In the past decade biopharmaceutical manufacturing demonstrated major improvements in mAb production, exhibiting product titers of 10 g/L in standard fed-batch mammalian cell cultures. The increased product yields allow for smaller scale production vessels and with 2000 L single use bioreactors already commercially available, single use manufacturing becomes more and more an option.<br/><br/>Although single use technology has matured considerably in the last few years, some unit operations such as cell harvesting still need more attention in order to become more economical and robust. A relatively new and promising technique Dynamic-Body-Feed Filtration (DBF Filtration), uses diatomaceous earth (DE) as a filter aid, was tested in combination with a flocculent called chitosan (CTS). CTS is a relatively inexpensive, non-hazardous and easy to use flocculent. The particle size of the CTS treated cell broth was also measured to investigate the flocculation characteristics. Finally, the impurity content and product titer of CTS treated filtrates were compared to a standard DBF filtration at pH 5.0 without CTS.

Enhancement of dynamic body feed clarification performance using chitosan treatment

251st National Meeting (2016)

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