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:
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: