The calculation of cleaning carryover limits in multi-product facilities can be based on the inactivity of molecules after exposure to cleaning conditions if the inactivation of active molecules can be demonstrated. The demonstration of inactivation has been addressed in several publications that have shown degradation and/or denaturation using different analytical techniques such as sodium dodecyl sulfate-polyacrylamide gel electrophoresis and enzyme-linked immunosorbent assay, which directly or indirectly demonstrate that the product residue is no longer active. In this paper, authors expand the assay options by demonstrating the use of molecule-specific cell-based activity assays, which provide a “catch all” measurement of sample bioactivity, to assess the inactivation of therapeutic antibodies after exposure to cleaning conditions.
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