This session deals with the adoption of ‘Quality by Design’ (QbD) principles in the (bio) pharmaceutical industry. QbD is based upon a rational approach of the process development of new products and an awareness of the risks for the patients receiving the new product. QbD means that the process for the new products is controlled in such a way that the process will result in a product with the defined characteristics. Last year the American CMC Biotech Working Group published the ‘A-Mab: a Case Study in Bioprocess Development’. This document describes the essentials of QbD for the development of monoclonal antibodies to be applied as therapeutics in humans. The practical consequences of this document will be explained during this session.

Speakers:

·         Jan Willem Dorpema, Vice-President, BioFarmind

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·         Patrick van Berkel, Senior Director CMC R&D, Genmab

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·         Hans ter Maat, Senior Process Engineer, DSM

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