Triton X-100 is a non-ionic detergent and can provide robust inactivation of enveloped viruses. Adding Triton X-100 in harvested cell culture fluid (HCCF) has been proven as an effective step for viral inactivation in the purification process. Protein A titer assay is widely used to determine product titer of HCCF in the monoclonal antibody (MAb) cell culture production. The evaluation of the titer assay performance with Triton X-100 addition in HCCF was concerted in different testing laboratories of Genentech. In this presentation, we will show the results of chromatographic profiles and titer values with multiple products, and the investigation of several factors possibly attributed to titer assay performance variations.

Evaluation of protein A titer assay performance with harvested cell culture fluid containing Triton X-100

241st National Meeting (2011)

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