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Ask The Expert - At what stage(s) of the production cycle should you test for residual enzymes?

Published: June 16, 2016
Session Expert: Roger Noble, Roche Custom Biotech



At what stage(s) of the production cycle should you test for residual enzymes?

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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