Cell & gene therapies – WHAT to measure and HOW

September 29 2020

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.

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