance regarding the safety of its Sodium hyaluronate. The production of Hyaluronic acid at Kewpie occurs through the extraction of chicken comb and microbial fermentation methods through its quality assurance system. Its nutraceutical grade Hyaluronic acid includes Hyabest®(A), Hyabest®(J), Hyabest(S)LF-P, and Hyabest®(S)LF5-A.- Hyabest®(A): It is Sodium hyaluronate produced using proprietary technology. Hyabest®(A) acts physiologically to relieve skin inflammation.- Hyabest®(J): It is the world's first Hyaluronic acid,  which when taken orally, has been proven to be efficacious for knee joint pains.- Hyabest(S)LF-P: It is highly pure Sodium hyaluronate and is used for dietary supplements. Sodium hyaluronate helps retain moisture in the skin and helps avoid dryness.- Hyabest®(S)LF5-A: It is Hyaluronic acid that is produced using the fermentation method, and then purified to get high-purity compounds. It can be used for mixing with beverages to provide high moisture retention.

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https://www.pharmacompass.com/pharma-blog/pharmaceutical-grade-sodium-hyaluronate-manufactured-by-kewpie

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July, 2023
View Sharp`s clinical trial supply & contract pharmaceutical packaging services, including blisters, bottles, sachets, pouches & PFS on PharmaCompass.
View Sharp's clinical trial supply & contract pharmaceutical packaging services, including blisters, bottles, sachets, pouches & PFS on PharmaCompass.What is Sharp and what services does it offer? Sharp is a global leader in clinical trial supply chain services and contract pharmaceutical packaging, with a history dating back more than 70 years. Sharp provides solutions and support starting from phase I clinical trials and continuing through commercial launch and lifecycle management.Its network of GMP facilities provides worldwide reach, production scalability, and risk mitigation by validating several identical lines across its network. Sharp comprises two dynamic international divisions, Sharp packaging solutions, and Sharp clinical services. Its 1,600-strong team works from state-of-the-art facilities in the US, the UK, Belgium and the Netherlands.Sharp provides pharmaceutical formulation development, contract manufacturing, comparator sourcing, primary and secondary packaging with labeling, storage and distribution services as part of its clinical trial supply services. It also offers direct-to-patient solutions, clinical trial technology solutions (Clinteract and Clinventory) with project management as well as gene therapy clinical trial services.As part of its commercial packaging services, Sharp provides blister and bottle for primary and secondary packaging, oral thin film and transdermal patches along with pouches and sachets (primary and secondary), kitting and gene therapy commercial packaging services. It also offers packaging design services, serialization and aggregation along with project management and commercial packaging.Along with contract packaging of oral solid dosage forms, Sharp offers packaging services for injectables, such as vial, autoinjector, pen assembly, pre-filled syringe (PFS) assembly, labeling and packaging with small-scale sterile fill-finish capabilities.Sharp supports integrated clinical trial supply services and commercial packaging services with a broad range of capabilities and deep expertise. It provides both shared production lines and dedicated technologies with suites as per the needs of the customer.What are some of Sharp's clinical manufacturing services?Sharp's clinical services division is the world leader in providing innovative clinical supply chain services, with a highly experienced team that can handle all aspects of the client's supply chain.Sharp assists clients in navigating their journey to market by lowering the risk, time, and complexity of their clinical trials. Its responsibilities include everything from product development and production to clinical supplies packaging, labeling, distribution, qualified person audits, and comparator sourcing. Sharp provides various clinical trial services, which are listed below:Pharmaceutical Product Development: Sharp assists clients in navigating their formulation development challenges and commercialization problems. It also offers product development services for a wide range of oral solid dosage forms, including immediate, modified, delayed, extended-release, controlled-release tablets and capsules, as well as orally disintegrating tablets (ODTs).It offers clinical manufacturing of various dosage forms that contain highly-potent compounds, DEA controlled substances (schedule I-V), a combination of multiple APIs and placebos (solid, semi-solid, and liquid dosage forms). It also allows over-encapsulation for double-blind tests with enhanced bioavailability. Contract Manufacturing: Sharp provides customized clinical manufacturing solutions and a broad range of contract development and manufacturing capabilities for complex dosage forms such as modified release tablets and capsules, including mini tablets, fixed-dose combination products, and powder in sachets.Sharp ensures the integrity of clients' double-blind studies by designing, developing and manufacturing placebos and trial doses that correspond to the client's drugs and existing comparators, supporting development services and reformulations in phases I-IV. It also provides clinical manufacturing for liquids and semi-solids such as true solutions, nasal sprays, powders for reconstitution or suspensions and gels.Sharp, in collaboration with innovative sterile manufacturer Berkshire Sterile Manufacturing (BSM), provides clinical scale isolator-based sterile filling of syringes, vials, and cartridges. The use of isolator-based filling technology eliminates the risk of human contamination throughout the formulation and filling processes. Sharp also offers global comparator sourcing, procurement, and blinding to ensure the scientific credibility of clinical trials.Comparator Sourcing: Sharp not only sources reliable materials, but also delivers integrated services such as packaging and labeling, as well as over-encapsulation of oral solid dosage forms and the production of placebo capsules for study blinding.Primary Packaging: Sharp is a reliable clinical packaging partner. It provides isolator-based sterile fill-finish,  a wide range of primary clinical packaging services, and complementary clinical supply chain capabilities. Sharp is also a cold-chain specialist, handling products at -70°C and conducting secondary packaging and labeling at 2-8°C and -20°C. Labeling and Secondary Packaging: Sharp provides a comprehensive range of rapid and scalable labeling and secondary packaging services across all formats, spanning the whole lifecycle of a client's investigational medicinal product (IMP). Sharp also supports cold-chain labeling and packaging from 2-8°C to -70°C. It has a design and logistics team to assist clients in addressing the challenges of blinding the products that are ready for trial. Sharp's clinical labeling expertise can help customers efficiently package clinical trial IMP for patients from any region. It designs and prints multi-language clinical labels for customers all around the world. Storage and Distribution: Sharp provides customized and regulatory guidance on the storage, distribution and on-time delivery of clinical trial materials around the globe. Sharp has strong cold-chain capabilities, including ambient, chilled, and ultra-low frozen storage and distribution, as well as approved temperature monitoring devices.Direct-to-Patient Solutions: Sharp provides global distribution services and is ready to meet clients' requirements for direct-to-patient clinical supplies. A decentralized clinical trial approach brings specific considerations for optimizing the clients' distribution chain for direct-to-patient clinical trials.Clinical Trial Technology Solutions: Sharp has created a suite of clinical trial solutions to help clients manage their trials more effectively. Sharp has expertise in successfully managing patient interactions and drug supply during clinical trials, thanks to its considerable experience in providing clinical IRT (Interactive Response Technology) services.  Sharp is designed to successfully handle patient interactions and drug supplies for clinical trials. Clinventory offers all the benefits of the IRT's clinical trial supply chain management, but without the additional costs of subject randomization and management.Gene Therapy Clinical Trial Services: Sharp collaborates with clients to bring their gene therapies efficiently and safely through clinical trials. Based on its experience and capabilities in small-scale supply and clinical trial supply services, Sharp is ideally positioned to support clients with dedicated solutions for their gene therapy trials. What range of contract commercial packaging solutions does Sharp offer?Engineered to deliver on time, in full, and to the highest quality, Sharp has established itself as a reliable partner for pharmaceutical and biotech packaging. Sharp has an exceptional global reputation for designing, serializing and manufacturing innovative, cost-effective compliance packaging for even the most complex products. Sharp's list of extensive services comprises blister packs, bottles, pouches, and stick packs, but its expertise extends far beyond every stage of contract development and manufacturing to design and delivery. Its mission is to provide unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industries.The various commercial packaging services offered by Sharp are listed below:Bottles (Primary and Secondary): Sharp specializes in pharmaceutical oral solid dosage form bottling and packaging services, offering extensive expertise and flexibility to ensure product stability. With its state-of-the-art facilities and advanced equipment, Sharp can handle a wide range of bottle and solid oral dose shapes and sizes. Its precise equipment, coupled with in-line fill sensors and check weighers, guarantees accurate fill count for the packaged drug products. By providing comprehensive packaging solutions, Sharp ensures that pharmaceutical products are packaged efficiently and maintain their quality throughout the process.Its bottle packaging services include component sourcing, carton printing and in-line cartoning or bundling, extensive onsite engineering and validation support, serialization and aggregation, and strict quality control to ensure that clients' drugs are packaged to the highest standards.Blisters (Primary and Secondary): For over 65 years, Sharp has been a leader in the blister packaging of pharmaceutical oral solid dosage forms. Sharp is a market leader in pharmaceutical oral solid dose blistering due to its extensive expertise, understanding of global regulatory and compliance challenges, and comprehensive capabilities.Sharp assists clients in choosing the best blister pack format, material and methods based on their drug specifications. The packaging design team at Sharp uses cutting-edge software and technology to provide extensive services, ensuring the clients' drug packaging is both patient-friendly and visually appealing in the market.Engineering Services: The engineers at Sharp are dedicated to continuous innovation and exploring new approaches that bring value, improve operational efficiencies and reduce risk. Whether