Analytical Quality by Design as applied to the development of a SEC-HPLC platform procedure for the determination of monoclonal antibody purity without mobile phase additives-Reference-Cited by-同舟云学术

Analytical Quality by Design as applied to the development of a SEC-HPLC platform procedure for the determination of monoclonal antibody purity without mobile phase additives

Published:2024-08 Issue: Volume:246 Page:116220
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Cernosek Terezie,Dalphin Matthew,Jain Nitin,Richter Noah,Beard Spencer,Wang Jianlin,Osborne Joe,Stone Todd,Mellal Mourad,Behrens Sue,Wunderli Peter

Publisher

Elsevier BV

Reference35 articles.

1. Characterizing biological products and assessing comparability following manufacturing changes;Chirino;Nat. Biotechnol.,2004

2. International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use;Tietje,2010

3. Determination of critical quality attributes for monoclonal antibodies using quality by design principles;Alt;Biologicals,2016

4. S. Fekete, J.-L. Veuthey, D. Guillarme, Modern Column Technologies for the Analytical Characterization of Biopharmaceuticals in Various Liquid Chromatographic Modes, (2015) 8.

5. Unraveling the mysteries of modern size exclusion chromatography - the way to achieve confident characterization of therapeutic proteins;Goyon;J. Chromatogr. B,2018

Cited by 2 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. Application of Analytical Quality by Design to the development and validation of reduced and non-reduced capillary electrophoresis analytical procedures for mAb purity determination;Journal of Pharmaceutical and Biomedical Analysis;2024-10

2. A case study application of AQbD to the re-development and validation of an affinity chromatography analytical procedure for mAb titer quantitation;Journal of Chromatography B;2024-07