Anti-idiotypic Antibody Production for PK Assay

Therapeutic antibodies are the fastest growing class of drugs in the treatment of cancer, inflammatory diseases, and autoimmune disorders. Sensitive pharmacokinetic (PK) assays and immunogenicity assessment are required in the development process for biotherapeutic proteins. Ligand binding assays (LBAs) are often used to determine the PK profile by quantitating the therapeutic protein in biological matrices such as serum. However, high specificity and binding activity are necessary for the application of LBAs. Therefore, anti-idiotypic antibodies targeting the idiotypic determinants of individual antibody drugs are recognized as perfect reagents for such LBAs. Based on our skilled groups and mature technologies, Creative Biolabs has launched a series of anti-idiotypic antibody products as well as customized one-stop services. After more than a decade's labor, we have established advanced immune antibody library construction and screening methods platforms to meet our customers' needs.

Introduction of Anti-idiotypic Antibody and PK Assay

Due to the total humanization of developed therapeutic antibodies, the drug becomes hidden within the high concentration of very similar antibodies in human serum, which brings difficulties to detect and quantify. In order to measure drug levels with a PK assay, anti-idiotypic antibodies with high specificity only bind to the antibody drugs but not to the vast excess of similar Ig molecules is necessary.

Fig.1 Antibody idiotope.¹

The structure in the variable regions of an Ig, specifically the complementarity determining regions (CDRs) that confer its antigenic specificity, is known as the idiotype. It is obvious that the idiotopes are unique for each antibody which determines the binding capacity of different anti-idiotypic antibodies.

Application of Anti-idiotypic Antibody in PK Assay

Anti-idiotype antibodies represent a class of reagents that are potentially optimal for analyzing the PK of fully human antibodies that have been developed as therapeutic candidates. Indeed, anti-idiotype antibodies are usually combined with ELISA to detect the concentration of target antibodies. Compared with drug target capture, anti-idiotypic antibody bridging reduced the false positive rate significantly due to the high specificity of reagents.

Fig.2 Drug target capture and detection with anti-idiotypic antibodies.²

Up to now, we have developed three mature approaches in developing anti-idiotypic antibodies: immunized phage display library technology, premade non-immunized human phage display library technology, and hybridomas technology, both of which can be applied to discover available anti-idiotypic antibodies for PK Assay.

Advantage of Our Anti-idiotypic Antibodies

Fast, low-cost, and widely used
Sensitive and reproducible
High binding affinity

Anti-idiotypic antibody based PK assay is widely used in pre-clinical research. Creative Biolabs provides customized one-stop services for anti-idiotypic antibody production. For more details please feel free to contact us.

Reference

López-Requena, Alejandro, Oscar R. Burrone, and Michela Cesco-Gaspere. "Idiotypes as immunogens: facing the challenge of inducing strong therapeutic immune responses against the variable region of immunoglobulins." Frontiers in oncology 2 (2012): 159.
Qin, Qiuping, and Likun Gong. "Current Analytical Strategies for Antibody–Drug Conjugates in Biomatrices." Molecules 27.19 (2022): 6299.

All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.

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