Novel bioanalytical method for the characterization of the immune response directed against a bispecific F(ab) fragment.

Bioanalysis

Roche Pharma Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Im Nonnenwald 2, 82377 Penzberg, Germany.

Published: April 2020

The work was aimed at developing a bioanalytical approach to identify immunogenic parts of a bispecific F(ab) fragment and to characterize the immune response seen in a preclinical study. The bioanalytical method consists of a set of domain detection assays that use germlined variants of the drug. The method demonstrated that anti-drug antibodies (ADAs) were predominantly directed against both antigen-binding sites of the drug. The method was capable to discriminate between ADAs directed against one of the antigen-binding sites, both sites or the constant domain, allowing for an estimation of the relative binding prevalence for these subunits. The developed approach provides a practical and robust solution for exploratory characterization of ADAs against multidomain biotherapeutics.

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http://dx.doi.org/10.4155/bio-2020-0064DOI Listing

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