The HPAPI Summit is a recurring event designed to gather manufacturing specialists, chemists, researchers and other stakeholders to discuss current and emerging trends around high-potency active pharmaceutical ingredients (HPAPIs). Organizations represented in the presenter list include AstraZeneca, Abbvie, Bristol-Myers Squibb, Merck, Boehringer Ingelheim, Lonza, Genentech, Allergan and more.
Scheduled to take place November 18-20 in Boston (rescheduled from June 1-3), the event will consist of workshops, interactive sessions, networking opportunities and other programming. According to event organizers, the HPAPI Summit is intended to provide attendees with a wide range of information in several knowledge areas, including:
- Learning and evaluating the latest technological innovations
- Process design and development, ranging from R&D to commercial manufacturing
- Regulatory foundations and updates to help ensure operations are compliant
- Creating a fit-for-purpose environmental, heath and safety (EHS) program
- Defining contract development and manufacturing organization (CDMO) partnerships, technology transfer and risk mitigation.
The HPAPI Summit’s first day will consist of a series of workshops, each tackling a different area dedicated to gaining a better understanding of current concerns around HPAPIs. The planned sessions are:
- Verification of Containment Performance: attendees will learn about and discuss the importance of properly functioning containment equipment, designing a study to evaluate performance of such devices, the ins and outs of factory and site-acceptance testing and more.
- Isolator Design for Operator Safety and Filing for Proper US: participants will develop a generic containment strategy that can be applied to any isolator, then figure out how to adapt to meet specific situational needs.
- Managing Variability in OEL and How to Calculate OEL: this session will address how to explain, demonstrate, practice and evaluate processes used to derive occupational exposure limits (OELs) and identify special hazards.
The agenda for the next two days consists of informational sessions on a broad range of relevant topics, including manufacturing and technology transfer, best EHS practices, regulatory issues, data, sustainability, facility design and other topics. Interspersed among the sessions are networking sessions and poster sessions.
For more information about the event, visit HPAPI-Summit.com.
