Untitled Document
At the Spring 2011 ExcipientFest/IPEC conference, PharmTech moderated two speakers roundtables’ regarding developing issues in excipient functionality and continuous manufacturing. Audio files are provided below.
Continuous Manufacturing; Challenges of Going Back to the Future
Continuous manufacturing offers the advantages of a flexible batch size, potential cost savings, reduced or no scale-up activities between R&D and operations, and a smaller equipment carbon footprint. But there are still challenges to resolve, and questions remain as industry moves further into this new manufacturing paradigm. Exactly how to plan for scale up and a lack of state-of-the-art equipment for all processes pose some problems. And regulatory expectations regarding increased levels of process and product understanding needed to justify a continuous process need further clarification. This roundtable, sponsored by ISP, works through some of these issues. Listen to the audio.
On the panel:
- Francis Godwin, Compliance Officer in the Division of Manufacturing and Product Quality, FDA
- Dr. Stu Porter, Senior Director of Global Pharmaceutical Applications R&D, ISP
- Mark Neidlinger, Process Engineering Manager at the Pharma Division, GEA Process Engineering
- Brett Alexander, Senior Scientist in Global Technical Services, AstraZeneca, US
- Chris Moreton, head of FinnBrit Consulting and member of USP and IPEC expert committees
Moderated by Angie Drakulich, sr. managing editor, Pharmaceutical Technology
Excipient Functionality and Developing Issues
As FDA and other regulatory agencies stress the importance of process and product understanding, the functionality and variability of excipients become extremely important. Excipients vary from APIs by their very nature and have unique properties and characteristics that must be identified, understood, and monitored in the drug manufacturing industry. This roundtable, sponsored by BASF, looks at these issues in detail. Listen to the audio.
On the panel:
- Dr. Cindy Buhse, Director of the Division of Pharmaceutical Analysis, FDA’s Office of Pharmaceutical Science, CDER, FDA
- Catherine M. Sheehan, Director of Excipients at the United States Pharmacopeia, in the Department of Standards Development
- Dr. Lawrence Block, Chair of the USP Excipient Monographs Expert Committee, and a Professor of Pharmaceutics at Duquesne University
- Nigel Langley, head of Technical Sales for Pharma Ingredients & Services at BASF
- Chris Moreton, head of FinnBrit Consulting and member of USP and IPEC expert committees
- Dr. Stephen W. Hoag, a Professor at the University of Maryland’s Baltimore School of Pharmacy and a member of the USP Counsel of Experts. swhoag@gmail.com
Moderated by Angie Drakulich, sr. managing editor, Pharmaceutical Technology
