Enzymes such as Trypsin and Collagenase are often critical components for product processing, modification of proteins and cell preparation for stem cell therapies. As these final cell-based products are intended for administration into patients, it is important that any residual enzyme material from the production process be assessed and its final concentration minimized to reduce risk. Potential negative impacts of residual enzymes could include immunogenic activity, reduced efficacy of the final product, and toxicity in patients. Although there are no specific regulatory guidelines at this time to specify allowable amounts of residual Trypsin or Collagenase, these are still considered process residuals and potential product contaminants, and thus should be assessed as part of an overall risk mitigation strategy.
While activity assays are often used to verify removal of residual enzymes, these have limited sensitivity and may only provide partial information as they will only detect active enzyme, while missing inactive fragments that might still be immunogenic. ELISA technology that is independent from activity is a favorable alternative for detecting residual enzymes such as Trypsin and Collagenase.