hplc-analytical-chem-2018-posters-abstracts

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Journal of Analytical & Bioanalytical Techniques | ISSN: 2155-9872 | Volume 9

World HPLC, Separation Techniques & Pharmacovigilance

World Analytical Chemistry & Mass Spectrometry

International Conference on

August 29-30, 2018 | Toronto, Canada

Platform Size Exclusion Chromatography (SEC) method development for a broad range of

monoclonal antibodies

Isil Yasa, Vandana Chandrasekar, Michael Adamo, Amit Katiyar, Tapan Das

and

Ryan Knihtila

Bristol-Myers Squibb, USA

nderstanding of size heterogeneity in biotherapeutic proteins is essential since it is one of the Critical Quality Attributes

(CQA) due to its impact on safety and efficacy. The size heterogeneity covers the product related species/impurities

that includes fragments, monomers and aggregates. Size exclusion chromatography (SEC) has been widely used to separate

aggregates, monomer and fragments of monoclonal antibodies (mAbs) that might form during manufacturing, storage and

shipping. The progress in biologics pipeline and the urgency to reach first-in-human (FIH) has provided an opportunity to

develop a generic method that can serve as a platform method for monoclonal antibodies. This study describes platform

SEC method development for monoclonal antibodies using commercially available highperformance liquid chromatography

(HPLC) and ultra-performance liquid chromatography (UPLC) SEC columns. For this purpose, several antibodies covering a

broad range of isoelectric points (pI) and hydrophobicity were analyzed. Initial comparison was performed using six different

mAbs to understand the impact of mobile phase and organics on separation of aggregates and fragments.

Isil Yasa et al., J Anal Bioanal Tech 2018, Volume 9

DOI: 10.4172/2155-9872-C1-028