Managing risk as high-potency manufacturing scales

Managing risk as high-potency manufacturing scales 

Demand for highly potent active pharmaceutical ingredients (HPAPIs) continues to grow, driven in part by expanding oncology pipelines. While these compounds can deliver therapeutic effects at very low doses, their potency also creates significant manufacturing challenges. 

For pharmaceutical companies selecting a contract development and manufacturing organisation (CDMO), containment technology is an important consideration, but it is not the only one. Long-term success depends on whether a CDMO partner can maintain safe, reliable production as batch sizes increase, processes transfer between facilities and programme requirements change. 

Looking beyond containment 

Effective exposure control starts with an appropriate assessment of the compound and its occupational exposure limit. This information must then be translated into practical controls that protect operators throughout the process, including during sampling, cleaning and maintenance. 

Scale-up can introduce further risk. Containment measures that work during development cannot simply be assumed to remain suitable for commercial manufacture. Greater volumes may increase dust generation, change material behaviour and place additional demands on equipment. Technology transfer requires the same level of care. The receiving site must reproduce the process while maintaining containment performance, product quality and regulatory compliance. Achieving this relies on effective knowledge transfer and a clear understanding of how the product will behave within a different facility or equipment configuration. 

Manufacturers must also prepare for future needs. Automation, digital monitoring and advanced analytics are creating new opportunities to reduce operator intervention and strengthen process oversight. However, these technologies need to form part of a considered manufacturing strategy built around the requirements of the product. 

Selecting an HPAPI manufacturing partner therefore requires a broader assessment of technical capability and commercial readiness. Decisions made early in development can affect the programme well into commercial supply. 

Want to explore the risks that can shape successful HPAPI commercialisation?  

Lidia Garcia Martin, MSAT & New Productions Head at Recipharm, explains what pharmaceutical companies should consider when evaluating an HPAPI manufacturing partner. Read the full article in Contract Pharma.