Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future-Reference-Cited by-同舟云学术

Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future

Published:2022-11 Issue:11 Volume:111 Page:2955-2967
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,Brun Virginie Le

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference82 articles.

1. 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;Wuchner;J Pharm Sci,2022

2. Understanding the composition and quality of polysorbates to strengthen USP– NF compendial standards;Moore;USP PF Stimuli Art,2021

3. Excipients and Biotechnology Product Quality Attributes: A Regulator's Perspective on Reducing the Interfacial Tension;Rao,2020

4. 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

5. polysorbates 20 and 80 degradation by Group XV lysosomal phospholipase A2 Isomer X1 in monoclonal antibody formulations;Hall;J Pharm Sci,2016

Cited by 23 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. Feasibility of Laboratory Equipment-Based Simulation Methods to Assess the Impact of Vehicle Transportation on Product Quality of mAb Dosing Solutions;Molecular Pharmaceutics;2024-08-14

2. Stability of Protein Pharmaceuticals: Recent Advances;Pharmaceutical Research;2024-06-27

3. Monitoring polysorbate 80 degradation in protein solutions using Total Holographic Characterization;International Journal of Pharmaceutics;2024-03

4. Correlating Surface Activity with Interface-Induced Aggregation in a High-Concentration mAb Solution;Molecular Pharmaceutics;2024-02-22

5. Using Passive Microrheology to Measure the Evolution of the Rheological Properties of NIST mAb Formulations during Adsorption to the Air–Water Interface;Langmuir;2024-02-21