Following a review of the Analytical method bridging benchmarking survey results, key messages appear to be that:
- Bridging approaches differ from company to company
- There seems to be a lack of a harmonized approach outside of the commercial setting.
The team feel there is a gap in this area that needs a standardized perspective, particularly in the pre-BLA space. A smaller group within the workstream have performed a literature review and are currently performing a gap analysis to ascertain if a guidance paper would be beneficial and what the scope of this would be.