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Removal of headspace alone reduced diNAC formation from 76.5% to 34.9% in aerobic stocks after 2 weeks (Fig

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mock dosing with isotonic saline

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