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.
Rights and permissions
About this article
Cite this article
Aldridge, S. mAb quality by design. Nat Biotechnol 26, 958 (2008). https://doi.org/10.1038/nbt0908-958b
Issue Date:
DOI: https://doi.org/10.1038/nbt0908-958b