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John Murphy
John Murphy

Public Documents 1
Evaluation of the StreamLink® CC 15 as a Clarification Replacement to Manual Centrifu...
John Murphy
Jan Kemper

John Murphy

and 7 more

August 24, 2024
The production of secreted therapeutic proteins, such as monoclonal antibodies, often requires cultivating CHO cell cultures in bioreactors ranging from 10 mL to 20,000 L in volume. The cells proliferate and secrete the therapeutic protein over multiple days and the bioreactor is then emptied to collect the culture broth. The first step in the purification process removes any insoluble cells and cellular debris to produce a clarified conditioned medium (CM). Manufacturing scales frequently use continuous centrifugation followed by depth filtration for clarification of CM, but this method is challenging to reproduce with small volumes generated during bench scale experiments. The typical bench scale clarification method consists of a time-consuming centrifugation step to pellet the cells and cellular debris followed by the careful removal of the supernatant which is filtered through a 0.2-μm filter. This study evaluates a robotic clarification process using the commercially available Sartorius StreamLink® CC15. Our results demonstrate that the StreamLink reduces scientist manual time and effectively clarifies material without impacting quality attributes, when compared to manual clarification. Furthermore, we provide guidance on optimizing sample and system parameters to maximize product recovery.

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