Monoclonal antibodies (mAbs) are of huge pharmaceutical significance because they can be specifically designed to effectively target critical pathogenic molecules and therefore modulate the natural course of serious disease. Produced by cell culture, however, mAbs contain numerous variants and may also contain dimers and higher order aggregates. This is problematic and can be highly detrimental to the efficacy and safety as well as impacting production yield.
Although there is an intense focus on product quality and consistency throughout mAb production, both upstream during expression or downstream during purification, minimising aggregation remains a primary concern. This has ensured that novel analytical workflows that allow batch quality to be rapidly and reliably confirmed are of huge interest and economic value.
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In this webinar we will present details of a complete aggregate analysis workflow that couples multiple analytical techniques to provide an efficient and reliable measure of mAb aggregation – all the way from a simple, non-destructive measurement that provides a qualitative indication if a sample is aggregated or not through to techniques that accurately quantify dimers and higher order aggregates, and which deliver greater insights into the protein.
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Speakers
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Dr. Kevin Grant, Ph. D.,
Molecular Spectroscopy Product Manager,
Agilent Technologies
Dr. Andrew Coffey, Ph.D.,
Applications Chemist,
Agilent Technologies
Britt Erikson,
Senior Editor,
C&EN