Product Quality Assessment using N-linked Glycan Analysis by LC-MS Supports Identification of Commercially Viable Cell lines for Biopharmaceuticals

BPI Contributor

November 3, 2015

20 Min View
Product Quality Assessment using N-linked Glycan Analysis by LC-MS Supports Identification of Commercially Viable Cell lines for Biopharmaceuticals

Date: Nov 3, 2015

Duration: 20 Min

This webcast features: Gareth Meek-Brown, Lead Scientist, Lonza Biologics – Slough

Product Quality assessment during Upstream and Downstream Process Development is key to the production of safe and efficacious biopharmaceuticals.

Critical quality attributes such as N-linked glycosylation are highly dependent upon biosynthesis conditions and play a crucial role in the pharmacology of therapeutic proteins, potentially affecting immunogenicity, pharmacokinetics and pharmacodynamics.

The presence of N-linked glycosylation has benefits including increased thermal, physical and chemical stability over aglycosylated variants. The optimum N-linked glycosylation profile will depend on the desired target effect of the therapeutic protein in question. The effect glycosylation has on biopharmaceutical activity highlights the need to identify glycosylation expression during process development where expression can be altered.

N-linked and O-linked are the most common types of glycosylation. In this webinar we present the use of High Throughput N-linked glycosylation sample preparation and analysis by LC-MS to screen high numbers of potential clones for cell line selection and upstream process development.



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