This webcast features: Jessica Waller, PhD, Principal Scientist Biologics Development, Bristol Myers Squibb.
Bispecific antibody configurations with multi-targeting capabilities are evolving as new generation biologic therapeutics with potential for enhanced efficacy and reduced toxicity. Significant challenges arise with downstream purification of these molecules due to a unique panel of product-related variants or mispaired species that must be monitored and cleared in product pools.
Viral clearance capability is another critical component when developing a downstream process, as mammalian CHO-derived products have an inherent risk for viral contamination. Considering these challenges, a three-step chromatography approach, all operated in bind-and-elute mode, is employed to achieve removal of process and product related impurities prior to the dedicated viral clearance nanofiltration step.
However, the feed stream leading into the viral filtration step can be characterized by high concentration and conductivity from the last chromatography polishing step as well as contain residual impurities that can impact nanofiltration performance.
Thus, there is a need for a robust viral filter for these more complex molecular configurations. We assessed performance of PlanovaTM, including the new generation PlanovaTM S20N, and flat-sheet nanofilters for a multi-specific antibody. High capacity with minimal decay across PlanovaTM 20N, BioEX, and S20N was achieved. Therefore, hollow-fiber nanofilter technology exhibits superior performance and viral removal capability for these more complex therapeutic targets.
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