A-Mab Case Study: Read It and Weep?

Now that the A-Mab Case Study has hit the streets (click here), the next question is just how much of an impact it will have upon the arc of QbD. If you're fairly new to Quality by Design and how it might be implemented at your facility or company (whether you're in biologics manufacturing or not), A-Mab will: a) give you loads of exciting concepts and data to ponder, hopefully opening doors to innovative QbD work; or b) intimidate the heck out of you and cause you to break down in tears.

A-Mab is 278 pages of intense concepts, data, and charts related to how QbD can be applied throughout the development of a typical biologics molecule. Where do you start? Where do you find what is truly relevant for your operations and applications?

I posed these questions, separately, to two people who were integral in shepherding the A-Mab project through--Sam Venugopal of PRTM Management Consultants, and John Berridge, a consultant and project manager for ISPE's PQLI initiative. (Click on their names to read summaries of our talks.) Both men admit that manufacturers will have to work hard to digest the document and assess how it applies to them. But both also see the document for what it is--a milestone for Quality by Design and unlike anything else that's been done previously.

Workshops focused on A-Mab will be held throughout 2010 by ISPE and CASSS.