At what stage(s) of the production cycle should you test for residual enzymes?
This question is part of the following Ask The Expert session:
Verifying Removal of Residual Production Enzymes from Your Final Product
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Answer
This is very much up to the discretion of the individual company and your risk mitigation strategy. Testing can be done as an in-process control to monitor efficiency of the enzyme removal procedure, as well as for a final release testing criteria. The Roche assays offer a broad measuring range suitable for in-process samples to bulk drug substances.
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