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Overview of CDMO Services of EUROAPI, such as small molecule APIs, peptides, microbial fermentation, micronization & spray drying on PharmaCompass.
Q1. What is a CDMO? What are the different types of pharmaceutical CDMO Services?
A contract development and manufacturing organization (CDMO) is a company within the pharmaceutical industry which provides drug development and manufacturing services. Drug molecules are becoming more complex, necessitating both advanced synthesis and formulation expertise. That's why the outsourcing of drug product development and manufacturing to contract suppliers has become the preferred go-to-market strategy for many of the industry's leading drug developers.
Pharmaceutical manufacturers are relying on contract development and manufacturing organizations (CDMOs) to receive access to specialized expertise, control costs and considerably speed up the successful development and commercialization of pharmaceutical products. When partnering with a full-service CDMO, a pharmaceutical company can start with little more than a concept or idea and be guided all the way from preformulation and formulation development through clinical trials and commercial production.
Several trends in the pharmaceutical industry are driving drug manufacturers to outsource more tasks, from discovery to research to commercial production and even life cycle management. Pharmaceutical companies, including specialty and orphan-drug firms, have opportunities to enter the global market in partnership with pharma CDMOs. Full-service pharmaceutical contract development and manufacturing organizations (full-service CDMOs) can handle every aspect of drug development and drug manufacturing, as well as work with clients who want to outsource specific aspects of their process as per the requirement.
Some of the pharma CDMO services includes:
- API Development
- Preformulation
- Formulation Development
- API & Drug Product Manufacturing
- Analytical Services
- Packaging & Serialization
- Shipment
CDMOs (contract development and manufacturing organizations) will have several opportunities to grow in the near future. Big pharma companies are embracing outsourcing services as a strategic method to speed up their drug development timelines. For biotechnology firms, pharma CDMOs are increasingly being viewed as extensions of their pharmaceutical development and manufacturing departments.
Q2. Why do pharmaceutical companies need CDMOs?
Drug development is a complex process, and partnering with the right pharmaceutical contract development and manufacturing organization (CDMO) not only helps meet deadlines and scale up fast, but also saves money and time. Pharmaceutical outsourcing helps provide support to companies through all stages of drug development and formulation and for all types of drug substances.
Pharmaceutical companies have begun to rely more on contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) for the development and manufacturing of new drugs in the last decade. These companies provide numerous benefits to the pharmaceutical companies, such as:
Technical Expertise and Experience - Pharma CDMOs have the technical expertise and operational experience to meet the needs of drug development projects and reduce expenses. Full-service CDMOs have a remarkable depth of experience and specialization.
Equipment - Equipment is another area where leading CDMOs are investing. With internal drug development and manufacturing services, pharmaceutical companies face a difficult decision when they want to increase capabilities. Outsourcing services to a contract development and manufacturing organization, on the other hand, gives companies access to a larger number of equipment and facilities.
Development & Manufacturing Facilities - Large pharmaceutical companies rely on outsourced facilities as well as the inability of smaller companies to have in-house production sites have provided the CDMO market the opportunity to flourish and eliminate expenses associated with purchasing specialized equipment, as CDMOs have access to both equipment and facilities.For example, as the market for cancer drugs continues to grow at a healthy pace, pharmaceutical companies are seeking more assistance from contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) with established track records for the safe production of highly potent active pharmaceutical ingredients (HPAPIs).
Scale-up Capabilities - Pharmaceutical CDMOs help to meet production deadlines by allowing manufacturers to shift production volume, add a drug variation or scale up without adding expenses of labor, facility space, etc. CDMOs are well-known for their ability to provide scale-up for pharmaceutical companies. Outsourcing pharmaceutical development and manufacturing enables businesses of all sizes to grow.
Cost-effectiveness - Pharmaceutical CDMOs not only help companies to meet deadlines and scale up faster, but they also reduce infrastructure costs by lowering or eliminating the need for additional production and drug manufacturing.
Benefits of end-to-end pharma CDMO business models - Although commercialization routes for drugs and therapeutic compounds are relatively well mapped, the drug development and manufacturing process will always require experienced navigation abilities to anticipate challenges. Pharmaceutical CDMOs and CMOs are highly competitive, constantly striving to produce better quality products in higher quantities, faster and at cheaper rates. Pharma companies have become more reliant on outsourcing services due to the growth of small molecules and increasing API complexities.
Q3. How to choose the right CDMO partner?
With the number of complex and highly potent active pharmaceutical ingredients (HPAPIs) increasing, contract development and manufacturing organizations (CDMOs) need to make themselves stand out through the use of advanced technology and specialized expertise. Modern CDMOs must be agile and flexible to find solutions that boost efficiency. Over the last two decades, the CDMO sector has advanced by leaps and bounds and is now considered a vital source of drug development and manufacturing services.
While searching for the right contract development and manufacturing organization (CDMO) to fit your needs, you should carefully evaluate them and ensure that the CDMO you shortlist can provide you with the right package.
- When it comes to choosing a CDMO partner, the first thing you need to do is to make sure that it has the technical expertise and experience to handle your products.
- Take a tour of the facilities and evaluate the equipment and procedures. For instance, If you are looking for a contract development and manufacturing organization (CDMO) to handle complex parenteral formulations, you need to make sure that the CDMO has material handling expertise, along with sufficient equipment, class 100 clean room suites, laminar flow hoods, biosafety cabinets, isolators and restricted access barrier systems (RABs).
