Journal
JOURNAL OF BIOTECHNOLOGY
Volume 213, Issue -, Pages 20-27Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jbiotec.2015.02.021
Keywords
Continuous bioprocessing; Semi continuous bioprocessing; Blood clotting factors; BeneFIX; ReFacto; Re Facto AF; Xyntha; Factor IX, factor VIII; Perfusion Re feed; Post translational modifications; Gamma-carboxylation
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Recombinant clotting factors are important biotherapeutics that Pfizer has produced and marketed for over fifteen years. Owing to the complexity of the structure and function of these blood factors, it can be challenging to achieve the required product quality and manufacturing productivity. The article highlights the semi-continuous and continuous cell culture processes employed by Pfizer for the production of BeneFIX and ReFacto AF. The benefits of such processes, the challenges of maintaining an aseptic production culture for extended periods, and batch definition are discussed in this article. (C) 2015 Elsevier B.V. All rights reserved.
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