Highly potent APIs - can your CMO handle them?

The importance of ensuring a facility has the right capabilities when selecting a CMO to handle high potency ingredients.

What should pharma companies consider when selecting a CMO for high potency production?

"Safety is a priority. The development and manufacturing of high potency products requires significant investment in high containment facilities, protective equipment and personnel training.

Introducing a new highly potent API into a manufacturing facility poses a risk that should always be handled with a thorough analysis of safety measures and cleaning levels. These issues should all be addressed and demonstrated by the CMO as part of the selection process.

At Idifarma, for instance, we can work with highly potent compounds up to level 4 OEB/OEL. We always conduct our own risk analysis for every new product - taking into account our facilities, equipment and personal protective equipment - to ensure we can handle it safely and without compromising quality."

High potency production obviously involves strict regulation too. What regulations should manufacturers follow within high potency facilities?

"The essential regulations are Good Manufacturing Practice (GMP), health and safety regulations for workers and environmental laws.

Recent updates to GMP determine a new approach to risk analysis based on toxicological assessments for shared or multi-product facilities, which covers most manufacturing sites. There are also changes related to prevention of cross contamination and supply chain traceability.

In addition, the European Medicines Agency (EMA) guidelines on setting health-based exposure limits should also be adhered to."

So, all manufacturers offering high potency facilities should in effect offer the same basic technical capabilities, quality and safety assurances. What other qualities should pharmaceutical companies be looking for in a CMO partner?

"Yes, there are minimum requirements, such as quality, technology and safety, which can be objectively assessed through HSE and quality audits. But then there are other aspects that should be checked when making a decision and these are usually harder to ascertain: client orientation and alignment, absence of conflicts of interest, reliability, flexibility and responsiveness. A track record of success and evidence of a long-term, company-wide commitment to HPAPI production are also equally important.

Price is also understandably a factor ,but prioritising this is often proven to be a risky strategy and not recommended."

What are the industry trends driving the need for more high potency capabilities?

"There is clearly growing market demand for high potency capabilities due to a number of factors. For example, there are an increasing number of ‘families’ of highly potent APIs for oncology treatments, such as the ‘nibs’ family of products (such as Sunitinib, Erlotinib and Sorafenib), being developed and marketed, which require specialised development and manufacturing facilities.

Increasing regulatory, safety and environmental requirements are also driving the need for specialist providers of high potency capabilities in the pharmaceutical industry."

In your opinion, what does the future hold for high potency facilities?

"Currently, approximately 25% of drugs in development worldwide are classified as highly potent. This number continues to rise, driven in particular by growth in the oncology market and cancer-related drugs, which account for approximately 60% of all highly potent APIs.

Because of this, I expect the demand for high potency CDMOs will grow steadily over the next 5-10 years, since the relevant investment needed for high potency facilities are capital intensive and are usually a deterrent for many clients to invest themselves. Instead, the outsourcing sector offers them readily available economical and efficient solutions.

Manuel Leal, is the Business Development Director at Idifarma. He is responsible for generating new business for the Spanish contract development and manufacturing organisation (CDMO) and exploring international markets as part of the company’s ongoing growth strategy."