Monoclonal antibodies have a more complicated structure than other therapeutic proteins, which can lead to challenges in meeting regulatory expectations. The EMA, FDA and USP (USP <129>) each have specific guidelines for the development and manufacture of monoclonal antibodies. However, they all adhere to the general principles set out in ICH Q6B, which specifies that antibodies must be well characterised in terms of physicochemical and structural properties, purity, impurities and biologic activity, binding activity and quantity.

RSSL offers analytical support to help you define your target product profile (TPP), and establish and then monitor critical quality attributes (CQA) so that you can ensure process changes are not detrimental to your product.

antibody analysisCritical Quality Attribute monitoring support offered by RSSL:

  • Peptide mapping for post translational modifications
    • Oxidation, deamidation, disulphide, trisulphide, C and N terminal variation
    • Intact and reduced mass (with or without deglycosylastion)
    • Glycan Analysis

RSSL scientists offer work packages for every aspect of your antibody characterisation at all stages in the product lifecycle, from analysis and support for clone selection in early stage discovery and development, through stability determination using forced degradation, to method validation of final release assays. We also offer support for comparability testing to ensure product consistency as well as Qualified Person (QP) training for lot release and beyond.

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