(572b) Perfusion Cultivation Processes for Monoclonal Antibody Production in Animal Cell Culture Technology: Cell Separation

Mammalian cell cultures are the major source for a large number of very high-value recombinant therapeutic proteins, monoclonal antibodies (MAbs), viral vaccines and hormones. By 2014, it is predicted that five of the top 10 products will be antibodies (Avastin, Humira, Rituxan, Herceptin, and Remicade), along with two other recombinant protein products (Enbrel and Lantus). Furthermore about half of new therapeutic products under development are antibodies. Globally, monoclonal antibodies were expected to have sales exceeding $41 billion in the year 2010. However, efficient and reliable production technologies are required to cope with the tremendous demand for these products. Generally, large-scale commercial mammalian cell cultivations are performed in batch, fed-batch and perfusion processes. Perfusion systems involve cell retention devices, and they have the advantage of continuously removing the product and the exhausted medium, as well as the simultaneous withdrawal of the by-products, specifically toxic metabolites, which largely affect the specific growth rate. Therefore, cells cultured under perfusion culture mode can be maintained at optimal growth conditions. Accordingly, growth inhibition as well as problems with product stability can be reduced. This presentation will give a short idea about the latest developments achieved in the field of industrial production of monoclonal antibodies with a special attention to the different separation devices used in perfusion cultivations, focusing on one of these systems as a case study.