Glycans as critical quality attributes of therapeutic antibodies
Journal of Glycobiology

Journal of Glycobiology
Open Access

ISSN: 2168-958X

+44 20 3868 9735

Glycans as critical quality attributes of therapeutic antibodies

3rd Glycobiology World Congress

June 26-28, 2017 London, UK

Christoph Roesli

Novartis Pharma AG, Switzerland

Posters & Accepted Abstracts: J Glycobiol

Abstract :

The identification of critical quality attributes (CQAs) of therapeutic antibodies is of key importance during product development. Distinct product-related variants originating from the manufacturing process or formed during storage have to be assessed regarding their bioactivity/potency, PK/PD, immunogenicity and safety. Here we present an overview on the influence of glycan structures of IgG molecules on both, their biological activity and on pharmacokinetics. Importantly, the antibody isotype as well as the antigen localization have to be considered when evaluating the glycosylation variants on the Fc part of IgGs. Depending on the primary mode of action and/or additional modes of action, N-linked glycans attached to the Fc part can significantly influence the biological activity of a therapeutic antibody. This is one reason for extensive research on glycosylation modification. In addition to N-linked glycans, glycation during the manufacturing process as well as oligosaccharides present on non-consensus amino acid sequences are discussed. Having a complete data set on both the glycan structures of an antibody and of the potential glycation sites allows for an assessment of the criticality of sugar variants regarding biological activity and pharmacokinetics.

Biography :

Email: [email protected]