a client chooses to leverage Sharp's labeling and packaging line equipment or require a custom-designed packaging line, its engineers offer expert guidance and recommendations for both common and challenging packaging requirements.Injectable Packaging: Sharp provides customized packaging services specifically designed for injectable products, catering to both small and large-volume batch sizes. With a focus on flexibility, Sharp can deliver swift launches across multiple countries from its injectable centers of excellence in the US and EU. Sharp specializes in cold chain storage, temperature and light-controlled packaging, serialization, and specialty distribution. It offers comprehensive contract pharmaceutical packaging services for a wide range of injectable devices, including vial labeling, autoinjector and pen assembly, labeling and packaging for pre-filled syringe (PFS), cartoning and kitting as well as small-scale sterile fill finish.Sharp also provides packaging design services for injectable products. Its global design team works in collaboration with clients to understand their product specifications and propose the most suitable solutions for vial, pre-filled syringe (PFS), and autoinjector packaging for drug launches and sampling programs. Sharp offers a wide range of solutions for autoinjector or pen devices, available at its packaging facilities in the US and EU. Sharp has the capability to design and run a dedicated line for autoinjector or pen devices. It can also handle the labeling and packaging requirements for various pre-assembled autoinjector and pen devices currently available in the market. Sharp enhances its core packaging services by offering essential capabilities for biotech drugs. These include packaging design, cold chain storage, packaging in temperature and light-controlled environments, serialization and specialty distribution.Sharp offers scalable vial labeling and packaging services through its team of experts and best-in-class packaging systems. Sharp is an industry leader in assembly, labeling, and packaging and has extensive experience delivering pharmaceutical and biotech pre-filled syringe (PFS) packaging solutions from its facilities in the US and EU.By leveraging its technical expertise and unique capabilities, Sharp can accelerate the market introduction of client's injectable formulations. Through its partnership with Berkshire Sterile Manufacturing (BSM), Sharp offers a seamless and comprehensive range of high-quality, end-to-end clinical manufacturing, contract manufacturing, packaging, and distribution solutions for injectables. BSM is a specialized contract manufacturer that utilizes a unique 100% isolator-based sterile fill-finish system in its production lines, delivering complete sterile assurance and unparalleled quality in formulation development and filling processes. Serialization and Aggregation: Sharp is an industry leader in serialization. Its serialization and aggregation services guarantee adherence to stringent global regulations designed to improve the security of the drug supply chain and safeguard patients. Kitting: Sharp offers a comprehensive range of customized kitting solutions for biotechnology, pharmaceuticals, and medical devices industries. These solutions are designed to efficiently package multiple components into a single, self-contained package. Design Services: Sharp's team of design engineers, structural engineers, and graphic designers, with their knowledge of regulatory and supply chain challenges, position the company as a market leader in the design and delivery of secondary pharmaceutical packaging. With years of experience in developing innovative packaging, Sharp's designers provide expertise in brand development, existing artwork modification, FDA submission requirements, marketing studies, 3D rendering (3D printing), child resistant/senior friendly compliant packaging design, packaging samples, tray design, and shipper and pallet design.Oral Thin Film and Transdermal Patches (Primary and Secondary): Sharp specializes in the primary and secondary packaging of oral thin films and transdermal patches. It offers specialized packaging services through quality processes, and has extensive expertise in die-cutting and pouching sublingual and oral dissolvable films, as well as transdermal drug delivery systems. With decades of experience in contract pharmaceutical packaging, Sharp possesses comprehensive capabilities and is supported by quality operations and project management expertise. This enables Sharp to provide the best packaging solution to protect specialty drug format.Pouches and Sachets (Primary and Secondary): Sharp provides expertise in pouch and sachet filling for a wide range of products, including solid dose, powder, thin film, and transdermal patch formulations. With a robust assembly of form, fill and seal technology, Sharp offers extensive capabilities in pouch/sachet packaging, supported by its commitment to quality operations and project management expertise. By utilizing its precision-engineered technology, Sharp offers various sealing techniques for 4-sided pouches, weight verification as well as labeling and printing directly onto sachet material.Gene Therapy Commercial Packaging: As a leading commercial packaging provider with 70 years of experience handling complex pharmaceutical packaging requirements, Sharp is well-equipped to deliver specialized services tailored to meet the requirements of its clients. It offers the best blend of both clinical and commercial expertise, ensuring that gene therapies reach patients who need them. Gene therapies, unlike traditional therapies, follow patient-led 'demand chains' that require a whole new approach to supply chain support. What is the difference between primary and secondary packaging? How does Sharp handle the complexity of pharmaceutical packaging?Effective packaging plays a vital role in the pharmaceutical industry. It ensures the protection of the drugs during storage, sale, shipping, and use. The packaging of pharmaceutical products also depends on the type of drugs, considering potential reactions between the drug and its packaging. The packaging protects the contents from any external factors, such as physical, chemical, or biological influences that could potentially alter the properties of the products. In the pharmaceutical industry, packaging differs from drug to drug and is classified into primary and secondary packaging.Primary Packaging: Primary packaging is the packaging in direct contact with the product. It is often referred to as retail packaging or POS (point-of-sale) packaging. The main purpose of primary packaging is to preserve the product and inform the consumer. Examples include ampoules and vials, pre-filled syringes (PFS), IV containers, blister packs, etc.Some of the most common types of primary pharmaceutical contract packaging are:BlistersStrip PacksAmpoules and VialsBottlesSachets & PouchesSyringesSecondary Packaging: Secondary packaging refers to the packaging that protects the primary packaging, such as cartons, boxes, shipping containers. Secondary packaging is important for several reasons, including physical and barrier protection, brand exposure, easy product handling, ensuring regulatory compliance and the safety of the patients. Additionally, it facilitates the transportation of goods from the manufacturer to the end user.Secondary packaging includes vital information such as ingredients, manufacturer details, warning, and the type of medicine. Secondary packaging offers several benefits, including streamlining the shipping process and reducing the risk of damage during transportation.The various types of secondary packaging include, but are not limited to the following:CartonsPlastic CratesBoxesTraysBundles & WrapsA drug product is carefully formulated to ensure the maximum therapeutic benefit. However, when the drug product interacts with its packaging, there is a possibility of it being chemically altered, which can potentially diminish its therapeutic benefit. Pharmaceutical and biotech companies face several challenges when it comes to packaging. These include ensuring proper handling and transportation of the products, retaining the medicinal qualities of the products, providing important information related to medication, incorporating scannable codes for effective inventory management, addressing child-safety issues, adopting eco-friendly packaging solutions, accommodating new biologics, promoting sustainability, preventing counterfeit products, and promoting awareness and education among medical practitioners and consumers. In addition to these challenges, some regulatory requirements like anti-tampering measures, adherence to multi-layered labeling regulations, and compliance with pharmacopeia standards to cater to the global market, play a crucial role. Sharp offers various packaging solutions to address the above mentioned challenges faced by the pharmaceutical industry:Sharp ensures product stability by providing the best commercial scale packaging solution for drug products. Using highly precise equipment, Sharp can handle the full range of bottle and solid oral dose shapes and sizes. It uses in-line fill sensors and check weighers to confirm fill count accuracy.Its bottle packaging services encompass component sourcing, carton printing and in-line cartoning or bundling, comprehensive onsite engineering and validation support, serialization and aggregation, and strict quality control, to ensure that drugs are packaged to the highest standards.Extensive expertise, a thorough understanding of global regulatory and compliance challenges, and comprehensive capabilities has established Sharp as a market leader in pharmaceutical oral solid dose blistering. Its packaging design team uses cutting-edge software and technology to provide comprehensive services that ensures the packaging of a drug is patient-friendly and that the product stands out in the market.Sharp specializes in cold chain storage, packaging in temperature and light-controlled environments, serialization, and specialty distribution. Sharp offers contract pharmaceutical packaging services for a wide range of injectable devices, including vials, autoinjectors,  pen assembly, pre-filled syringe (PFS), etc.Sharp's global design team collaborates with clients on their product specifications, proposing the best packaging solutions for vials, pre-filled syringes (PFS), and autoinjectors for drug launch and sampling programs. Sharp offers a diverse range of customized kitting solutions for biotechnology, pharmaceuticals and medical devices, that require the packing of multiple components into a single self-contained package. With a focus on quality processes, Sharp specializes in providing packaging services, Sharp has extensive expertise in die-cutting and pouching sublingual and oral dissolvable films and transdermal drug delivery systems. Backed by decades of experience in contract pharmaceutical packaging, Sharp combines comprehensive capabilities with quality operations and project management expertise to deliver the best packaging solutions for protecting specialty drug formats.For gene therapy products, Sharp provides commercial packaging solutions that include batch sizes as small as 1 vial, just-in-time or better on-demand processes, fast turnaround times for packaging, labeling and distribution as well as cold, ultra-cold or even cryogenic storage.

