Stress Temperature Studies in Small Scale Hastelloy® Drug Substance Containers Lead to Increased Extent of and Increased Variability in Antibody-Drug Conjugate and Monoclonal Antibody Aggregation: Evidence for Novel Oxidation-Induced Crosslinking in Monoclonal Antibodies-Reference-Cited by-同舟云学术

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Stress Temperature Studies in Small Scale Hastelloy® Drug Substance Containers Lead to Increased Extent of and Increased Variability in Antibody-Drug Conjugate and Monoclonal Antibody Aggregation: Evidence for Novel Oxidation-Induced Crosslinking in Monoclonal Antibodies

Published:2021-04 Issue:4 Volume:110 Page:1615-1624
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Klair Nathaniel,Kim Michael T.,Lee Aron,Xiao Nina J.,Patel Ankit R.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference34 articles.

1. Corrosion in bioprocessing applications;Junker;Bioprocess Biosyst Eng,2009

2. Nickel Alloys;Heubner,2000

3. Stability Testing of New Drug Substances and Products Q1A(R2),2003

4. Pharmaceutical Stability,2012

5. A non-radioactive method for measuring Cu uptake in HepG2 cells;Fosset;J Inorg Biochem,2005

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

2. Identification of sorbitol esterification of glutamic acid by LC-MS/MS in a monoclonal antibody stability assessment;PLOS ONE;2024-05-02

3. Oxidation of polysorbates – An underestimated degradation pathway?;International Journal of Pharmaceutics: X;2023-12

4. Emerging Challenges and Innovations in Surfactant-mediated Stabilization of Biologic Formulations;Journal of Pharmaceutical Sciences;2021-12

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