A Retrospective Evaluation of the Use of Mass Spectrometry in FDA Biologics License Applications-Reference-Cited by-同舟云学术

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

Published:2016-11-21 Issue:5 Volume:28 Page:786-794
ISSN:1044-0305
Container-title:Journal of the American Society for Mass Spectrometry
language:en
Short-container-title:J. Am. Soc. Mass Spectrom.

Author:

Rogstad Sarah¹,Faustino Anneliese¹,Ruth Ashley²,Keire David¹,Boyne Michael²,Park Jun³

Affiliation:

1. Division of Pharmaceutical Analysis, Office of Testing and Research, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 20993, Silver Spring, MD, USA

2. Biotechlogic, Inc., 60025, Glenview, IL, USA

3. Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 20993, Silver Spring, MD, USA

Publisher

American Chemical Society (ACS)

Subject

Spectroscopy,Structural Biology

Link

http://link.springer.com/content/pdf/10.1007/s13361-016-1531-9.pdf

Reference26 articles.

1. EvaluatePharma: World Preview 2015, Outlook to 2020, 8th ed. (2015)

2. Applications of mass spectrometry for the structural characterization of recombinant protein pharmaceuticals

3. Morrow, T.: Defining the difference: what makes biologics unique. Biotechnology Healthcare (2004)

4. Post-translational structural modifications of immunoglobulin G and their effect on biological activity

5. Structure-Immunogenicity Relationships of Therapeutic Proteins

Cited by 97 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Implementation of a LC-MS based multi-attribute method (MAM) and intact multi-attribute method (iMAM) workflow for the characterisation of a GLP-Fc fusion protein;Analytical Biochemistry;2024-10

2. Characterization of Therapeutic Antibody Charge Heterogeneity Under Stress Conditions by Microfluidic Capillary Electrophoresis Coupled with Mass Spectrometry;Journal of Pharmaceutical Sciences;2024-08

3. Targeted CQA analytical control strategy for commercial antibody products: Replacing ion-exchange chromatography methods for charge heterogeneity with multi-attribute monitoring;mAbs;2024-04-23

4. Exposing the molecular heterogeneity of glycosylated biotherapeutics;Nature Communications;2024-04-16

5. Assessment of monoclonal antibody glycosylation: a comparative study using HRMS, NMR, and HILIC-FLD;Analytical and Bioanalytical Chemistry;2024-04-06