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.

What's on Your QbD Calendar?

Some great events taking shape this fall for Quality by Design, in case you hadn't heard:

Practical Solutions to PAT and QbD Workshop, Oct. 20-21, London

Process Chemmistry in the Pharma Industry (with Special Emphasis on Continuous Manufacturing), Nov. 2-4, Durham, N.C.--James Evans of the Novartis-MIT Center has put together a great panel on continuous mfg.

AIChE QbD Topical Conference, Nov. 8-13, Nashville, TN--the QbD thread runs throughout the event.

Eastern Analytical Symposium, Nov. 16-19, Somerset, NJ

AAPS and ISPE meetings in early November (both in Southern California) will also have plenty of QbD on tap.

--Paul Thomas

Can PCMO and PQLI Work in Harmony for Paradigm Change?

PDA has stepped up its efforts to get its training and technical reports more in tune with ICH and a more risk- and science-based industry. These efforts have been underway, says PDA's Rich Levy, but the Paradigm Change in Manufacturing Operations initiative puts them into focus.

PDA has drafted a dossier around four key themes: Life Cycle Approach, Quality Systems, Process Management, and Quality Risk Management, and will use this dossier as the umbrella under which ongoing efforts will be undertaken.

In this article from my recent discussion with Levy, he goes out of his way to emphasize that PCMO is intended to complement, not counter, PQLI efforts already underway at ISPE.

--Paul Thomas

Pharmaceutical Allies: QbD and Six Sigma

A rather lengthy but good PowerPoint presentation from an ISPE breakfast seminar on the link between QbD and Design for Six Sigma, courtesy of consultant Murray Adams.

--Paul Thomas