Highly potent APIs - can your CMO handle them?22 Sep 2017
The importance of ensuring a facility has the right capabilities when selecting a CMO to handle high potency ingredients.
The growing market demand for high potency capabilities invariably means more companies are having to choose a reliable CMO partner. Easier said than done! Help, however, is at hand, as Manuel Leal, Business Development Director at Idifarma, shares his insight to help companies navigate their way through this potentially tricky course.
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."
Catalent extends global commercial spray drying capabilities in Europe
9 Jul 2019
Company's customers to have immediate access to Niro PSD2 and PSD4 spray driers, which are supported by dedicated clean area facilities for both solvent and aqueous processing of potent or non-potent drug formulations.Read more
Inaugural Bio Integrates conference highlights industry's inefficiency in developing products
18 Jun 2019
Industry leaders give voice to issues and trends shaping the biotech sector, including the importance of collaboration.Read more
Lessons learned from early EU FMD adopters
13 May 2019
Data exchange, investment costs, resources and hardware identified as some of the biggest challenges.Read more
Brexit's trick or treat on patient safety
29 Apr 2019
Despite a delayed Brexit, unpredictability adds further complications to the EU FMD regulation.Read more
Surge of Indian biosimilars market forecast in 2019
22 Apr 2019
India predicted to be one of the world’s ‘fastest growing bio’ hubs in 2019, fuelled by new biosimilars production.Read more
RAPS on delayed Brexit
26 Mar 2019
The post-Brexit regulatory environment continues to weigh heavily on the minds of regulatory professionals.Read more
Sizeable growth potential for global drug delivery and packaging in 2019
19 Mar 2019
Patient-centricity, eco-friendly and smart packaging trends marked as the biggest growth drivers and innovations in 2019.Read more
'Tamper-evident' benefits are evident
28 Feb 2019
2019 will mark Uniplast's debut at this year's edition of CPhI Worlwide in Frankfurt, where it will showcase its expertise in plastic packaging.Read more
All Recipharm facilities ready for EU serialisation, regardless of Brexit
15 Feb 2019
The CDMO invested EUR 35 million into its operations and launched a 3-year programme to provide a compliant serialisation solution for its customers.Read more
Brexit - the EU FMD's painful problem
7 Feb 2019
Teething problems are no stranger to the implementation of new regulations, but with the EU FMD, Brexit came like a set of wisdom teeth – late, painful and problematic.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation