White Paper Download: Characterization of Bispecifics

Current Analytical Approaches to Address CMC Quality Considerations

The activity, efficacy and immunogenicity of bispecific antibodies (bsAbs) are influenced by molecular structure and properties and so understanding and control of these should be demonstrated during development and manufacture. Structural characterization of bsAbs requires multiple analytical approaches to assess all expected properties in line with ICH guidelines.

In this article, Intertek’s experts Michael Walker and Tom Miles describe key considerations for the characterization of an asymmetric heterodimeric bsAb including structural characterization, purity/impurities and potency.

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