mAb quality by design

Seven leading biotech industry players have teamed up to create a fictitious monoclonal antibody (mAb) that will serve as a quality-by-design example for the industry. The newly formed consortium, which includes Conformia, a product-process life-cycle management company, aims to assist companies in interpreting and adopting quality guidelines for product development. Regulators are increasingly interested in the quality-by-design approach, which introduces the concept of quality into the manufacturing process from the start. California-based Amgen of Thousand Oaks and Genentech of S. San Francisco, Abbott, located in Abbot Park, Illinois, MedImmune of Gaithersburg, Maryland, London-based GlaxoSmithKline, Eli Lilly of Indianapolis and New York-based Pfizer form the chemistry manufacturing and controls (CMC) biotech working group involved in the project. They will use industry data to create a realistic package similar to what a company might submit for marketing authorization. The results, due Spring 2009, will be available to industry and regulators across the globe. Ken Seamon, Institute of Biotechnology, Cambridge, UK, and co-facilitator of the CMC biotech working group, noted: “Companies will end up with a more robust manufacturing process by incorporating quality by design. It may also allow more flexibility with the regulators when making changes in a process.” The initiative is part of Conformia's Cooperative Research and Development Study with the FDA.


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Aldridge, S. mAb quality by design. Nat Biotechnol 26, 958 (2008).

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