CONCLUSION
The single-use FBC was evaluated for cell-harvesting applications. After determining the maximum capacity of each single-use
chamber and the initial and processing flow rates, five total cell-harvesting runs were completed. Cell density, NTU, LDH
levels, and residual DNA content from the centrate were collected for evaluating the system. Low cell density and turbidity
in the centrate indicated that clarification efficiency was high, and little to no change in the LDH level tle cell lysis
during processing. Compared to disc-stack centrifuges and other current standard technologies, it can be concluded that the
FBC system is an attractive single-use alternative to current options for cell harvesting.
ACKNOWLEDGMENTS
The authors would like to acknowledge the following individuals for their contributions: Sunil Mehta and Tod Herman for providing
their expertise on the FBC; Divya Harjani and Nikhil Patel for maintaining CHO cell cultures and assistance in carrying out
some of the FBC runs; Meredith Rice for her assistance with the turbidimeter; and the Janssen R&D Process Analytical Support
group for analyzing the residual DNA and antibody titer samples.
Hsu-Feng Ko is a research scientist and Ravi Bhatia is associate director, both at Janssen Research & Development, Spring House, PA. hko@its.jnj.com
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