Polysorbate Degradation and Particle Formation in a High Concentration mAb: Formulation Strategies to Minimize Effect of Enzymatic Polysorbate Degradation-Reference-Cited by-同舟云学术

Polysorbate Degradation and Particle Formation in a High Concentration mAb: Formulation Strategies to Minimize Effect of Enzymatic Polysorbate Degradation

Published:2021-09 Issue:9 Volume:110 Page:3313-3323
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Roy Ian,Patel Ashaben,Kumar Vineet,Nanda Tatiana,Assenberg Rene,Wuchner Klaus,Amin Ketan

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference39 articles.

1. Purification of antibodies using affinity chromatography;Darcy;Methods Mol Biol,2017

2. Identification of subvisible particles in biopharmaceutical formulations using raman spectroscopy provides insight into polysorbate 20 degradation pathway;Saggu;Pharm Res,2015

3. Ester hydrolysis of polysorbate 80 in mAb drug product: evidence in support of the hypothesized risk after the observation of visible particulate in mAb formulations;Labrenz;J Pharm Sci,2014

4. Effective strategies for host cell protein clearance in downstream processing of monoclonal antibodies and Fc-fusion proteins;Li;Protein Expr Purif,2017

5. Knockout of a difficult-to-remove CHO host cell protein, lipoprotein lipase, for improved polysorbate stability in monoclonal antibody formulations;Chiu;Biotechnol Bioeng,2017

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