(571t) Small-Scale Method for Determination of Cell Lysis in Harvested Cell Culture Fluid

Platform cell culture processes can show variable characteristics in the harvested cell culture fluid with respect to cell lysis, as determined by LDH release. An increase in cell lysis during harvest has the potential to introduce challenges for downstream processing and the resulting product quality. As a risk mitigation effort, a small-scale laboratory method was developed to help predict a cell line's susceptibility to lysis early on in its development. This method could also be used to screen harvest conditions and reagent additions that may reduce cell lysis. Using this small-scale method, we have generated data to show the effects of varying culture conditions on cell lysis as well as comparative data among cell lines that may be used to predict future efforts related to lysis effects on product quality.