Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development-Reference-Cited by-同舟云学术

Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development

Published:2023-05-22 Issue:1 Volume:15 Page:
ISSN:1942-0862
Container-title:mAbs
language:en
Short-container-title:mAbs

Author:

Guo Jia¹,Kufer Regina²,Li Delia¹,Wohlrab Stefanie²,Greenwood-Goodwin Midori³,Yang Feng¹

Affiliation:

1. Protein Analytical Chemistry, Genentech, A Member of the Roche Group, South San Francisco, CA, USA

2. Pharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, Germany

3. Biological Technologies, Genentech, A Member of the Roche Group, South San Francisco, CA, USA

Funder

there is no funding

Publisher

Informa UK Limited

Subject

Immunology,Immunology and Allergy

Link

https://www.tandfonline.com/doi/pdf/10.1080/19420862.2023.2213365

Reference116 articles.

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2. FDA. Points to consider in the manufacture and testing of monoclonal antibody products for human use. FDA-1994-D-0318 1994.

3. EMA. DNA and host cell protein impurities routine testing versus validation studies. 1997; CPMP/BWP/382/97.

4. Residual host cell protein measurement in biopharmaceuticals;Pharmacopeia US.;USP,2016

5. Host-cell protein assays;Pharmacopeia EU;European pharmacopoeia monograph 2.6.34.,2017

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