The new findings released by Bio-Rad detail the generation and characterisation of Drug-Target Complex-Specific Type 3 Antibodies for pharmacokinetic (PK) analysis of biotherapeutics. By describing the Type 3 antibodies the team demonstrated the advantages of these antibodies for drug quantification over other types. The company, headquartered in California, develop, manufacture, and market a range of products for the life science research and clinical diagnostic markets.
PK assays are used to provide evidence for the approval of an original biologic or biosimilar drug, and anti-idiotypic antibodies are critical reagents used in these types of ligand binding assays (LBAs).
Bio-Rad’s team demonstrated the increased sensitivity and specificity across several LBA formats, with the Type 3 antibodies. They also quantified monovalent antibody fragments such as ranibizumab, which is difficult to achieve with commonly used LBAs like bridging assays.
Stefan Harth, the R&D team leader and lead author of the paper, said: “Drug development relies on ligand binding assays, and the robustness, accuracy and reproducibility of these assays depends on the quality of critical reagents used.”
Harth continued: the findings are “important in characterising drug-target complex-specific reagents as useful tools in those assays, demonstrating several advantageous properties, to ultimately improve the accuracy of conclusions and accelerate the drug development process.”
In addition, the team introduce a derivative of Type 3, Type 4. Type 4 provides an alternative when the drug target is not easily available or costly to produce, or when the selection of Type 3 is not possible.