Whitepaper: Tips to improve SEC for mAbs and ADCs
Posted: 3 December 2020 | Merck | No comments yet
Practical Tips for Monomer/Aggregate and Fragment Content Monitoring of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs).
Product characterization is the essential foundation for successful biological drug development. Understanding the chemistry, structure, and biological activities ensures QC will measure critical product safety, purity, and potency attributes, as per ICH Q6B.
In this article, published originally in American Pharmaceutical Review, we explore tips to improving the method of Size Exclusion Chromatography (SEC) which is often used to measure monomer/aggregate and fragment content of mAbs and ADCs.
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Analytical techniques, Biopharmaceuticals, Formulation, Labelling, Manufacturing, Packaging, QA/QC, Regulation & Legislation, Research & Development (R&D)
