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mAbs Volume 8, 2016 - Issue 8
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Perspective

Quality by Design risk assessments supporting approved antibody products

Brian KelleyGenentech, South San Francisco, CA, USACorrespondence[email protected]
Pages 1435-1436 | Received 31 Aug 2016, Accepted 31 Aug 2016, Published online: 13 Oct 2016

References

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  • Food and Drug Administration BLA Market Approval Letter for Gazyva http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125486Orig1s000Approv.pdf
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  • Kelley B. Industrialization of mAb production technology: The bioprocessing industry at a crossroads. Mabs 2009; 1:443-452; PMID:20065641; http://dx.doi.org/10.4161/mabs.1.5.9448

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