Host cell protein profiling of commercial therapeutic protein drugs as a benchmark for monoclonal antibody-based therapeutic protein development-Reference-Cited by-同舟云学术

Host cell protein profiling of commercial therapeutic protein drugs as a benchmark for monoclonal antibody-based therapeutic protein development

Published:2021-01-01 Issue:1 Volume:13 Page:
ISSN:1942-0862
Container-title:mAbs
language:en
Short-container-title:mAbs

Author:

Molden Rosalynn¹,Hu Mengqi¹,Yen E Sook¹,Saggese Diana¹,Reilly James²,Mattila John²,Qiu Haibo¹^ORCID,Chen Gang³,Bak Hanne²^ORCID,Li Ning¹

Affiliation:

1. Analytical Chemistry, Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA

2. Preclinical Manufacturing and Process Development, Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA

3. Protein Expression Sciences, Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA

Publisher

Informa UK Limited

Subject

Immunology,Immunology and Allergy

Link

https://www.tandfonline.com/doi/pdf/10.1080/19420862.2021.1955811

Reference48 articles.

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2. European Pharmacopoeia Monograph 2.6.34.Host-cell protein assays (04/2017:20634).

3. U.S. Pharmacopeia <1132> Residual host cell protein measurement in biopharmaceuticals. USP39-NF34, 2016.

4. Points to consider in the manufacture and testing of monoclonal antibody products for human use. In: FDA, ed. FDA-1994-D-0318. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/points-consider-manufacture-and-testing-monoclonal-antibody-products-human-use, 1997.

5. DNA and host cell protein impurities, routine testing versus validation studies. In: EMA, ed. CPMP/BWP/382/97. www.ema.europa.eu/en/dna-host-cell-protein-impurities-routine-testing-versus-validation-studies, 1997.

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