Illuminating a biologics development challenge: systematic characterization of CHO cell-derived hydrolases identified in monoclonal antibody formulations-Reference-Cited by-同舟云学术

Illuminating a biologics development challenge: systematic characterization of CHO cell-derived hydrolases identified in monoclonal antibody formulations

Published:2024-07-10 Issue:1 Volume:16 Page:
ISSN:1942-0862
Container-title:mAbs
language:en
Short-container-title:mAbs

Author:

Maier Melanie¹²,Weiß Linus¹³,Zeh Nikolas¹,Schmieder-Todtenhaupt Valerie¹,Dehghani Alireza⁴,Felix Marius Nicolaus⁴,Heinzelmann Daniel¹,Lindner Benjamin¹,Schmidt Moritz¹,Studts Joey¹,Schulz Patrick¹,Reisinger Bernd⁴,Otte Kerstin³,Franzreb Matthias²,Lakatos Daniel¹,Fischer Simon¹

Affiliation:

1. Bioprocess Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany

2. Institute of Functional Interfaces, Karlsruhe Institute of Technology, Karlsruhe, Germany

3. Institute for Applied Biotechnology, University of Applied Sciences Biberach, Biberach an der Riss, Germany

4. Analytical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany

Funder

Boehringer Ingelheim

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/19420862.2024.2375798

Reference52 articles.

1. Polysorbate degradation in biotherapeutic formulations: Identification and discussion of current root causes

2. Kinetics of hydrolysis of polyoxyethylene (20) sorbitan fatty acid ester surfactants

3. Polysorbates 20 and 80 Used in the Formulation of Protein Biotherapeutics: Structure and Degradation Pathways

4. Edetate Disodium as a Polysorbate Degradation and Monoclonal Antibody Oxidation Stabilizer

5. Residual Host Cell Protein Promotes Polysorbate 20 Degradation in a Sulfatase Drug Product Leading to Free Fatty Acid Particles

Cited by 1 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. Systematic Optimization of Activity-Based Protein Profiling for Identification of Polysorbate-Degradative Enzymes in Biotherapeutic Drug Substance Down to 10 ppb;2024-08-30