The growth in targeted therapies for oncology indications is driving demand for highly potent active pharmaceutical ingredients (HPAPIs). For the most part these are small molecule cytotoxic compounds and antibody drug conjugates (ADCs) for cancer indications. Additional therapeutic areas in the HPAPI space include respiratory, hormonal, cardiovascular, and central nervous system disorders, among others.
 
With more than 20 new oncology therapies launched in the past two years it’s an area that continues to grow for pharmaceutical manufacturers and CMOs. According to MarketWatch, the HPAPI market is expected to exceed more than $28.0 billion by 2024 at a CAGR of 8.5%.
 
Due to the high level of toxicity, manufacturers must have the appropriate controls, safety equipment, and risk management processes in place to ensure a safe handling and adhere to strict regulatory requirements. Many pharma and biopharma companies opt to outsource to contract manufacturers with the necessary expertise and capabilities to handle highly potent substances.
 
PCI Pharma Services recently completed an expansion of its Rockford, IL facility to enhance its specialty drug product capabilities. The 30,000 sq.-ft. facility dedicated to specialty drug products now includes four high potent compound capable suites built to ISO8 standards. PCI also built three new secondary packaging areas to deliver increased scalability and installed three new coolers and a new freezer for -20°C to -8°C cold chain requirements.
 
Contract Pharma spoke with Michael Ellingson, Operations Director, Specialty at PCI Pharma Services about the growth of high potency APIs and the specialized manufacturing capabilities needed to handle them. –KB
 
Contract Pharma: What special requirements and capabilities are needed for high potent compounds?
 
Michael Ellingson: The demand for Highly Potent Active Pharmaceutical Ingredients (HPAPI) continues to grow with oncology drugs accounting for nearly 40% of the global clinical pipeline. As we are seeing an increased demand for HPAPI handling, we are focusing on improving our capacity and capabilities to meet customer requirements. To meet these goals, we recently finished the expansion of our existing Rockford, IL facility, which included high potent compound capable suites that are built to IS08 standards. These suites act as a containment measure achieved through negative and positive pressure, and heightened air filtering.  
 
Our teams also work to meet strict regulatory requirements, such as cross-contamination controls, and reliable reproducibility through geometric scale-up. Our facility in Tredegar, South Wales also meets these requirements and we’ve started an expansion at this facility to further support business growth and we expect this new space to be operational in the first half of 2022. 
 
CP: In what therapeutic areas do you see the most growth?
 
ME: As we continue to see an increase in innovation and research across the oncology ecosystem, there begins to be a stronger need for high potent compounds to support these advancements. Active compounds in oncology research and development has quadrupled since 1996 and doubled since 2008. PCI Pharma Services has supported this growth and has simultaneously seen demands for our services and partnerships increase. We work with our clients from early stage development to long term commercial supply. Staggering growth in oncology R&D presents an opportunity for PCI to increase our manufacturing capabilities and packaging capabilities. We aim to provide services and a supply chain from start to finish – from drug development to commercialization – and as oncology drugs are continuing to be developed, we work with our clients to provide solutions to challenges to ultimately deliver life-changing treatments to patients.
 
CP: From what pharma/biopharma sector do you see the most demand?
 
ME: We have seen consistent growth in oncology products, along with high potent compounds and products to treat specific food allergens. The industry has seen a significant shift in the ability of small and mid-size pharmaceutical companies to bring projects to the finish line of commercialization.
 
Although we continue to see growth in big pharmaceutical companies, the growth rate in small and mid-size companies is outpacing that of their larger peers in the space. As such, PCI has added to our service offerings with clinical support, packaging options and program management skills in the end-to-end commercialization process as to provide start to finish support for customers. For obvious reasons, this support tends to be most critical for smaller, often less experienced, startup customers.

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Michael is the Director of Specialty Operations where he focuses on driving process improvements and oversees operational excellence. Prior to his current role, Michael held key positions across PCI’s project management and operations teams. In addition to his responsibilities at PCI, Mike is the site SME for a recent S&OP implementation project where he manages all scheduling, forecasting, capacity analyses and labor management for the Rockford Commercial sites.