GMP News: Interesting Case Study on Quality by Design for Vaccines

Interesting Case Study on Quality by Design for Vaccines

A case study issued in 2009 already concentrated on the application of Quality by Design for monoclonal antibodies. Now suggestions have been collected for a case study for vaccines. Five companies - GSK, Medimmune, Merck, Pfizer und Sanofi Pasteur - worked together in this Vaccine Working Group (VWG). The VWG's goal was to find out whether and how QbD can be applied in the development and manufacture of vaccines. The document from April 2012 comprises 383 pages! A particularity with regard to vaccines is that most of these products are given prophylactically to healthy individuals. A possible benefit mentioned is that a QbD approach also questions traditional proceedings in the development of vaccines. In any case, the application of QbD results in a better understanding of products and processes. It is also easier to predict the impact on future process changes. Two Biotech Case Studies on the implementation of QbD are also essential parts of theQbD/PAT Conference of the University of Heidelberg on 26/27 September. These case studies will be introduced by Dr Ron Taticek, Genentech, USA and Dr Jörg Gampfer, Baxter, Austria. Find further information in the PDA Case Study "A-VAX: Applying Quality by Design to Vaccines" (Size: 8.6 MB!). Author: Dr. Günter Brendelberger CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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