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PDA Comments on ICH Q9-1 (pdf)

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PDA Comments on Guideline on Production and Quality Control of Monoclonal Antibodies and Related Substances (pdf)

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EU Commission Draft Template on GMPCompliance of Investigational Medicinal Products Manufactured in Non-EU Countries 2 Apr 2013 (pdf)

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FDA Draft Guidance on ICHQ11 Development and Manufacture of Drug Substances 1 Sep 2011 (pdf)

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Reference 2 - FDA Expected CMC Content in BLA 1996 (pdf)

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