Looking for a Few Good Authors: QbD "From Theory to Praxis"

PAREXEL's Siegfried Schmitt is looking for chapter authors for a book titled, "Quality by Design: From Theory to Praxis," to be published by PDA. You may contact Siegfried via his LinkedIn posting, or directly at siegfried.schmitt@parexel.com.

The following are some parameters that Schmitt has shared with us:
• Authors may write part or a whole chapter (or several)
• Authors should outline either in bullet points or in prose what they want to cover (structure and contents of their contribution) by mid-February 2010
• Schmitt will provide feedback and suggestions
• Drafts should be completed by June 2010
• Revisions are expected by the end of August 2010

Authors may include text from existing publications, Schmitt says, provided they have been adapted for this publication. References should be listed in a separate table.

Where Lies QbD's Competitive Advantage?

I've had the good fortune of speaking this week with Volker Eck, senior director of science and technology at PDA, and a day later with Graham Cook, Wyeth's senior director for process knowledge/Quality by Design. Both men were integral participants in late September's workshop in Frankfurt,  hosted by PDA, to unveil and discuss EFPIA's mock examples of Quality by Design implementation.

By all accounts, the mock examples were well received and the meeting was an important step toward helping manufacturers not just interpret ICH guidances but grasp how QbD might look for their products and processes. The mock examples are now being finalized, following input from the Frankfurt meeting and one earlier with EMEA in London, and are expected to be made public later this year.

You can read my summary of Eck's take on the meeting here, and I hope to have a podcast of my interview with Cook available within a week or two. Eck was insightful in that he said that many manufacturers at the Frankfurt meeting were still clearly struggling to "translate" the ICH documents, and the mock examples, to their own operations. With QbD, manufacturers can only truly learn by doing and thus will have to dive in

EFPIA Ready to Roll Out Its QbD "Concept Cars"

In anticipation of its QbD workshop in Frankfurt on Sept. 22-23, PDA has released a special report on the impending EFPIA "Mock QbD" examples that will be summarized and discussed at the meeting. In the report, Wyeth's Graham Cook, Merck's Robert Schnepf, and Abbott's Brian Withers discuss the thinking behind, and importance of, the EFPIA examples, which will focus on terminally sterilized injectables, lyophilized injectables, small molecule API's, and monoclonal antibody API's.

Cook explains: You could compare the Mock documents to a concept car that you might see at a motor show. It has the look and feel of the future model, but not necessarily all technological parts are fully developed or built in to enable it to operate at full performance. Creating scientifically credible stories for the development of the hypothetical drug substances described in the Mock documents is not easy and so, in many cases, the team members would base the sections they were writing on real examples from within their companies and change them to fit the story we were trying to tell. When the groups had to decide what process steps or unit operations should be discussed, the principal selection criteria was to show examples that could be used to illustrate ideas and the use of tools, and perhaps provide a model for others.

Thanks to Parexel's Siegfried Schmitt for calling our attention to this on the Quality-by-Design LinkedIn group.

--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

QbD for Biopharma: New Course at PDA FDA Joint Conference

This year's PDA FDA Joint Regulatory Conference in D.C. in mid-September has an excellent program top to bottom. (Here's the agenda.) It will also feature a new course by Anurag Rathore (see yesterday's post on his new book) on QbD for Biopharma.

Rathore has just posted the tentative outline for the course on our LinkedIn group. If you're not a LinkedIn member, here is his overview--comments are welcome as the program is finalized.

Critical Quality Attributes (Patrick Swann): Potential CQAs for Mabs; Biological Activity Matrix; Product-related variants; Characterization of variants and setting limits (ICH Q5E); Clinical pharmacology studies; Specifications (ICH Q6B); Biological characterization

Design Space (Anurag Rathore): Clinical design space; Product design space; Process design space; Case Study I – Establishing process design space for a Pichia fermentation product; Scale down modeling; Failure Mode and Effects Analysis (FMEA); Design of Experiments (DOE); Parameter-parameter interactions; Worst case studies

Group work I (All): Group discussion to identify and list gaps attendees see with respect to molecules under commercialization at present and also legacy products.

Risk Assessment and Management (Patrick Swann): Review of historical approaches; ICH Q9 guidance; Quality risk management process; FMEA

Regulatory Aspects (Patrick Swann): OBP QbD pilot program; Observations based on review of proposals for categorizing quality attributes

Establishing Control Strategy and Lifecycle Management of Design Space (Anurag Rathore): Creating control strategy; Process validation; Filing; Process monitoring; Raw material management; Process analytical technology (PAT); Case Stud II – Multivariate analysis for a mammalian cell culture step

Group work II (All): Group discussion of gaps identified earlier

PDA Releases Dossier for Paradigm Change Initiative

PDA has instituted a new "Paradigm Change in Manufacturing Operations" (PCMO) initiative, based largely on encouraging ICH guidance within its organization and the industry. Here is the PCMO dossier, and we'll be following up with PDA in the near future.

--Paul Thomas