Impressions: 998

https://www.pharmacompass.com/pharma-blog/pharma-contract-packaging-clinical-manufacturing-services-offered-by-sharp

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June, 2023
View Metrochem API`s portfolio of APIs, Intermediates & Pellets (Semi-finished formulations) & explore Metrochem`s R&D activities on PharmaCompass.
View Metrochem API's portfolio of APIs, Intermediates & Pellets (Semi-finished formulations) & explore Metrochem's R&D activities on PharmaCompass.Q1. What is Metrochem API and what are its product offerings?Metrochem API is one of the fastest-growing Indian manufacturers of active pharmaceutical ingredients (APIs), pellets (semi-finished formulations) and intermediates. It provides customized volumes and quality products to its clients all over the world.The company has six dedicated manufacturing facilities for its three core product groups - active pharmaceutical ingredients (APIs), pelletization and intermediates. These facilities, along with a well-equipped, centralized R&D laboratory, allow it to meet the high volume demands of its clients.Metrochem API focuses on innovation across people, processes, products and technology through knowledge exchange and cross-functional collaboration. Its research center in Hyderabad has three fully functional laboratories along with an analytical laboratory. It provides custom research and custom synthesis services as well.Metrochem API's six manufacturing facilities are located in Hyderabad and Visakhapatnam, India. These manufacturing facilities have received approval from several international regulatory agencies such as the USFDA, WHO GMP, Cofepris, KFDA and PMDA.  Metrochem API offers the following products: APIs - Metrochem API is one of the leading active pharmaceutical ingredient (API) producers in India. It has its own R&D center and has received international FDA approval. It provides a variety of active pharmaceutical ingredients in multiple therapeutic areas, including antiulceratives, antifungals, antidepressants, antihypertensives, antithrombotic, antihistaminic, antilipemic, antiarthritic, anti-inflammatory, antidiabetic, antibacterial and gastoprokinetic. Pellets - Metrochem API also offers pellets (semi-finished formulations) in multiple therapeutic areas, such as antiulceratives, anti-inflammatory, antihypertensive, antihyperlipidemic, antipsychotic, antiemetic, antithrombotic, antispasmodics, antiasthmatic, immunosuppressant, etc. It also offers blended, combination, taste-masking pellets and micro granules for direct compression. Intermediates - Metrochem API makes various intermediates, including N-Benzylaniline, Pyridine-2-carbaldehyde, 1-bromo-4-chlorobenzene, 2-Hydroxymethyl-4-(3- methoxypropoxy)-3- methylpyridine, etc. Q2. What R&D activities does Metrochem API focus on?Metrochem API's R&D and manufacturing facilities in India have been constructed to meet the highest quality requirements. Metrochem's R&D center conducts research on APIs and intermediates that involve multi-step synthesis. The company has a proven track record of implementing and developing processes and scaling them up from the lab (kilo) to the commercial level.Metrochem can create new products and meet the demands of life science companies all over the world because of its expertise in research, analytical technique development, synthesis of impurities, organic synthesis, multi-step synthesis, custom synthesis, scale-up and technology transfer.The research center at Metrochem complies with cGLP standards and is focused on organic synthesis, custom synthesis services, analytical research, etc. The primary R&D activities of Metrochem API includes the development of active pharmaceutical ingredients (APIs), advanced intermediates and fine chemicals, with continuous process improvement for cost reduction and the long-term sustainability of its various businesses.Metrochem API offers the technical know-how and cutting-edge equipment necessary to develop analytical techniques for assessing the quality of raw materials, advanced intermediates and finished products. With the use of sophisticated instruments like GC-MS/MS, multi nuclei NMR, preparative HPLC, HPLCs with detectors like UV, RI, and PDA, and GCs, it is capable of analyzing the impurity profiles and identifying degradation products in their active compounds.The research center in Hyderabad contains three completely equipped laboratories and a well-equipped analytical laboratory spread across a 1,000 sq. meter area. Custom synthesis at Metrochem API is designed to satisfy the requirements of its customers, be they in the laboratory scale-up, commercial scale-up or post-commercialization stages. Metrochem API provides its extensive services along with a guarantee of quality and reliability. These are made available at a rate and cost that are beneficial to both parties.Q3. Where are Metrochem's manufacturing sites located and what is their regulatory inspection history?Metrochem API has emerged as one of India's fastest-growing pharmaceutical organizations. It has six cutting-edge production facilities situated in Hyderabad and Visakhapatnam, India. It has specialized manufacturing facilities for the production of APIs, pellets (semi-finished formulations) & intermediates, which are supported by a well-equipped, centralized research & development laboratory.Metrochem's manufacturing facilities have been approved by several international regulatory bodies such as ISO 9001-2015, USFDA, WHO GMP, Cofepris, as well as PMDA. The facilities have also been inspected by KFDA. The details about some of Metrochem's production units are as follows: Unit I for APIs - It is a dedicated facility located in Hyderabad, India, specializing in the production of active pharmaceutical ingredients (APIs). The facility has ISO 9001:2015, PMDA, WHO GMP and local GMP certification. The site spans across an area of 1006.25 sq. meters and comprises 10 reactors with a total volume of 30 KL. The facility also includes Class 100000 areas, consisting of 176.00 sq. meters for pharma grade manufacturing and 5.55 sq. meters for sampling and dispensing.Unit II for Pellets - The facility is located in Hyderabad, India, and is a dedicated site for the production of pellets (Semi-finished formulations). The facility has ISO 9001:2015, WHO-GMP and local GMP certification. The site spans an area of 1300.00 square meters and has a total of 13 FBC reactors with a capacity of 6,020 Kgs FBCV. Additionally, there are two Class 100000 areas within the facility., covering a manufacturing area of 634.00 sq. meters, while the sampling & dispensing area covers 8.43 sq. meters.Unit B for Intermediates - This facility is located in Sangareddy, India, and is solely devoted to the production of advanced Intermediates. The facility has received an accreditation of ISO 9001:2015.The site is spread over approximately 6.0 acres and has four reactors, including five GLRS and 35 SSRs, with a total volume capacity of 130 KL. The facility also has one class 100000 area.Unit C for Intermediates -  This facility is also situated in Sangareddy, India, and is dedicated to the production of intermediates. The facility has received accreditations from ISO 9001:2015 and USFDA. The site is spread across an area of 26,040 sq. meters and houses 58 reactors (G-14 and SSR-44), with a total volume capacity of 237.101 KL. The facility also includes Class 100000 areas, including a sampling & dispensing area covering 2.86 sq. meters.Unit IV for APIs & Intermediates - Situated in Visakhapatnam, India, this facility is dedicated to the production of APIs & intermediates. It has ISO 9001:2015 and Schedule-M GMP certifications. The site occupies a total area of 386.50 meters and has 129 reactors with a total volume capacity of 715.53 KL. The facility also includes 11 Class 100000 areas, including the manufacturing area and sampling & dispensing area.Q4. What is Metrochem API's approach to environmental sustainability, and how does the company demonstrate its commitment to environmental management?Metrochem API is a responsible manufacturer of active pharmaceutical ingredients (APIs) and advanced intermediates that recognises and values environmental management as one of its top corporate priorities. It operates all aspects of its business as a responsible steward of the environment.According to Metrochem, environmental management must incorporate the principles and practices for protecting the environment, decreasing pollution and conserving natural resources. It believes companies should comply with the relevant laws and regulations and should be committed towards continual improvement.Metrochem API is committed to environmental sustainability and has made it one of its top corporate priorities. The company adheres to relevant laws and regulations and continuously strives for improvement. Metrochem API has established a framework for setting environmental objectives and targets, which are implemented, documented and communicated to all personnel in the organization. Additionally, Metrochem makes its environmental policy available to the public.

Impressions: 1266

https://www.pharmacompass.com/pharma-blog/intermediate-api-pellet-manufactured-by-metrochem-api

Content #LearnMore About Supplier
April, 2023
View Proveris` drug development & contract analytical services for orally inhaled, dry powder & nasal drug products (OINDPs) on PharmaCompass.
View Proveris' drug development & contract analytical services for orally inhaled, dry powder & nasal drug products (OINDPs) on PharmaCompass. Q1. What is Proveris Scientific? What analytical services does it offer? Proveris Scientific delivers innovative testing platforms, laboratory services, contract test services and deep product knowledge to customers who develop, manufacture, or test orally inhaled Dry Powder (DPI) and nasal drug products (OINDPs). For over two decades, Proveris Scientific has collaborated closely with pharmaceutical companies, device suppliers, contract development and research organizations, manufacturing firms and regulatory agencies worldwide. Their shared commitment to raising industry standards and providing effective therapies drives this focus. By comprehending the essential quality attributes that impact the performance of orally inhaled and nasal drug products (OINDPs), Proveris Scientific's team of engineers, scientists, and service professionals can assist you in ensuring successful product development and preventing late-stage development failures. Proveris Scientific's global customer base includes top innovator and generic pharmaceutical companies, device manufacturers, contract development organizations (CDO), contract research organizations (CRO), contract manufacturing organizations (CMO) and regulatory agencies. Proveris conducts comprehensive product testing to gain insights into the challenges of developing OINDP products and ensuring their successful launch into the market. Proveris works in its own laboratory, collaborates with a broad array of industry influencers, and possesses distinctive knowledge and experience in synthesizing the complexities of orally inhaled nasal drug products (OINDPs) to deliver value-oriented solutions to its clientele.  Proveris Scientific offers various analytical services which are listed below: - Proveris assesses the suitability of various OINDP delivery devices for compounds, optimizes device parameters for optimal effectiveness and eradicates testing variables to maintain batch-to-batch reproducibility, thereby streamlining regulatory submissions.  - Proveris Scientific possesses the ability to unravel the intricate relationships between formulation, device, and human usage-essential knowledge required for timely and effective OINDP product development and commercialization.  - Working closely with customers, Proveris can provide immediate insights into critical spray and aerosol parameters, as well as expert advice on the regulatory and operational complexities of orally inhaled Dry Powder (DPI) and nasal drug products. Proveris offers its services to companies working on new product innovations, generic drug development, and commercially released product manufacturers.  - As a pioneering leader in nasal spray analysis and testing and drug development, Proveris Scientific can provide comprehensive assistance at every stage, starting from formulation and device screening, method development, through-life product testing, and regulatory submission. - Proveris Scientific offers an array of services, including hand actuation studies, formulation screening, device selection, droplet size distribution, uniformity of delivered dose, spray content uniformity, spray pattern, plume geometry, pump delivery, fire down (nasal), and pump robustness. - It offers the industry's most complete selection of products and services that specifically focus on metered dose and soft mist inhalers. Along with in vitro inhalation drug analysis, it also provides predictive clinical assessment, bioequivalence and IVIVC studies. - Proveris has recently introduced the INVIDA™ platform, which enables the measurement of aerosol dispersion and regional deposition of inhaled drugs under human-realistic breathing profiles. This cutting-edge technology is a valuable tool for understanding your product's in vivo performance, providing a visual representation of your product's placement within the respiratory tract, along with quantitative measurements of drug deposition.  Proveris Scientific's customer base includes top innovator and generic pharmaceutical companies, device manufacturers, CDO/CRO/CMOs, and regulatory agencies. It is also collaborating with regulatory agencies and leading OTC companies to develop suitable testing methodologies for these products.  Q2. How can Proveris Scientific help you with early development for OINDPs? Proveris Scientific offers innovative testing platforms, contract laboratory services, contract testing services and deep product expertise to customers involved in the development, manufacturing, or testing of orally inhaled and nasal drug products (OINDPs).  - Human Actuation Studies Proveris employs its Ergo™ technology to precisely measure how trained testers in the targeted population uses the product; and the data is immediately transferred for statistical analysis. All key actuation parameters, such as stroke length, velocity, acceleration and hold time, are obtained through the study, and can be adjusted for further optimization. - Method Development Proveris Scientific provides full method development services for all spray characterization tests, including spray pattern, plume geometry and Droplet Size Distribution (DSD), and delivers comprehensive reports in just a few weeks. Proveris-certified methods can be transferred through all stages of the method development cycle, from early development to manufacturing. - Drug Product Characterization Studies Proveris offers drug product characterization studies which includes a range of services, such as analysis of shot weight, spray pattern, plume geometry, droplet size distribution, uniformity of delivered dose, along with inter- and intra-container product testing, storage effect or dosing orientation, and product actuation force evaluation. - Device Screening Proveris Scientific provides device screening services for inhalation and nasal products, which involve assessing the actual spray performance of all formulation and device combination candidates and evaluating all critical quality attributes (CQAs) to identify the best device-formulation pairing. - Novel Device Characterization Proveris Scientific offers novel device characterization services that includes characterization of unit/bi dose devices, syringes with atomizers, nasal powders, topical spray continuous valves and other innovative devices. Q3. How does Proveris help in the development of Unit-dose Nasal Drugs? Developing a successful unit-dose nasal spray or unit-dose nasal powder is a complex process that requires a thorough understanding of the interactions between formulation, device, and human usage. Proveris Scientific has over 25 years of experience in the development of orally inhaled and nasal drug products (OINDPs), and can provide valuable insight and understanding to accelerate product success. Proveris Scientific offers contract testing services in its cGMP-compliant lab to evaluate the complex relationships between formulation, device, and human usage.  Human actuation studies are carried out with trained testers using its patented Ergo™ technology, while screening experiments are performed following the controlled Proveris by Design™ approach.  Viota® Unit-Dose software is optimized to control the unique requirements of unit-dose devices, resulting in increased accuracy and precision in a robust format. The software works with spray, syringe, pressurized aerosol devices, and both liquid and powder formulations for systemic (central nervous system, immune system), nose-to-brain, and local delivery. Product characterization services include evaluation of delivered dose, droplet size distribution, actuation force, spray Pattern (SP), plume Geometry (PG), plume velocity, force to actuate, nasal deposition, and airway deposition. Q4. What are some of Proveris' product offerings? Proveris Scientific offers analytical method development and contract testing services along with various oral and inhalation products that are given below: SprayVIEW® Measurement System It has been designed to meet rigorous testing standards for orally inhaled and nasal drug products (OINDPs). It sets the industry standard for measuring and analyzing spray pattern and plume geometry that are produced by spray and aerosol generating devices. This system has been validated and is being used in the development and production of OINDPs by leading pharmaceutical companies, contract development organizations (CDOs), contract research organizations (CROs) and contract manufacturing organizations (CMOs), device manufacturers, and regulatory agencies worldwide. Vereo : Automated Actuators for PMDI Inhaler Devices  It delivers unrivaled performance for automated actuation. Automated actuation and shaking of pMDI devices eliminates the variables associated with manual actuation and ensures consistent parameters across tests. It provides precise and reproducible control over stroke length, contact and end-of-stroke limits, actuation velocity, hold time and release velocity..  Kinaero CX : PMDI Collection System By utilizing the unrivaled performance of the Vereo® Automated Actuator, the Kinaero Cx offers a dependable automated solution that enhances the consistency of sample collection for testing delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD). The Kinaero Cx enables precise control over shaking parameters, shake-to-fire timing, actuation parameters, and flow rate, ensuring reproducible results. Kinaero: High-Throughput PMDI Fire-Down System The Kinaero™ High-Throughput Fire-Down System is a solution designed to precisely automate shaking and actuation of up to 10 devices simultaneously, ensuring consistent dose delivery for every shot throughout the devices' lifespan. This is necessary because improper manual shaking and shake-to-fire intervals during testing can result in variations in delivered dose ranging from 75-320% of the label claim per actuation.  Accessories  Device Holders :  Proveris' experts work with its customers to create custom device holders that allow human-realistic automated actuation. Proveris Scientific's expertise in OINDP extends to the creation of custom device holders for OTC products, including continuous valve spray cans, fragrance pumps, and other household products. Universal Cassettes : For its Kinaero high throughput pMDI fire-down system, Proveris Scientific offers three main device cassette options compatible with over 20 currently marketed MDI device designs.  Spray Content Uniformity and Waste Collection Kits  These ergonomic and user-friendly kits offer a simple solution for waste and sample collection across a wide range testing applications. The easy-on/easy-off design allows integration with other test workflows such as Droplet Size Distribution (DSD) and Spray Pattern (SP) analysis. Sample Collector Kit : It is designed for spray content uniformity and pump delivery of delivered dose weights. Its precise nozzle tip alignment ensures complete spray collection and eliminates sample loss associated with "spray and flip" manual methods. It standardizes collection for consistent technique across lab operators to eliminate user variability. It includes a sample tube cap for sample processing.

