5. How does the ICH M10 affect bioanalytical outsourcing?

Ask the Experts Regulated bioanalysis

Mark Arnold (left) and Rob Nelson (right) (Labcorp)

ICH M10 is expected to add some requirements to current practices and CROs will have to quickly respond and adapt their procedures.  Rapid adopters may see more business as clients will not want work performed that is not compliant with M10.

A real benefit may occur If the pharma sponsor agrees that they have no customizations to the procedures for method validation or sample analysis and the resulting reports, then standardized approaches can be implemented. This improves CRO efficiency and speed, a benefit to client and CRO alike.

 Kelly Dong (United-Power Pharma Tech Co., Ltd.,)

The implementation of ICH M10 could enable global harmonization and provide a common understanding among bioanalytical community, thereby, it will benefit bioanalytical outsourcing by streamlining the method evaluation process and simplifying method transfer. In particular, several recommendations on stability assessments are much appreciated for bioanalytical outsourcing, including clarification on whether to repeat the established stability data, the stability extrapolation at one temperature (e.g. -20°C) to lower temperature for chemical drugs and a bracketing approach for biological drugs.

The opinions expressed in this feature are those of the authors and do not necessarily reflect the views of Bioanalysis Zone or Future Science Group.