Quality by Design for Biotechnology Products—Part 1 - A PhRMA Working Group's advice on applying QbD to biotech. - BioPharm International


Quality by Design for Biotechnology Products—Part 1


Parts 2 and 3 of this article will appear in the December and January issues. Part 2 will cover the use of DOE to define the design space, unique considerations for process development for biopharmaceuticals, the establishment of a control strategy, and the placement of QbD information in a regultory application. Part 3 will discuss continuous verification and post-approval changes, including topics such as verification at large scale, refinement of the design space, process changes and comparability, comparability protocols and expanded change protocols, marketed products, and a CMC post-approval management plan. It will also include the overall conclusions.

Taruna Arora is a principal scientist, protein science, Roger Greene is the director of regulatory affairs, Jennifer Mercer is the director of regulatory affairs, CMC, and Paul Tsang is the executive director of quality, all at Amgen Inc.; Meg Casais is the director of global regulatory affairs, CMC, and Stuart Feldman is the director/CMC, global regulatory affairs, both at Schering Plough; Jutta Look is the senior manager, CMC regulatory affairs at Novartis Pharma AG; Tony Lubiniecki is the vice president of biopharmaceutical development & marketed product support at Centocor R&D, Inc.; Joseph Mezzatesta is the assistant director of regulatory CMC, corporate regulatory affairs, at Sanofi-Aventis; Stefanie Pluschkell is an associate research fellow in global CMC, biologics and devices, at Pfizer Inc.; Mark Rosolowsky is the executive director of global regulatory sciences–CMC at Bristol Myers Squibb; Anurag Rathore is a biotech CMC consultant and faculty member at the Indian Institute of Technology, Delhi, India; Mark Schenerman is the vice president of analytical biochemistry at MedImmune; Tim Schofield is the director of US regulatory affairs at GlaxoSmithKline; Samantha Sheridan is the director of regulatory affairs at Shire Pharmaceuticals; Paul Smock is a director and quality product leader in Wyeth Biotech, Wyeth Pharmaceuticals; Sally Anliker is the director of regulatory affairs CMC, Lois Atkins is a principal consultant, CMC regulatory affairs, Bernerd McGarvey is an engineering advisor in the process engineering center, Bruce Meiklejohn is a principal fellow, regulatory COE-biotech, Jim Precup is a research scientist in manufacturing, science and technology, and John Towns is the senior director of global CMC regulatory affairs, all at Eli Lilly and Company. Towns is also the chair of the working group, 317.276.4079,


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