Impressions: 951

https://www.pharmacompass.com/pharma-blog/analytical-contract-services-oindps-offered-by-proveris-scientific

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March, 2023
Overview of Mikart`s CDMO services, such as controlled substance formulations, oral solids & non-sterile liquid dosage forms on PharmaCompass.
Overview of Mikart's CDMO services, such as controlled substance formulations, oral solids & non-sterile liquid dosage forms on PharmaCompass. Q. What is a pharmaceutical CDMO? A pharmaceutical contract development and manufacturing organization (CDMO) is a company that provides drug development and manufacturing services on contractual basis. A contract development and manufacturing organization not only manages the outsourced production of drug substances and products, but also manages all of the research and development activities that occur before drug product manufacturing. The demand for contract development and manufacturing organizations has gone up due to the complexities and considerations brought on by the increasingly unique finished formulations in the market. Because of this reason, many pharmaceutical companies are outsourcing their drug product development and manufacturing requirements to CDMOs. The pharmaceutical contract development and manufacturing organization (CDMO) sector is promptly addressing the challenges within the industry. Pharmaceutical companies are increasingly relying on CDMOs to gain access to specialized expertise, control costs and considerably speed up the successful formulation development through clinical trials and commercial production. The CDMO industry offers opportunities such as technological advancements, new operational techniques, higher company values and high profitability. Pharma companies hire CDMOs so that they can focus more on the primary attributes  of their projects. Q. What are the different services offered by pharmaceutical CDMOs? With the global pharma industry growing at a fast pace, big pharmaceutical companies are continuing to focus on their core business. With their promise of decreasing time to market and reducing costs, contract development and manufacturing organizations (CDMOs) have positioned themselves as alternatives to in-house development and manufacturing operations. The pharma companies are also seizing at this opportunity to outsource drug development to the CDMOs. The majority of formulations that pharma companies continue to outsource to CDMOs are solid dosage forms. Contract Development and Manufacturing Organizations (CDMOs) offer their clients comprehensive services from drug development to manufacturing. The CDMOs offer integral services that include projects from external third parties and make use of their knowledge, development and manufacturing capabilities. With preformulation, formulation development services, clinical trials and commercial manufacturing, CDMO such as Mikart can start with a concept or a ready-to-use formula.  CDMO companies offer services such as formulation, analytical services, blending, coating, converting, packaging, serialization and shipment. Full-service pharmaceutical contract development and manufacturing organization (full-service CDMO) such as Mikart can manage every aspect of formulation development and manufacturing. CDMOs will have several opportunities to grow in the near future. Big pharmaceutical companies are embracing outsourcing services as a strategic method to speed up their drug development timelines. Q. What are the benefits that contract development and manufacturing organizations offer to pharmaceutical companies? Formulation development and manufacturing is a complex process, and partnering with the right pharmaceutical CDMO (contract development and manufacturing organization) will help pharma companies through all stages of drug development and formulation. Pharmaceutical companies are relying more and more on contract development and manufacturing organizations (CDMOs) for different complex and novel formulation development and manufacturing. Outsourcing has become a market trend across the pharmaceutical manufacturing landscape. By choosing the right CDMO partner, pharma companies can avert delays and pitfalls. Contract development and manufacturing organizations (CDMOs) provide several benefits to pharmaceutical companies, such as: Technical Expertise : Pharma CDMOs have the technical expertise and technological and operational know-how to meet the needs of formulation development projects. Finding a CDMO with the right experience in different formulation technologies can also help a company to develop and manufacture a number of drug products. Many CDMOs can even provide nanotechnology, which is needed to solve some difficult formulation challenges. Experience : Experience is the most important factor in determining whether a manufacturing partner is capable of delivering the quality and scale required to ensure the success of a project. Full-service CDMOs and CMOs have a remarkable depth of experience and specialization in drug product development and manufacturing. CDMOs assess a compound's physical and chemical properties, evaluate the drug and its intended target site and recognize the drug's uptake. Quality : Quality should always be the most important factor one should consider while selecting a pharmaceutical contract development and manufacturing organization. CDMO such as Mikart are relatively economical and provide better quality products in higher quantities, at a faster rate and at lower costs. The focus of a pharmaceutical CDMO is always on pricing and factors that contribute to high quality, such as drug product manufacturing capacity, experience, reputation, technical competency, etc. Manufacturing Facilities : Outsourcing services to a contract development and manufacturing organization gives companies access to a larger number of equipment and facilities. There are various pharmaceutical companies that rely on outsourced facilities. This has provided the CDMO market the chance to grow and pharma companies the opportunity to avoid expenses associated with purchasing specialized equipment. For instance, If you are looking for the production of complex injectables, you should choose a CDMO that has equipment scale and material handling expertise with the preferred product batch size. Facilities should be assessed for class 100 clean room suites, laminar flow hoods, biosafety cabinets, etc. In addition, the CDMO must follow current good manufacturing practices (cGMP), which is necessary for compliance with regulatory guidelines. Speed : CDMOs generally offer better quality products in higher quantities, faster and at lower costs. A CDMO's value proposition to customers includes speed as a major aspect, and the key to optimized scalability is to maintain the correct pace for the exact product and quantity. Scalability : CDMOs are well known for their ability to provide scale-up for pharmaceutical companies. Due to their ability to scale up production without adding expenses of labor, facility space, etc, CDMOs and CMOs  help pharma companies in meeting production deadlines. Cost-Effectiveness : Pharmaceutical CDMOs not only help companies to meet deadlines and scale up faster, but they also reduce infrastructure costs by lowering or removing the need for additional production. To control expenses, CDMOs should be used to influence procedure methodical testing counting in-machine inspections, verifications and non-destructive testing. The knowledge of an experienced CMO / CDMO partner and their advanced technologies often helps pharma companies in controlling costs during early stage drug development, while working on a very aggressive but realistic timeline. Q. What are the different CDMO services offered by Mikart? Mikart's more than 45 years of experience in oral solid and non sterile oral liquid dosage forms as well as its specialization in pediatric, geriatric and controlled substances, make it an ideal contract development and manufacturing organization partner from formulation development through commercialization. Mikart is a contract development and manufacturing organization (CDMO) that offers a full range of services for drug development and commercialization. Mikart has a number of capabilities including pharmaceutical drug development, clinical trial supplies, regulatory services, solid and liquid oral dosage form manufacturing, packaging and analytical services. Since its formation over 45 years ago, Mikart has been delivering the highest quality products, exceeding the most demanding client standards, regardless of where you are in the process, from conceptualization to maximizing market adoption. The Mikart experience is distinguished by transparency, reliability and responsiveness, which serve as the foundation for expert, flexible solutions to advance your products. From formulation through full-scale commercialization, Mikart has proven expertise in oral solids (tablets and capsules) and non-sterile oral liquid dosage forms with a focus in pediatrics, geriatrics and controlled substances. Mikart delivers the high-quality services that you require, along with the speed and responsiveness that you want. As a contract development and manufacturing organization (CDMO), it offers a comprehensive suite of integrated services and technologies, and supports the development, manufacturing and packaging of oral solids and non-sterile liquid dosage forms. The various services offered by Mikart are as follows: - Analytical method development - Preformulation - Formulation development [Fast dissolve (ODT), modified release, multiple-unit pellet system, oral solutions, oral suspensions, powder for oral solutions and film-coated tablets] - Scale-up - Site and technology transfer - Packaging - Regulatory support Mikart provides pharmaceutical manufacturing services for clinical trial materials, physician samples and commercial products.  

