Bio-Rad Laboratories, Inc has published new findings on the generation and characterisation of drug-target-complex-specific antibodies for pharmacokinetic (PK) analysis of biotherapeutics. The paper, published in the journal mAbs, discusses antibodies that recognise the drug only when bound to its target. Called Type 3 antibodies, they differ from other anti-idiotypic antibodies that specifically detect free antibody drug by binding the paratope of the drug (Type 1 antibodies) or total drug by binding outside the paratope of the drug (Type 2 antibodies). PK assays form part of the totality of evidence required for approval of an original biologic or biosimilar drug, and anti-idiotypic antibodies are critical reagents used in these types of ligand-binding assays (LBAs). By describing the generation and characterisation of Type 3 specificities for the development of LBAs, the authors demonstrate the advantages of these antibodies as tools for drug quantification.
The paper describes the successful generation of Type 3 antibodies directed against several approved antibody drugs using Bio-Rad’s innovative custom antibody generation service, based on the Human Combinatorial Antibody Library (HuCAL) technology and on Cys-Display, a modified phage display method. This recombinant production ensures a consistent and secure batch-to-batch supply, which is important for assay reproducibility.
Using Type 3 antibodies, Bio-Rad demonstrated increased sensitivity and specificity across several assay formats, and quantified monovalent antibody fragments such as ranibizumab, which is difficult to achieve with commonly-used LBAs such as bridging assays. Additionally, the researchers introduced a derivative of the Type 3 specificity, termed Type 4, providing an alternative when the drug target is not easily available or when it is costly to produce, or when selection of Type 3 is not possible.
For further information about the technology and about Bio-Rad Laboratories visit www.bio-rad.com
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