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Overview of highly potent or hi-potency APIs (HPAPIs) & more on CDMOs, CMOs offering HPAPI development & manufacturing, containment, handling, etc.

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Overview of highly potent or hi-potency APIs (HPAPIs) & more on CDMOs, CMOs offering HPAPI development & manufacturing, containment, handling, etc.

 Q1. What are Highly Potent Active Pharmaceutical Ingredients (HPAPIs)?

A highly potent active pharmaceutical ingredient (HPAPI) is generally defined as a pharmacologically active ingredient or intermediate which shows biological activity at approximately 150 µg/kg of body weight, or below in humans.

The global market for highly potent active pharmaceutical ingredients (HPAPIs) is currently on a growth fast track, largely driven by its major use in oncology for cancer treatment and more often in the form of Antibody-Drug Conjugates (ADCs). Over a quarter of drugs worldwide now contain high potency APIs (HPAPIs), as they have proven to be more effective than other APIs. 

The World Health Organization (WHO) defines an active pharmaceutical ingredient (API) as “any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings."

Typically, an API is classified as a high potency API (HPAPI) if it has an occupational exposure limit at or below 10 micrograms per cubic meter of air. A high potency API (HPAPI) or highly potent compounds are known for their ability to target diseased cells more precisely and selectively than other APIs. High-potency APIs are highly effective at much smaller dosages and hence, much more efficient in the cure of some diseases than other non potent APIs.

High potency APIs (HPAPIs) are thus extremely effective pharmacologically active pharmaceutical ingredients. They are highly specific in their action and offer significant efficiency even at low daily therapeutic doses. Furthermore, high-potency active pharmaceutical ingredients (HPAPIs) have the ability to target precise disease cells and are, hence, used in formulations for highly potent drugs.

High-potency APIs (HPAPIs) are most commonly used in hormonal drugs which are used for the treatment of breast cancer. Glaucoma is the other most important application of a highly potent active pharmaceutical ingredient (HPAPI). A highly potent active pharmaceutical ingredient (HPAPI) or highly potent compounds are also found in cardiovascular drugs, central nervous system drugs and musculoskeletal drugs.

Q2. What are the hazards in the handling of Highly Potent Active Pharmaceutical Ingredients (HPAPIs)?

The terms highly hazardous, highly active and highly potent are often used in mixed or inconsistent contexts regarding good manufacturing practices and worker safety. Chemical hazards in the pharmaceutical industry carry elevated risks, since active pharmaceutical ingredients (APIs) are specifically designed to target chemical pathways in the human body.

Handling chemicals considered hazardous therefore is more time-consuming and expensive than working with those that are not, and for a contract development and manufacturing organization (CDMO), simply treating every project as if it were highly dangerous is not appropriate. Instead, careful risk assessments are carried out before any API manufacturing project is embarked upon.

Many contract manufacturers (e.g. CDMO, CMO) are also building new facilities that are designed specifically for the development and production of potent active pharmaceutical ingredients (APIs), which require an investment of millions of dollars beyond typical GMP (good manufacturing practices) production facilities. This investment may include specialized facilities for HPAPI–antibody conjugations that incorporate both hi-potent-compound handling and biologics processing capabilities.

It is a key regulatory requirement that prospective hazards which may be encountered during the handling of complex APIs or hi-potency APIs (HPAPIs) are identified and understood to enable OEL development. This highly complex process requires extensive technical know-how. 

Together with occupational exposure banding (OEB) and other factors including short-term exposure limits (STELs), the development of an OEL enables organizations to conduct assessments for various acute, allergenic, corrosive, carcinogenic, mutagenic, toxic, reproductive, and other occupational risks.

Handling requirements for highly potent active pharmaceutical ingredients (HPAPIs) and highly potent drugs primarily includes worker protection, which requires complex air and material handling systems. Furthermore, hi-potent (HPAPI) handling systems should incorporate primary and secondary containment on five levels, starting with process isolation, to the use of the proper containment equipment, to the overall facility design, to personnel training, and finally PPE. 

Some other steps taken during designing facilities to ensure the safe handling of HPAPIs include room pressure controls, airlocks around the laboratory and manufacturing spaces, restricted entry of trained employees into the facilities, HVAC systems, etc. Necessary precautions taken before and during the manufacturing process ensure the safe handling of hi-potency APIs and highly potent drugs.

Q3. How are HAPI containment challenges addressed for a highly active pharmaceutical ingredient (HAPI)?

The increasing focus on highly potent active pharmaceutical ingredients (HPAPIs) in pharmaceutical development pipelines has led to a growing requirement for HPAPI capabilities to safely handle and contain such hazardous ingredients. 

Working with a highly active pharmaceutical ingredient (HAPI) high in potency and cytotoxicity comes with many regulations and requirements, and presents pharmaceutical companies (eg. CDMO, CMO) with challenges such as handling, containment, cost and security questions.

Highly potent active pharmaceutical ingredients (HPAPIs) have a specific OEL that must be considered by an institution to guarantee safe handling, as there is a selective process in choosing the most appropriate strategy for containment.

It’s apparent that pharmaceutical organizations offering high potent CDMO services such as development and production of potent active pharmaceutical ingredients (APIs) are recognizing the increased demand for highly active pharmaceutical ingredient (HAPI) containment capabilities, and companies are making investments and adjusting their services to meet the demand. 

In order to safely manage highly active pharmaceutical ingredient (HAPI) processes, there are several areas a contract manufacturer must consider. For example, relevant training should be provided to offer staff a comprehensive HPAPI-handling programme. Employee exposure to hi-potency APIs (HPAPIs) is typically the primary concern for manufacturers.

Additionally, the manufacturing of high-potency active pharmaceutical ingredients (HPAPIs) requires an isolated environment that is typically equipped with isolators and cleanrooms. Operated under negative pressure and with high-efficiency particulate air (HEPA) filter systems, cleanrooms prevent the emission of any highly potent active pharmaceutical ingredient (HPAPI).

Sophisticated facility design elements to address HAPI containment challenges for a highly active pharmaceutical ingredient (HAPI) include several tools to ensure safe handling of hi-potent materials. Units are available for primary and secondary containment of the entire process including solid charging containment, sampling and unloading. Furthermore, well-designed protection strategies include nuanced and detailed processes for how workers can use and clean HPAPI manufacturing ­assets.

Therefore proper systems and procedures in place for facility design, powder handling, purification, analysis, and cleaning amongst other things can provide solutions that address the risks associated with HAPI containment challenges.

Q4. Which are the leading pharmaceutical companies offering HPAPI development services?

High potency API or HPAPI development and manufacturing requires stringent safety conditions and containment. Because of the high investment in infrastructure and HPAPI capabilities, many pharma companies outsource development of highly active pharmaceutical ingredients (HAPIs) and high potency API manufacturing. 

Some leading contract manufacturers (eg. CDMO, CMO) for the production of cytotoxic and highly potent compounds offering HPAPI development and manufacturing services are noted below:

 

Minakem - High Potency API or HPAPI Development and Manufacturing Services

Minakem is a contract development and manufacturing organization (CDMO) which offers contract development and manufacturing solutions for the synthesis of APIs, intermediates and HPAPIs at all production scales including commercial-scale manufacturing.

Minakem offers state-of-the-art high containment manufacturing facilities and extremely well-trained people to handle processes from early-stage pharmaceutical development to scale-up and commercial-scale manufacturing of high potent APIs. They thereby offer the production of cytotoxic and highly potent compounds.


Fareva - Development of High Potency API (HPAPI)

Fareva helps you with your API programs, acting as a one-stop-shop for APIs, highly potent APIs (HPAPIs), OSDs and sterile products. It offers development and production of potent active pharmaceutical ingredients (APIs). It also provides contract manufacturing of APIs for innovative and generic companies. It continuously invests in new technologies for high potency, spray drying, aseptic crystallization, etc. 


AMRI - Development of Highly Active Pharmaceutical Ingredients (HAPIs) & Cytotoxics 

AMRI has 25 years of experience in the production of cytotoxic and highly potent compounds and complex APIs from grams to tens of kilograms. Certified by SafeBridge®, AMRI's facilities have the most advanced technology for high potency API manufacturing and high potent CDMO services.

It offers a complete suite of high-potency equipment and HPAPI capabilities, including process development in high potency labs, high potency suites for the production of high potency APIs (HPAPIs), expert cleaning, sanitization and decontamination processes for operator and environmental safety, etc.


Eurofins CDMO - HPAPI Development Services

Eurofins CDMO, a contract development and manufacturing organization (CDMO), offers integrated pharmaceutical development services through the entire drug product life cycle, including highly potent active pharmaceutical ingredients (HPAPIs). Their R&D and analytical facilities are equipped to handle high-potency active pharmaceutical ingredients (HPAPIs) up to SafeBridge Class IV. 

Eurofins CDMO's Development team offers high potent CDMO services and operates well-equipped laboratories to handle the most complex API development challenges including the development of highly active pharmaceutical ingredients (HAPIs). Their expertise in niche APIs enables the development and commercial-scale manufacturing of highly potent APIs (HPAPIs). R&D suites and a separated cGMP scale-up facility can handle highly potent compounds to less than 30 ng/m (Safebridge™ Class 4).