Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates-Reference-Cited by-同舟云学术

Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates

Published:2022-05 Issue:5 Volume:111 Page:1280-1291
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Wuchner Klaus^ORCID,Yi Linda,Chery Cyrille^ORCID,Nikels Felix,Junge Friederike,Crotts George^ORCID,Rinaldi Gianluca,Starkey Jason A.,Bechtold-Peters Karoline^ORCID,Shuman Melissa,Leiss Michael,Jahn Michael,Garidel Patrick^ORCID,de Ruiter Rien^ORCID,Richer Sarah M,Cao Shawn^ORCID,Peuker Sebastian,Huille Sylvain,Wang Tingting,Le Brun Virginie

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference73 articles.

1. Presentation “multi-company survey on the use and characterization of polysorbates in biotech products”;Wuchner,2020

2. A review of formulations of commercially available antibodies;Strickley;J Pharm Sci,2021

3. FDA inactive ingredients database; PS20. https://fda.report/UNII/7T1F30V5YH, PS80 https://fda.report/UNII/6OZP39ZG8H (both accessed December 8, 2021)

4. Pediatric safety of polysorbates in drug formulations;Kriegel;Children (Basel),2019

5. Parenteral protein formulations: an overview of approved products within the European Union;Gervasi;Eur J Pharm Biopharm,2018

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3. How enzymatic hydrolysis of polysorbate 20 influences colloidal protein stability;European Journal of Pharmaceutical Sciences;2023-12

4. Oxidation of polysorbates – An underestimated degradation pathway?;International Journal of Pharmaceutics: X;2023-12

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