PART I: HPAPI Market Forecasts and Manufacturing Challenges

In this two-part blog series, Alcami Senior Director of Global Manufacturing Science and Technology, Adam Kujath, discusses the market forecasts and the main manufacturing challenges involving highly potent APIs.

The highly potent active pharmaceutical ingredient (HPAPI) market is one of the fastest growing CDMO submarkets, approaching a 9 percent compounded annual growth rate (CAGR). There is a continued industry focus on pipeline development oncology drugs, which by nature of indication is producing compounds that are increasingly potent.

Topics: Thought Leadership API HPAPI Manufacturing HPAPI

White Paper: Optimizing HPAPI Manufacturing Performance

Outsourcing highly potent active pharmaceutical ingredient (HPAPI) development and manufacturing is reaching an all-time high thanks to an increased demand of highly-targeted new drugs with greater efficacy at lower doses and the price of investment to handle internally. Several factors will dictate the performance of a contract development and manufacturing organization (CDMO) when handling HPAPIs. It is not merely a question of having the physical assets for high containment; outsourcing of a specialized and potentially challenging piece of the supply chain requires partnership and collaboration between the CDMO and sponsor. Any relationship is reliant upon transparency, team cohesion, and a level of experience that ensures a collaborative understanding with effective communication. Ultimately, success relies upon the equipment, experience, and a right-first-time ethos. Consider the factors discussed in this white paper when evaluating a potential CDMO partner.

Topics: Resource Center API HPAPI Manufacturing HPAPI Thought Leadership

ON-DEMAND WEBINAR: Approach to HPAPI Suite Design in a Multi-Use Facility

Join Alcami for a webinar to learn more about the design approach to highly potent active pharmaceutical ingredient (HPAPI) suite design in a multi-use facility.

As new drug targets naturally become more potent in the search for more effective therapeutics, there is a growing demand for capacity and capabilities in support. The development and manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPI) in a multi-use facility faces challenges of technical, procedural and a perception-based nature. Fundamentally, it all starts with the use of the right tool for the job.

Topics: Webinars HPAPI Manufacturing HPAPI CDMO API