Kinetics and Characterization of Non-enzymatic Fragmentation of Monoclonal Antibody Therapeutics

Kinetics and Characterization of Non-enzymatic Fragmentation of Monoclonal Antibody Therapeutics Pharm Res (2018) 35: 142 https://doi.org/10.1007/s11095-018-2415-4 RESEARCH PAPER Kinetics and Characterization of Non-enzymatic Fragmentation of Monoclonal Antibody Therapeutics 1 1 1 1 Sahithi Ravuluri & Rohit Bansal & Nidhi Chhabra & Anurag S. Rathore Received: 5 July 2017 /Accepted: 22 April 2018 /Published online: 14 May 2018 # Springer Science+Business Media, LLC, part of Springer Nature 2018 ABSTRACT results are expected to assist end users in formulation devel- Purpose To understand non-enzymatic hydrolytic fragmen- opment as well as in monitoring stability of biotherapeutic tation of a monoclonal antibody therapeutic under tempera- products. ture stressed conditions and investigating possible mechanism for the same. . . KEY WORDS fragmentation kinetic modeling mass Methods The mAb therapeutic was incubated at 50°C in . . spectrometry monoclonal antibodies size exclusion phosphate buffer at pH 6.5 and fragmentation was monitored chromatography at different ionic strengths under stressed conditions. The in- cubated mAb was sampled at regular time intervals by ana- lytical Size Exclusion Chromatography (SEC). Results It was observed that 57% of the mAb product frag- ABBREVIATIONS mented over 4 days into two fragment species – Fc-Fab and DAD Diode array detector Fab with molecular weights of 97 KDa and 47 KDa, respec- DLS http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Pharmaceutical Research Springer Journals

Kinetics and Characterization of Non-enzymatic Fragmentation of Monoclonal Antibody Therapeutics

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Publisher
Springer US
Copyright
Copyright © 2018 by Springer Science+Business Media, LLC, part of Springer Nature
Subject
Biomedicine; Pharmacology/Toxicology; Pharmacy; Biochemistry, general; Medical Law; Biomedical Engineering
ISSN
0724-8741
eISSN
1573-904X
D.O.I.
10.1007/s11095-018-2415-4
Publisher site
See Article on Publisher Site

Abstract

Pharm Res (2018) 35: 142 https://doi.org/10.1007/s11095-018-2415-4 RESEARCH PAPER Kinetics and Characterization of Non-enzymatic Fragmentation of Monoclonal Antibody Therapeutics 1 1 1 1 Sahithi Ravuluri & Rohit Bansal & Nidhi Chhabra & Anurag S. Rathore Received: 5 July 2017 /Accepted: 22 April 2018 /Published online: 14 May 2018 # Springer Science+Business Media, LLC, part of Springer Nature 2018 ABSTRACT results are expected to assist end users in formulation devel- Purpose To understand non-enzymatic hydrolytic fragmen- opment as well as in monitoring stability of biotherapeutic tation of a monoclonal antibody therapeutic under tempera- products. ture stressed conditions and investigating possible mechanism for the same. . . KEY WORDS fragmentation kinetic modeling mass Methods The mAb therapeutic was incubated at 50°C in . . spectrometry monoclonal antibodies size exclusion phosphate buffer at pH 6.5 and fragmentation was monitored chromatography at different ionic strengths under stressed conditions. The in- cubated mAb was sampled at regular time intervals by ana- lytical Size Exclusion Chromatography (SEC). Results It was observed that 57% of the mAb product frag- ABBREVIATIONS mented over 4 days into two fragment species – Fc-Fab and DAD Diode array detector Fab with molecular weights of 97 KDa and 47 KDa, respec- DLS

Journal

Pharmaceutical ResearchSpringer Journals

Published: May 14, 2018

References

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