The Use of Mass Spectrometry in Therapeutic Protein Biologics License Applications: A Retrospective Review Revisited-Reference-Cited by-同舟云学术

The Use of Mass Spectrometry in Therapeutic Protein Biologics License Applications: A Retrospective Review Revisited

Published:2023-10-16 Issue:11 Volume:34 Page:2575-2584
ISSN:1044-0305
Container-title:Journal of the American Society for Mass Spectrometry
language:en
Short-container-title:J. Am. Soc. Mass Spectrom.

Author:

Mans Jamie¹,Oyugi Mercy²,Asmelash Bethel¹,Sommers Cynthia¹,Rogstad Sarah²^ORCID

Affiliation:

1. Division of Complex Drug Analysis, Office of Testing and Research, Center for Drug Evaluation and Research, US Food and Drug Administration, St Louis, Missouri 63110, United States

2. Immediate Office, Office of Testing and Research, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, United States

Funder

U.S. Food and Drug Administration

U.S. Department of Energy

Publisher

American Chemical Society (ACS)

Subject

Spectroscopy,Structural Biology

Link

https://pubs.acs.org/doi/pdf/10.1021/jasms.3c00286

Reference15 articles.

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2. U.S. Food and Drug Administration. Priority NDA and BLA Approvals; 2023. https://www.fda.gov/drugs/nda-and-bla-approvals/priority-nda-and-bla-approvals

3. The role of mass spectrometry in the characterization of biologic protein products

4. A Retrospective Evaluation of the Use of Mass Spectrometry in FDA Biologics License Applications

5. Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review

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