- The CDMO must be experienced in the field that you are looking for and that it can formulate specific molecules to meet your requirements. The CDMO must be able to assess the API's properties, evaluate the drug and its intended target site. You need to be sure that the CDMO is offering the flexibility, collaboration and innovation that you require.
- Quality should always be the most important factor you should consider while selecting a pharmaceutical contract development and manufacturing organization (CDMO). The attention of a pharmaceutical CDMO should be on pricing and factors that contribute to high quality, such as drug manufacturing capacity, experience, reputation, technical competency, etc.
- Be sure to keep costs and timelines in check for all phases, from drug development to drug manufacturing. Request your CDMO partner for a complete breakdown of costing, including the cost of different batch sizes.
Q4. What are the different CDMO services offered by EUROAPI?
As drug substances become increasingly complex, pharmaceutical companies are facing many challenges developing and manufacturing drug substances. The pharmaceutical contract development and manufacturing organization (CDMO) sector is quickly responding to the challenges within the pharmaceutical industry. There is now a greater need for rapid innovation and the production of more effective process solutions to quickly deliver outstanding drug development and manufacturing services.
EUROAPI is a world leader in active pharmaceutical ingredients (APIs) with over 200 products in its portfolio. It offers a large number of technologies, while developing innovative molecules through its pharmaceutical contract development and manufacturing organization (CDMO). It is the leading small molecules API player with a unique European industrial platform and a proven track record for reliability.
Based on Sanofi's 15 years of experience in the field of oligonucleotides and 45 years in the field of peptides, EUROAPI provides a unique state-of-the-art platform for their development and scale-up at Hoechst Industrial Park in Frankfurt (Germany). Both API solutions and contract development and manufacturing organization (CDMO) services are covered by EUROAPI.
For its global healthcare partners, EUROAPI develops, manufactures and supplies active pharmaceutical ingredients. EUROAPI encompasses the entire range of development activities, from clinical development phase to submission and launch, as well as regulatory support and commercial production. The Frankfurt facility is a pioneer in solid-phase synthesis. It is regularly inspected by the FDA, as well as by other European and international agencies.
Various CDMO Services offered by EUROAPI are noted below:
Small molecule synthesis
EUROAPI is able to build on a unique heritage in API development and organic synthesis by combining the chemical expertise of Hoechst-Aventis, Roussel-Uclaf, Chinoin, Genzyme and Sanofi. Over 250 scientists work at its six commercial facilities that offer 2,000 m³ cGMP for organic synthesis and 6,000 m³ for microbial fermentation to produce small molecules. It has an experienced R&D team with proven experience on multi-ton small molecule APIs and intermediates.
Microbial Fermentation
EUROAPI is a leading global provider of high-quality custom microbial process development and manufacturing for pharma companies. From proteins and enzymes to yeasts and actinomycetes, its expertise spans a spectrum of GMO and non-GMO microorganisms procured in its 6,000 m³ microbial fermentation capacity at its facilities in France and Italy.
Particle Engineering
EUROAPI is an expert in particle engineering, with expertise in two key technologies: micronization (for development and commercial-scale operations, inhalables and nanoparticles) and spray drying (for development to large commercial-scale output). The EUROAPI Vertolaye plant in France is its Center of Excellence for particle engineering - micronization.
Spray Drying
In the food and pharmaceutical industries, the spray drying method has developed over the last 30-50 years. Spray drying increases a product's solubility, bioavailability and flow characteristics.
EUROAPI has pre-clinical, clinical and commercial spray-drying capabilities, so it can handle both small and large-scale spray drying projects. All spray dryers can handle solutions, suspensions and emulsions.
Tides CDMO Services
EUROAPI provides development and scale-up services based on Sanofi's 15 years of experience in the field of oligonucleotides and 45 years in the field of peptides. EUROAPI is responsible for a wide range of development activities, from the clinical development phase to submission and launch, including regulatory support and commercial supply. EUROAPI has over 45 years of experience in peptide development, from lab to cGMP production. EUROAPI can provide a full development pipeline for peptide synthesis, including semi-automated solvent supply and waste management.
Prostaglandins Development and Manufacturing Services
EUROAPI is a leading global supplier of prostaglandins, which are naturally produced, versatile biochemicals used to fine-tune a variety of physiological reactions. With over 15 prostaglandin APIs in its portfolio, EUROAPI provides comprehensive R&D and fully integrated cGMP manufacturing from a continuous improvement perspective.
Steroid and Hormone CDMO Services
Since its inception about a century ago, steroid and hormone manufacturing has been a core activity at EUROAPI. Today, it produces over 20 active pharmaceutical ingredients (APIs) with a steroid skeleton via complex chemical routes. It has over 100 scientists which are dedicated to small molecule synthesis and steroid development. Its site in Vertolaye, France, has a staff of over 700 experienced in corticosteroids.
Opiates & Controlled Substances CDMO Services
From poppy-seed harvesting to API manufacturing and new controlled substance development, EUROAPI provides deep synthetic chemistry expertise to meet technically and financially complex requirements, from development to commercial production.
EUROAPI, through Francopia acts as manufacturer/distributor for its entire opiate and opioid API portfolio, which is manufactured at a Sanofi-dedicated site using a continuous extraction process. It also offers controlled substance development and manufacturing, intermediates for controlled substance APIs and hemi-synthesis.
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