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Compliance Notice All information is provided strictly for educational and research purposes

doi: 10.1007/s00705-006-0880-2 85 ZhangK.ShenY.WangT.WangY.XueS.LuanH.et al

pii: E2799

Downstream GMP quality control must further include predefined critical quality attributes (CQAs), encompassing particle size distribution, particle-to-protein ratios, sterility, endotoxin levels, residual contaminants (e.g., pesticides and heavy metals), and stability during storage, consistent with Chemistry, Manufacturing, and Controls (CMC) expectations for investigational new drug (IND) applications