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Mitigation of Protein Artifact Oxidations During HPLC Peak Fractionation Process Logo
  • Abstract
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Company Biography

Therapeutic monoclonal antibodies (mAbs) are inherently heterogeneous and hence generally studied and controlled by an array of orthogonal separation methods. During drug candidate development, fractionation by HPLC is regularly employed to assist peak identification and product understanding. One overlooked challenge is the protein oxidation introduced by the fractionation process. In this study, we report the extent of experimentally introduced protein oxidation, which tends to complicate data interpretation and peak assignments. Higher-energy detectors such as fluorescence detectors, lower fraction concentration, and lower salt concentration in elution solvent were found to exacerbate the oxidation artifacts. The buffer exchange and concentration steps after fraction collection were also found to contribute significantly to protein oxidation. Furthermore, our study showed that collecting fractions into a solution with protecting reagents, such as histidine and methionine, was effective in eliminating the oxidation artifacts introduced by detector exposure and fraction processing steps. Through an example, we demonstrate that the modified fractionation workflow described here improves the accuracy of peak assignments.

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Name
Ben Niu

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Team Members

Ben Niu profile image

Ben Niu

AstraZeneca

Presenter
Ben Niu
AstraZeneca
Email: ben.niu1@astrazeneca.com
Chunlei Wang profile image

Chunlei Wang

AstraZeneca

Co-Author
Chunlei Wang
AstraZeneca
Email: Chunlei.Wang1@astrazeneca.com
Michael Martinelli profile image

Michael Martinelli

AstraZeneca

Co-Author
Michael Martinelli
AstraZeneca
Email: Michael.martinelli@astrazeneca.com
Niluka de Mel profile image

Niluka de Mel

AstraZeneca

Co-Author
Niluka de Mel
AstraZeneca
Email: niluka.demel@astrazeneca.com
Wei Xu profile image

Wei Xu

AstraZeneca

Co-Author
Wei Xu
AstraZeneca
Email: wei.xu@astrazeneca.com