CMC Regulatory: Clinically relevant specifications: Case study and summary of discussion at BioPhorum Development Group meeting
The FDA's positions is that “Clinically relevant specifications can be defined as a set of criteria and acceptance ranges to which drug products should conform in order to deliver the therapeutic benefit indicated in the label.” and that “Clinically relevant specifications increase flexibility within the pharmaceutical manufacturing sector while maintaining quality by establishing acceptance criteria based on clinical relevance, instead of process capability or manufacturing process control.” The professionals in the BioPhorum CMC Regulatory team are aligned on the concept, but still have practical questions about what is expected. To address this they considered a case study concerning an mAb-X product and then survey the experience and discussed the positions of twenty four biopharma companies.
This 'Members Only' document captures the details of the case study and points of discussion between the companies. No views are attributable to any individual company.
This document was previously presented to:-
- CASSS CMC Strategy Forum, Washington DC, January 2019
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