Bispecific antibody characterisation services supporting regulatory considerations for therapeutic development.

Bispecific antibody (BsAb) characterisation and analysis is key to development of this therapeutic class. The activity, efficacy and immunogenicity of a BsAb is influenced by its molecular structure and properties, which by their very nature, can be complex. Characterization programs require multiple analytical approaches to assess all expected properties in line with ICH guidelines.

Bispecific antibodies, comprise of the binding of at least two antigen binding elements within one single bispecific antibody. Many bispecific formats exist and therefore understanding and control of key critical quality attributes (CQAs)) including structure, potency, process-related impurities, chain mis-matching/fragments/homodimers, stability, antigen specificity, affinity and on-off rates and avidity need to be demonstrated in accordance with regulatory guidelines.

Bispecific Antibody Characterisation Expertise

Our scientists offer BsAb characterisation, with a focus on monitoring relevant CQAs. We can help you to demonstrate consistency or comparability of manufactured batches or as release tests for clinical trial materials, stability studies or on-going GMP batch release tests. Our services include: 

  • Intact molecular weight (MW) and MW distribution (mass spectrometry, SEC-MALS)
  • Amino acid sequence and composition (peptide mapping, mass spectrometry, amino acid analysis)
  • Glycan profiling (HILIC-FLR-MS)
  • Extinction coefficient determination and validation
  • Electrophoretic and isoform patterns (cIEF, gel IEF, SDS PAGE, Western Blot, CZE)
  • Liquid chromatographic patterns (RP-HPLC, Ion Exchange HPLC, SEC)
  • Spectroscopic profile (CD, NMR, FTIR, Fluorescence) for secondary and higher order structure
  • Disulphide bridge mapping (Mass spectrometry)
  • Terminal amino acid sequencing including K clipping, proline amidation, pyroglutamic acid. (mass spectrometry, CE)
  • Evaluation of PTMs including oxidation and deamidation (Mass spectrometry, cIEF)
  • Biologic potency assessment
  • Product related impurity assessment (RP-HPLC, Ion exchange HPLC, Mass spectrometry)
  • Aggregation studies (SEC, DLS, western blot)
  • Forced degradation studies
  • Quantification of host cell proteins (HCP) -total or individual HCPs and residual DNA
  • Physicochemical properties (includes colour, clarity / opalescence, pH, particulates, turbidity, extractable volume, moisture, osmolality)
  • Chain mismatching/fragments/homodimers (liquid chromatography-mass spectrometry, size exclusion chromatography-mass spectrometry, CE)

Total Quality Assurance

At Intertek, we apply our experience, industry and regulatory knowledge to design-phase specific analytical development programs, tailored to your BsAb characterisation needs. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.

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