Stuart R. Gallant, MD, PhD writes articles on topics related to pharmaceutical development and manufacturing at:
Regulatory resources are available through ICH:
CMC Working Group Antibody Case Study:
Papers:
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- Mehta, et al. ““Product on Stopper” in a Lyophilized Drug Product: Cosmetic Defect or a Product Quality Concern?” www.sciencedirect.com/science/article/abs/pii/S0022354918300753
- Ferrrante, S., et al. Test Process and Results of Potential Masking of Sterilizing-Grad Filters, PDA J Pharm Sci and Tech 2020, 74, 509-523. journal.pda.org/content/74/5/509
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