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
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.