Bechtold-Peters, Karoline (2022) 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. Journal of pharmaceutical sciences, 111 (5). pp. 1280-1291. ISSN 00223549

Abstract

Polysorbates (PS) are widely used as a stabilizer in biopharmaceutical products. Industry practices on various aspects of PS are presented in this part 1 survey report based on a confidential survey and following discussions by 16 globally acting major biotechnology companies. The current practice and use of PS during manufacture across their global manufacturing sites are covered in addition to aspects like current understanding of the (in)stability of PS, the routine QC testing and control of PS, and selected regulatory aspects of PS. The results of the survey and extensive cross-company discussions are put into relation with currently available scientific literature. Part 2 of the survey report (upcoming) will focus on understanding, monitoring, prediction, and mitigation of PS degradation pathways to develop an effective control strategy.

Item Type:	Article
Keywords:	Biological Products Excipients Polysorbates
Date Deposited:	15 Jun 2022 00:45
Last Modified:	15 Jun 2022 00:45
URI:	https://oak.novartis.com/id/eprint/46526