Handling unexpected process changes | Changing harvest filters

Genmab had already established a robust clearance process when the COVID-19 pandemic disrupted the delivery of a necessary harvest filter. They had to switch to a different filter setup before going commercial - resulting in an acute need to document its efficiency.
Using mass spectrometry (LC-MS/MS)-based analysis, Genmab quickly got data to determine the effect of the original harvest filter on the Host Cell Protein (HCP) profile of their product, evaluate alternative harvest filter setups, and document the clearance of HCPs with the new setup.
They included the LC-MS data in their BLA to document the efficiency of this purification step.
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Watch the webinar with Margarita Sabater, Senior CMC Specialist at Genmab, to learn more about process development and investigation of problematic HCPs using LC-MS - and the feedback they received from the regulatory authorities in the US, EU, Canada, and Japan: alphalyse.com/genmab