Analytical method bridging study strategy survey

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.

This document is reserved for the use of BioPhorum members only.

I don't have access to this document

Make a selection below and submit your request. We will get back to you ASAP.

My company would like to become a member

If you're not sure if your company is a member of this Phorum, or if you would like to enquire on behalf of your company about becoming a member, please see our membership page.