Development of Glycoanalytical Methods for Characterization of Biosimilar Monoclonal Antibodies
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Type of Work111 Pages
Citation of Original PublicationKashi L, Yandrofski K, Preston RJ, Arbogast LW, Giddens JP, Marino JP, Schiel JE, Kelman Z. 2018. Heterologous recombinant expression of non-originator nistmab. mAbs. 10(6):922-933.
Monoclonal antibodies are the fastest growing class of therapeutics with more than $100 billion in yearly revenue. Many of the world’s top selling biotherapeutic mAbs will lose their patent protection by the end of 2019 and a large number of biosimilars are emerging. Detailed characterization of physiochemical and biophysical attributes, such as glycosylation and aggregation, are of critical importance to their safety and efficacy are critical to establishing analytical similarity. Herein we describe development of three analytical assays; size exclusion chromatography (SEC), intact mass spectrometry, and released glycan analysis using the NISTmAb Reference Material – an open innovation tool for the development of innovative analytical approaches. These analytical methods were then applied to a series of non-originator cell lines expressing the NISTmAb that were developed as a pre-competitive biosimilarity test case. The analytical methods and dataset provide the foundational infrastructure for continued development of this resource for the biopharmaceutical community.