A–Mab: A Case Study in Bioprocess Development

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a-mab-case-study-version.pdf (4.38 MB)

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https://ispe.org/publications/guidance-documents/a-mab-case-study-in-bioprocess-development

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http://hdl.handle.net/11603/33670

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UMBC Biotechnology at Shady Grove

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Date

2009-10-30

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reports
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Citation of Original Publication

CMC Work Group Consortium. "A–Mab: A Case Study in Bioprocess Development". ISPE (October 2009). https://ispe.org/publications/guidance-documents/a-mab-case-study-in-bioprocess-development

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Abstract

This is a detailed case study to stimulate discussion around how the core principles contained in Q8(R2), Q9 and Q10 guidelines could be applied to product realisation programs for a biotechnology-derived monoclonal antibody.