Are you ready for FDA
questions about impurities?
WHAT to measure - and HOW
When you submit an IND for a Cell or Gene Therapy product, guidelines state that you must measure process-related impurities in the drug substance and monitor process performance parameters for process consistency.
Often there is no impurity ELISA available – or the host cell protein (HCP) coverage of the ELISA is low. So how do you find a good impurity assay?
In 30 minutes, you get an overview of the documentation guidelines for process-related impurities in cell and gene therapies. You are also introduced to a mass spectrometry method to monitor multiple proteins with one assay.