Aga,
Limits for residual impurities can vary based on the stage of vaccine development. For earlier phases, limits can be wider based on limited manufacturing/purification experience. In my experience, I've dealt with products where we used affinity chromatography using Protein A. limits were around 30-50 ng/mg of protein throughout the product development. limits were based upon purification capability, assay capability and manufacturing experience. similar assessment should be carried out with affinity chromatography using his-tagged proteins to establish limits.
Enclosed is a presentation from FDA in CASSS seminar focused on process-related impurities. very informative.
Hope this helps.
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Deep Shah
Regulatory Affairs CMC, Biologics
Seattle WA
United States
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Original Message:
Sent: 29-Apr-2020 14:48
From: Aga Szydlik
Subject: acceptance criteria for his-tag proteins
Hi,
Is there a reference for specifications on his-tags proteins (residual impurities) in a pharmaceutical (mRNA vaccine, IM ). Also if anyone knows good guidance /references on process-related impurities I would be very appreciative.
THANK YOU