Assessment of Structural and Functional Comparability of Biosimilar Products: Trastuzumab as a Case Study-Reference-Cited by-同舟云学术

Assessment of Structural and Functional Comparability of Biosimilar Products: Trastuzumab as a Case Study

Published:2020-01-23 Issue:2 Volume:34 Page:209-223
ISSN:1173-8804
Container-title:BioDrugs
language:en
Short-container-title:BioDrugs

Author:

Joshi Srishti,Rathore Anurag S.^ORCID

Funder

Department of Biotechnology , Ministry of Science and Technology

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Link

http://link.springer.com/content/pdf/10.1007/s40259-020-00404-3.pdf

Reference41 articles.

1. DBT & CDSCO. Guidelines on similar biologics 2016 Guidelines on similar biologics : regulatory requirements for market authorization in India. 2016.

2. Rathore AS. Follow-on protein products: scientific issues, developments, and challenges. Compr Biotechnol 2011:521–9.

3. Batra J, Rathore AS. Glycosylation of monoclonal antibody products: Current status and future prospects. Biotechnol. Prog. 2016. pp. 1091–102.

4. Beck A, Wurch T, Reichert JM. 6th annual European antibody congress 2010: November 29–December 1, 2010, Geneva, Switzerland. mAbs. 2011;3:111–32.

5. Committee for medicinal products for human use (CHMP) guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. 2006. http://www.ema.europa.eu. Accessed 05 May 2019.

Cited by 31 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

2. Assessment of change in the basic variants composition of trastuzumab during dilution in saline for administration;European Journal of Pharmaceutics and Biopharmaceutics;2024-06

3. Machine learning tool as an enabler for rapid quantification of monoclonal antibodies N-glycans using fluorescence detector;International Journal of Biological Macromolecules;2024-06

4. LC–MS Characterization and Stability Assessment Elucidate Correlation Between Charge Variant Composition and Degradation of Monoclonal Antibody Therapeutics;The AAPS Journal;2024-04-03

5. Impact of Excipient Extraction and Buffer Exchange on Recombinant Monoclonal Antibody Stability;Molecular Pharmaceutics;2024-02-29