This is one of the questions that was posed to several HPAPI leaders by Pharmaceutical Outsourcing, at their High Potency API Roundtable. We found this particularly interesting to hear their thoughts. Read on for an extract of their answers, of you can view the full article here >
As seen on Pharmaceutical Outsourcing:
‘Response from Max Lazar, President, FDA Regulatory Compliance Consulting:
From my perspective, High Potency APIs have been exhibiting a continued growth in its market. My professional experience and focus has long been on Active Pharmaceutical Ingredients and the need for their Production, Distribution, and Quality to meet the intention of the internationally accepted API GMP. This growth, in the market and its producers, is the single largest and important trend that deserves attention by all players in this field.
More compounds of concern continue to be developed in both the synthetic chemical and biopharmaceutical arenas. High potency APIs offer the benefit of requiring lower amounts of compounds to be produced. However, these new HPAPI are not only highly potent, but are also potentially harmful when present, even at very low levels, in another product. This very risk is historically associated with the unexpected presence of penicillin type antibiotics or other sensitizing compounds being present in other products as a cross contaminant.
From my perspective, as one focused on regulatory compliance issues, all high potency APIs must be produced under conditions that protect any API substances from contamination and the inadvertent carryover of a different product being previously or simultaneously manufactured. While todays modern HPAPI facilities are meeting today’s requirements, I see a growing need to improve these technologies. To accomplish this task, I see a continued need to focus on the development of production and handling methods that will be either single-use systems and/or new technologies which can continue to improve upon today’s product protection of the API from cross contamination from other HPAPI produced at the facility or site. Such protection systems must focus on cleaning and removal systems utilized for such product protection purposes.
Multiproduct facilities pose the greatest risk to exposing one API to another high potency API. This growth in the HPAPI, the producers and the plants around the globe are creating many new players from even new countries. As the mix of manufacturing sites and countries keep changing, regulatory risks will continue to grow because it will become more expensive and difficult for regulators and drug product manufacturers to keep a close watch on API producers.
Response from Jimmy Burke (Director of Manufacturing) and Kevin Brady (Director of Operational Excellence and Supply Chain), Alkermes:
As a secondary processor of High Potency APIs (HPAPIs) i.e., dosage form scale up and manufacturing, the single largest trend we see at Alkermes Contract Pharma Services is the need for high containment technologies to safely handle and manipulate these materials. The number of HPAPI-products requiring lower Operator Exposure Levels (OELs) is increasing, resulting in containment challenges for equipment manufacturers who are trying to design and implement solutions requiring very high levels of containment.
Response from Emma Mickley, Vice President of Corporate Business Development, Aesica Pharmaceuticals:
The only way is up for the multi-billion dollar high potency API (HPAPI) market. Continued growth is certain as translational science continues to evolve and identify more molecular targets specifically expressed or associated with certain pathophysiologies, diseases and conditions.
Currently, the majority of HPAPIs are anti-cancer products (cytotoxics and cytostatics). However, other HPAPIs include therapeutics such as hormones, narcotics and retinoids. Whilst we initially think of HPAPIs as chemically derived products, biological therapeutics – such as monoclonal antibodies – are also HPAPIs by their very nature.
Surveying worldwide and company-wide development pipelines, the area of oncology will clearly continue to dominate the types of HPAPI molecules coming through clinical trials to market launch. Not only is oncology the largest therapeutic area by far in terms of revenue generation for pharma, it is also one of the fastest growing, estimated at over 7% growth year on year for the next six years.
Our own experience as a Contract Manufacturing Organization (CMO) reflects this trend, and over the last few years we’ve seen a rising demand for the development, manufacture and handling of HPAPIs New Chemical Entities (NCE). This has primarily been within the area of anti-cancers but also in cancer-related treatments such as pain relief medication.
Interestingly, a significant proportion of these projects are being outsourced from big pharma. This represents a move away from previous API outsourcing habits, since historically big pharma would keep its cards close to its chest when it came to outsourcing NCE, on-patent products. However, the resource demands and level of specialization needed to manufacture relatively small volumes of HPAPI means that often it isn’t economically viable to keep this in-house. To that end, we’re seeing definite growth in demand for manufacturing of HPAPI destined for use in on-patent products. EvaluatePharma, Embracing the Patent Cliff World Preview 2018, June 2012.’
Interested in the HPAPI market? Plans are already underway for the new and exciting HPAPI World Congress – taking place this February, 26-27th, in Munich. Check it out now!