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December, 2022
Overview of PMC Isochem`s polyamino acid (PAA) based polymers, polymer conjugates, polypeptides, polyamides for drug delivery on PharmaCompass.
 Overview of PMC Isochem's polyamino acid (PAA) based polymers, polymer conjugates, polypeptides, polyamides for drug delivery on PharmaCompass.What are polyamino acids and PAA-based drug delivery systems?A polyamino acid, sometimes also called a polypeptide, is a synthetic biopolymer made from amino acid monomeric units. Polyamino acids (PAAs) are comparable to proteins (and peptides) as they are also composed of amino acid building blocks linked by means of amide bonds. Structural and functional proteins, polypeptides, peptides and polymers derived from amino acids are called polyamino acids. Polyamino acids have several biological applications in tissue engineering, regenerative medicines and drug delivery systems, etc.Additionally, polyamino acids are endowed with remarkable biological functionalities, such as a target-specific delivery and rapid metabolization of their degraded products. The hydrophilicity of the amino acids influence the degradation rates of polyamino acids. The most important polyamide homo- and copolymers that are widely used in drug delivery are poly(amidoamine), polylysine, polyaspartic acid and poly(glutamic acid). Novel polymer-based drug delivery systems are being developed to change the physicochemical and pharmacokinetic characteristics of drug molecules for controlled delivery. The capability to enable unique and highly-targeted biological functions make proteins and peptides ideal candidates for drug delivery systems. The advantages of using Polyamino acids or polyamide polymer as a drug delivery system include localized target-specific delivery, biocompatibility, biodegradability, flexible physicochemical modification, slow degradability, sustained release and stabilization. Polyamino acids are widely utilized in the formulation of chemotherapeutics to achieve selective drug delivery for the right amount of time, which will reduce drug-related adverse effects and boost anti-tumor efficacy. What are the applications of polyamino acids based delivery?Poly(amino acid)s are the most commonly used polyamides in drug delivery. The use of peptides as carriers of nucleic acids for controlled delivery into target cells and organelles is one significant application of such functional materials. There are various other applications of polyamino acids which are as follows:- Poly(amino acid)s are utilized in a variety of medical and biological applications including cell adhesion, drug delivery, gene therapy, diagnostic, oncology, antibacterial, antifungal and surface chemistry.- Polyamino acids-based delivery systems have highly attractive material properties such as biodegradability, non-cytotoxicity, and mechanically durability. Natural polyamino acid (PAA) has been widely utilized in the controlled delivery of drug, protein and gene because of its excellent biocompatibility.- Polyamino acid based delivery is frequently utilized in targeted drug delivery and controlled drug delivery. Polyamino acids deliver a therapeutic to a targeted area through site-specific interactions, exploit transmembrane transport systems and deliver a therapeutic payload to a targeted site, devoid of side effects.- Water-soluble drug-polymer conjugates offer benefits such as enhanced drug pharmacokinetics and pharmacodynamics, minimal toxicity to essential organs, non-immunogenicity, tissues or cells and improved drug buildup at the target site to enhance targeted drug delivery via carrier-based systems. - Poly(amino acid)s are the first class of biomaterials and have biomedical applications because of which they are used as nonviral gene delivery vectors. Therefore, the design and synthesis of polyamino acid vectors are of great interest.- Microscale carrier is an important component of the drug delivery system that enables it to be well designed for enhancing the pharmacological and therapeutic features of drug administration.- Poly(amino acid)/polypeptide as functional materials have a variety of features like stimuli-responsive, self-assembling, nano-scale and self-healing- Silk is a structural protein that exhibits properties of self-assembly, mechanical toughness, processing flexibility, biodegradability & biocompatibility, making it extremely useful for several human therapeutic interventions.What are the different methods of synthesis of polyamino acids?In the field of sustainable chemistry and materials engineering, there is a growing interest in the development of an engineered biopolymer, such as a biomass-derived polyamide. Materials made of polyamino acids (PAAs) have attracted a lot of attention in the field of biomedicine because of their exceptional biocompatibility and biodegradability. Current synthesis techniques that are used to synthesize a biopolymer like a polypeptide and polyamino acid, such as solid-phase peptide synthesis and recombinant DNA techniques, still have problems with their production capacity, atom economy and sequence regulation. It is important to closely regulate the molecular weight within a narrow range when synthesizing polyamino acids (PAAs) for drug delivery and biomedical applications. Polypeptides are derived from the ring-opening polymerization of alpha-amino acid N-carboxyanhydrides (NCAs). Chemo-enzymatic synthesis can be used for the synthesis of polyamino acids. It is one possible option for the efficient synthesis of poly(amino acid)s, regarding yield, reaction time and atom economy.The production of polypeptides using the ring opening polymerization of amino acid N-Carboxyahydride monomers results in limited polydispersity, little side product formation, high reproducibility, flexible architectures and precise functionalization of the polypeptide backbone.Polymers based on amino acid monomers have attracted a lot of attention in drug delivery. As the manufacturing of PAA or polyamides involves numerous challenges, many companies prefer to outsource their needs. There are several  CDMOs for polyamino acids offering custom synthesis and manufacturing for GMP Polymers and copolymers based on various polyamino acids like Poly-L-Lysine, Poly-L-Glutamic acid, Polysarcosine, etc. What are the polyamino acid based polymer manufacturing services offered by PMC Isochem?A contract development and manufacturing organization (CDMO), PMC Isochem provides amino acid based polymer diversity for drug delivery and innovative treatments. From R&D to GMP large-scale production, PMC Isochem offers polypeptide excipients and drug-polymer conjugates along with GMP polymers and copolymers based on various polyamino acids like Poly-L-Lysine, Poly-L-Glutamic acid, Polysarcosine, etc.Polyamino acid based delivery is a major area of interest for advanced biomedicines because of its biocompatibility and biodegradability. The chemical & architectural versatility of polyamino acids & polypeptides is enormous. Polyamide acids are utilized in several therapeutic areas, including immunotherapy, oncology, gene therapy, inflammatory, neurodegenerative, infectious, diagnosis, skin care, etc. Synthetic GMP polyamino acids are being used in biomedical and drug delivery applications as they are structurally similar to naturally occurring proteins. Drug–polymer conjugates offer improved pharmacokinetic and properties with enhanced stability for targeted drug delivery. PMC Isochem is a CDMO for polyamino acids integrated in strategic monomers NCA (α-aminoacid N-CarboxyAnhydride) offeringStandard and customized GMP polyamino acidsDevelopment and characterizationScale-up and clinical supply Commercial manufacturingPMC Isochem has 40 years experience in large-scale GMP custom manufacturing  of polyamino acids (PAA) from kilolab to full-scale production. It has 3 production sites in France and has manufacturing facilities audited by the US & EU regulatory agencies. PMC Isochem is a widely known CDMO for polyamino acids. It provides custom-made Polyamino acid (PAA) design for its clients, which is supported by integrated NCA supply and development for GMP polymers and copolymers based on different polyamino acids like Poly-L-Lysine, Poly-L-Glutamic acid, Polysarcosine, etc. PMC Isochem has a highly skilled and diversified R&D team with academic affiliations. It has fully equipped infrastructures and a network for accessing cutting-edge technologies for polyamino acid based delivery. PMC Isochem has a lean approach to provide cheaper, faster and better solutions, which allows its clients to save cost, time and risk. To help its customers grow their businesses, PMC Isochem has a flexible and creative business development team with IP portfolio and proprietary GMP polyamino acid (PAA) systems.

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December, 2022
Overview of peptide development & contract manufacturing services & more on CBL`s CDMO & CMO services for non-GMP & cGMP peptides on PharmaCompass.
Overview of peptide development & contract manufacturing services & more on CBL's CDMO & CMO services for non-GMP & cGMP peptides on PharmaCompass. What are peptides? A peptide is a short chain of two or more amino acids that are connected to one another by an amide-type of covalent chemical bond. Amino acids are the building blocks of proteins and peptides are distinguished from proteins by their shorter length. Peptides can act as growth factors, neurotransmitters, ion channel ligands, anti-infectives, hormones, etc. Several pharmaceutical and cosmetic products use different peptides for their potential anti-aging, anti-inflammatory, fat-burning and muscle-building properties. Synthetic therapeutic peptide APIs have several important applications in biochemistry, molecular biology, immunology and medicine. Peptide manufacturing has changed considerably over time and has led to innovative techniques for peptide API production. There are more than 80 peptide-based drugs currently available in the market that are used to treat conditions like cancer, chronic pain, diabetes, osteoporosis, HIV infection and multiple sclerosis. Hence, the demand for peptide-based therapeutics is increasing at a considerable pace. Peptide active pharmaceutical ingredients (APIs) are highly selective. They have high specificity, affinity, less drug-drug interactions, diverse biological and chemical activities and are effective at lower doses, thus reducing toxicity levels. Peptides may be easier for the body to absorb than proteins. Peptides enter the bloodstream more quickly as they can easily pass through the skin and intestines. Peptides are a complex class of drugs and have proven to be a challenge from the manufacturing point of view. Peptides with shorter lengths (up to 10 amino acids) are manufactured by liquid phase peptide synthesis. Segment condensation and ligation techniques are used for longer peptides (up to 120 amino acids). There are several pharmaceutical contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) that offer custom peptide production, GMP contract peptide manufacturing, custom peptides development and synthetic peptide API manufacturing. What are the different approaches for synthesis of peptides? Peptides are produced using various methods such as solid phase peptide synthesis (SPPS), liquid-phase peptide synthesis, hybrid solid/solution phase synthesis, fragment condensation and other novel technologies. Solid- and liquid-phase synthesis are the most commonly used methods for peptide API manufacturing. - LPPS : Liquid-phase peptide synthesis Liquid-phase peptide synthesis is a classical approach to custom peptide synthesis and is used to produce peptides on a large scale for industrial purposes. Early peptide synthesis was carried out in solution and required careful manipulation of protecting groups and multiple challenging workups and isolations. The liquid-phase approach is used to synthesize short peptides such as di- and tripeptides, along with C-terminally modified peptides such as enzyme substrates. Liquid phase peptide synthesis, on the other hand, can be advantageous as the quantities of products increase. This methodology can be problematic for the synthesis of longer and more complex peptides, but it works well for shorter peptides and fragments. - SPPS : Solid-phase Peptide Synthesis Peptide synthesis became a more practical part of contemporary scientific research following the advent of solid-phase techniques. Solid-phase peptide synthesis (SPPS) is the recommended technique for chemical peptide synthesis, which enables routine synthesis of any type of peptide sequence, including complex or cyclic custom peptides. Synthetic therapeutic peptide APIs can be synthesized automatically using solid phase peptide synthesis (SPPS). It entails adding protected amino acids in stages to a growing peptide chain joined to a solid-state resin particle by a covalent bond. It is the essence of solid-phase technique where reactions are driven to completion by the use of extra soluble reagents, which can be eliminated by simple filtration and washing without manipulative losses. However, SPPS is far from perfect, especially in terms of greenness. SPPS has been widely adapted in the pharmaceutical sector because it can be automated and is scalable, and it is now being used to produce a range of marketed peptide-based drugs. The advantages of solid phase peptide synthesis (SPPS) include easy purification, shorter process development, higher cost efficiency, rapid generation of linear peptide intermediates and the availability of fully automated production techniques. It can also be competitive in large-scale processes and is used to produce longer sequences and complex peptide API (active pharmaceutical ingredient). Synthetic peptide API manufacturing, complex peptide synthesis and purification present a number of challenges, including complexities associated with long chain macromolecules, which are known to have an impact on product yield and purity. Currently, various peptide CDMOs (contract development and manufacturing organizations) offer services for the clinical development and GMP contract peptide manufacturing. Why do pharmaceutical companies need CDMOs for the development and manufacturing of peptides? The interest of pharmaceutical companies in peptide drugs have continued to grow over the last two decades, and drugmakers are now turning to peptide contract manufacturers for the production of these drugs. The contract development and manufacturing organization (CDMO) sector is now considered a vital source of peptide drug development and manufacturing services, from clinical development to commercial manufacturing. As the market for cancer, diabetes, HIV infection, multiple sclerosis drugs continues to grow at a healthy pace, pharmaceutical companies are increasingly looking for more assistance from contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) with proven track records for the safe production of synthetic therapeutic peptide APIs.  - Full-service CDMOs possess a remarkable depth of experience and specialization in the development and manufacturing of APIs. CDMOs help to meet production deadlines by allowing manufacturers to change production volume, add a drug variation or scale up without incurring additional expenses for labor, facility space, etc. - Outsourcing services to a contract development and manufacturing organization gives companies access to a larger number of equipment and facilities for the production of complex peptide active pharmaceutical ingredients. - For GMP contract peptide manufacturing, pharmaceutical companies are increasingly looking for Contract Development & Manufacturing Organizations (CDMOs) that can provide a pathway from research and pilot labs all the way through commercial manufacturing, depending on the requirement. - Large pharmaceutical companies are increasingly relying on outsourced facilities to provide the CDMO market the opportunity to flourish and eliminate expenses associated with purchasing specialized equipment, as CDMOs have access to both equipment and facilities. - Pharmaceutical CDMOs not only help companies in meeting deadlines and scaling up faster for peptide APIs, but they also reduce infrastructure costs by reducing or eliminating the requirement for additional production. - Pharmaceutical CDMOs and CMOs are highly competitive, constantly striving to produce better quality products in higher quantities, faster, and at cheaper rates. Due to increasing complexities of peptide APIs, pharma companies have become more dependent on outsourcing services. What are the different factors one should consider while selecting a peptide contract manufacturer? Before choosing a contract peptide API manufacturing or custom peptide synthesis partner for your peptide drug candidate, make sure about their regulatory capabilities, scale-up synthetic peptide API manufacturing versatility. Here are a few factors that you should consider while selecting a peptide contract manufacturer for your peptide active pharmaceutical ingredients (APIs): - When you are choosing a CDMO partner for contract peptide API manufacturing, the first thing you need to do is to make sure that the CDMO has the technical expertise and experience to handle your peptide-based products. - Visit the CDMO's facilities and evaluate the equipment and procedures for the manufacturing of peptide active pharmaceutical ingredients (APIs). - Make sure that the CDMO you are choosing for contract peptide API manufacturing is offering the flexibility, collaboration and innovation that you require for Peptide Active Pharmaceutical Ingredients (APIs). - Quality should always be the most important factor to be considered while selecting a peptide CDMO (contract development and manufacturing organization). - Peptide CDMO partners should be selected on the basis of their compatibility with your marketing plans at each stage of the lifecycle of your product. If the final market for your product is the US, make sure that the peptide contract manufacturer is FDA inspected. What pharmaceutical peptide manufacturing services does CBL offer? There has been a revival of peptide APIs in recent years as the pharma industry has once again turned its focus towards the potential of therapeutic peptides. Peptide drug development is a complex process. Partnering with the right pharmaceutical contract development and manufacturing organization (CDMO) makes it easier to meet deadlines and scale up faster, while also saving money and time.  One of the largest peptide material suppliers in the world, CBL Patras offers peptide starting materials, peptide intermediates, along with industrial and commercial-scale manufacturing of proprietary and generic GMP and non-GMP peptides. CBL develops partnerships that grow from the laboratory scale to commercial production by using its facilities that can accommodate programs from the gram to ton range. CBL is a leading manufacturer and developer of innovative reagents for custom peptide synthesis. A catalog of more than 400 compounds are available for solid-phase organic and peptide synthesis. CBL is specialized in the production of pharmaceutical peptides from clinical development to commercial manufacturing. When it comes to outsourcing peptide manufacturing or custom peptide production, CBL will work with your company to provide affordable and time-efficient contract services. CBL has four laboratory and manufacturing buildings spread over 10,000 square meters. Its highly automated, efficient facilities enable CBL to operate from the gram to ton scale, both for solid phase synthesis as well as solution phase synthesis. CBL's state-of-the-art equipment and facilities have been built specifically for custom peptide synthesis, setting new benchmarks for GMP custom peptide development on both small and large scales.

