Analytical Strategies for Comparability in Bioprocess Development
Posted on August 24, 2016
By: Christine P. Chan, Ph.D.
Principal Scientist, Global Manufacturing Science & Technology, Specialty Care Operations
Sanofi
Introduction Comparability exercises are commonly required at certain milestones during drug development as well as after product registration when changes are implemented into the manufacturing process. These comparability studies are performed according to principles described in ICH guidance docu...
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Related Topics and Keywords
biopharmaceutical development, Chemical degradation includes peptide backbone fragmentation, Christine P. Chan, Comparability In Bioprocess Development, comparability strategy, CQA, critical quality attribute, deamidation, disulfide rearrangement. integrated control strategy, Global Manufacturing Science & Technology, glycation, higher order structures, HOS, ICH guidance, ICH Q8, isomerization, N-terminal cyclization, oxidation, PK/PD, protein-based therapeutics, QbD, Quality by Design, racemization, SAR, Structure and activity relationship
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