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A scale‐down mimic for mapping the process performance of centrifugation,depth and sterile filtration |
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| Authors: | Adrian Joseph Brian Kenty Michael Mollet Kenneth Hwang Steven Rose Stephen Goldrick Jean Bender Suzanne S. Farid Nigel Titchener‐Hooker |
| Affiliation: | 1. The Advanced Centre of Biochemical Engineering, Department of Biochemical Engineering, University College London, Bernard Katz Building, London, WC1E 6BT, United Kingdom;2. MedImmune LLC Gaithersburg Headquarters, One MedImmune Way, Gaithersburg, Maryland;3. +44207 679 9586+44207 916 3943 |
| Abstract: | In the production of biopharmaceuticals disk‐stack centrifugation is widely used as a harvest step for the removal of cells and cellular debris. Depth filters followed by sterile filters are often then employed to remove residual solids remaining in the centrate. Process development of centrifugation is usually conducted at pilot‐scale so as to mimic the commercial scale equipment but this method requires large quantities of cell culture and significant levels of effort for successful characterization. A scale‐down approach based upon the use of a shear device and a bench‐top centrifuge has been extended in this work towards a preparative methodology that successfully predicts the performance of the continuous centrifuge and polishing filters. The use of this methodology allows the effects of cell culture conditions and large‐scale centrifugal process parameters on subsequent filtration performance to be assessed at an early stage of process development where material availability is limited. Biotechnol. Bioeng. 2016;113: 1934–1941. © 2016 The Authors. Biotechnology and Bioengineering Published by Wiley Periodicals, Inc. |
| Keywords: | centrifugation continuous centrifugation scale‐down primary recovery mammalian cell disk‐stack centrifuge depth filter capillary shear filter capacity |