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December, 2022
Overview of PMC Isochem`s Vitamin E TPGS (Tocophersolan), a multirole excipient for pharmaceutical drug delivery, on PharmaCompass.
Overview of PMC Isochem's Vitamin E TPGS (Tocophersolan), a multirole excipient for pharmaceutical drug delivery, on PharmaCompass.What is Vitamin E TPGS?Vitamin E TPGS is a multirole excipient for pharmaceutical drug delivery and is a water soluble derivative of natural Vitamin E. Vitamin E TPGS is chemically known as d-alpha-tocopheryl polyethylene glycol succinate or TPGS. It is formed along with polyethylene glycol 1000 by esterification of d-alpha-tocopheryl polyethylene glycol succinate.Vitamin E has been linked to various other functions, including antioxidant, anti-thrombolytic and other therapeutic effects. d-alpha-tocopheryl polyethylene glycol succinate (TPGS) has various interesting properties that can help innovators to address drug delivery challenges. Vitamin E TPGS-based formulations can be administered through the oral, mucosal, nasal, parenteral, ophthalmics and dermal routes. These formulations are used as nutrition supplements or dietary supplements.Vitamin E TPGS is used in various drug formulations such as tablets, capsules (hard and soft), solutions, creams, nanocrystals, nanosuspensions, solid dispersions, adjuvants in vaccine systems, self-emulsifying/micro emulsifying drug delivery systems (SEDDS/SMEDDS) and lipid based formulations including solid lipid nanoparticles (SLNs).TPGS, also known as Tocophersolan (Tocofersolan) has gained a lot of attention as a versatile excipient in different biomedical applications including drug delivery systems and nutraceuticals. A molecular biomaterial, it exhibits excellent drug delivery capability that is based on its special amphiphilic structure. where each molecule consists of hydrophilic and lipophilic moieties.Vitamin E TPGS or Tocophersolan is widely used to improve the bioavailability of several active pharmaceutical ingredients. It is also used as a molecular biomaterial for drug delivery and absorption enhancer as well as a permeation enhancer in various pharmaceutical drug delivery systems.Furthermore, Vitamin E TPGS-based formulations can also be used in a variety of applications, such as dietary supplements, nutraceuticals, food & beverage, cosmetic & personal care and animal nutrition. In fact, these markets, too, require innovative solutions and could benefit from TPGS’ unique properties.What are the different properties of Vitamin E TPGS?Vitamin E PEG-1000-succinate (Tocophersolan) is a unique and pleiotropic polymer that is a polymeric, synthetic version of vitamin E.Vitamin E TPGS, also known as tocopheryl polyethylene glycol succinate, is a white to light tan water-soluble waxy solid with low melting point that is chemically stable to heat, oxygen and light.Vitamin E PEG-1000-succinate is a non-ionic surfactant that is a water soluble derivative of natural Vitamin E. As a novel non-ionic surfactant, Vitamin E TPGS is a macromolecule comprising a lipophilic alkyl tail and a hydrophilic polar head with amphiphilic properties. It can form stable micelles in aqueous vehicles at concentrations as low as 0.02 wt%.Tocophersolan can also act as a P-glycoprotein (P-gp) inhibitor. It is used as an excipient to treat multidrug resistance (MDR) and to improve the oral bioavailability of many anticancer drugs.Additionally, d-alpha-tocopheryl polyethylene glycol succinate (TPGS) exhibits antioxidant effects. making it a popular component in cosmetics and pharmaceuticals.Tocofersolan can be used as an excellent drug solubilizer and emulsifier.Since the Food and Drug Administration (FDA) approved Vitamin E PEG-1000-succinate as a safe pharmaceutical adjuvant, many TPGS-based drug delivery systems (DDS) have been developed.Vitamin E TPGS-based formulations can be administered through the oral, mucosal, nasal, parenteral, ophthalmics and dermal routes.What are the applications of Vitamin E TPGS in the pharmaceutical industry?For several years, Vitamin E TPGS has been administered orally, but many new delivery applications such as parenteral, nasal, ophthalmic and dermal deliveries have also been investigated. Since it was approved by FDA as a safe pharmaceutical adjuvant, TPGS has been widely used as a molecular biomaterial for drug delivery, surfactant, drug solubilizer, a stabilizer in various drug delivery systems and a P-gp inhibitor for enhancing bioavailability and reversing MDR.The applications of Vitamin E TPGS are noted below:     Vitamin E TPGS is used as an emulsifier, a vehicle for lipid based formulations and an active ingredient in self-emulsifying formulations (SEDDS & SMEDDS). Apart from this, it has been exclusively investigated for its dispersing, gelling and solubilizing properties.     As the hydrophobic portion can trap hydrophobic drugs and the formulations can be stabilized by the hydrophilic portion, TPGS or tocopheryl polyethylene glycol succinate can be used as a surface stabilizer for drug formulations.     Vitamin E TPGS is used as a permeation enhancer and bioavailability enhancer of hydrophobic drugs, a plasticizer for hot melt extrusion and a stabilizer for amorphous solid dispersion.     TPGS has surfactant properties that improve the solubilization of drugs that are poorly water soluble. As a result, Vitamin E TPGS is used in drug delivery as a drug solubilizer, an absorption enhancer and a permeation enhancer.     Tocofersolan-based drug formulations have numerous advantages for improving the bioavailability of oral dosage forms.     Vitamin E TPGS is used as a nutrition supplement, dietary supplement, plasticizer of film, anticancer reagent, etc.     The biological and physicochemical properties of TPGS offer several advantages for drug delivery applications, including high biocompatibility.     TPGS inhibits the efflux of P-glycoprotein that improves drug permeability.     Tocofersolan (tocopheryl polyethylene glycol succinate) is widely used in the fabrication of nanodrugs or other formulations for many poorly water-soluble or permeable drugs, particularly for biopharmaceutics classification system (BCS) class II and IV drugs with poor water solubility or permeability.     Vit E TPGS is used as a stabilizer for amorphous drug forms.     TPGS-based polymers are widely used in the drug delivery system, where they can improve the drug’s encapsulation efficiency, intracellular cell uptake and therapeutic efficacy in vitro and in vivo.What are the Vitamin E TPGS manufacturing services that PMC Isochem offers?PMC Isochem is a custom development & manufacturing organization that provides cGMP intermediates, active pharmaceutical ingredients (APIs), excipients and polymers for pharmaceutical drug delivery solutions.It offers Vitamin E TPGS, a water soluble derivative of natural Vitamin E that serves as a multirole excipient in pharmaceutical drug delivery innovation. Vit E TPGS has been used primarily in oral dosage forms for many years, but new delivery methods such as parenteral, nasal, ophthalmic and dermal are being investigated.Vitamin E TPGS functions as a solubilizer of poorly water soluble drugs, an absorption enhancer, a permeation enhancer by inhibiting P-glycoprotein efflux, a stabilizer of amorphous drug dispersion and a functional ingredient in lipid-based formulations and molecular biomaterial for drug delivery. In melt granulation/extrusion processing, it also acts as a thermal binder.PMC Isochem vitamin E TPGS is made by esterification of the carboxylic group of crystalline d-alpha-tocopheryl succinate with polyethylene glycol 1000. The manufacturing process has been thoroughly validated. In order to secure its supply chain, PMC Isochem has multi-sourced approvals of key raw materials that comply with Pharmacopoeia.PMC Isochem Vit E TPGS is produced in France in state-of-the-art FDA-audited cGMP facilities. French drug authority, ANSM (Agence Nationale de Sécurité du Médicament), has granted a certificate of GMP compliance for the production of Vitamin E TPGS to PMC Isochem.For the past ten years, PMC Isochem has been producing GMP USP/NF compliant ISODEL® Vitamin E TPGS. PMC Isochem has a DMF Type II for the production of active pharmaceutical ingredients (APIs). PMC Isochem has a steady supply of ISODEL™ Vitamin E TPGS, with manufacturing capacity spread across two GMP FDA-audited facilities.PMC Isochem offers ISODEL™  TPGS analogues with polyethylene glycol chain molecular weights of 200, 300, 400, 1,500, 2,000 and 4,000 g/mol. Standard TPGS has a polyethylene glycol molecular weight of 1,000 g/mol.

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October, 2022
Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API`s CDMO services for cytotoxic HPAPIs on PharmaCompass.
Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.Q1. What is a highly potent API (HPAPI)?Highly potent active pharmaceutical ingredient (HPAPI) is a compound that elicits a biological response at a much smaller dose, such as a daily therapeutic dose of <10 mg. High potency drugs have the ability to bind selectively at low doses to specific receptors or inhibit specific enzymes as part of cancer or hormonal therapies.High-potency APIs (HPAPIs) require multi-step processes or semi-synthesis along with special handling requirements due to toxicity. HPAPI development and production require specialized considerations in facility design, equipment, operation and process safety to achieve the requisite level of containment. It also presents major handling challenges for innovators and manufacturing companies.High-potency APIs (HPAPIs) are becoming increasingly popular and companies are now looking for flexible containment solutions to help address their needs. However, if the current HPAPI development continues to show more efficacy, high potent API is likely to become one of the most dominant areas in the industry. High potency API (HPAPI) is prominent in oncology research and hence represents an increasingly significant share of the pharmaceutical drug pipeline.Because a growing number of pharmaceutical products contain highly potent active pharmaceutical ingredients (HPAPI) , demand for the production of HPAPIs has increased. Estimates suggest the global HPAPI market will register a strong growth over the next 5-10 years. In addition to cancer, highly potent API (HPAPI) is being used in hormonal imbalance drugs, cardiovascular drugs, central nervous system drugs and musculoskeletal drugs.The challenges in HPAPI manufacturing have also increased, along with investment