Creative Diagnostics, a leading manufacturer and supplier of antibodies, antigens and assay kits, has announced a series of new reagent solutions to assist researchers in the bioanalysis of antibody-drug conjugates (ADCs), including ELISA kits, anti-drug antibodies, anti-MMAE antibodies and paired conjugates.

ADCs are a class of conjugated monoclonal antibodies that covalently bind cytotoxic small-molecule compounds through the conjugation arm, improving the targeting of traditional small-molecule anti-tumor drugs and reducing toxic side effects. The biological analysis of ADCs is challenging due to the structural heterogeneity of ADCs and the dynamic changes of the drug-antibody ratio (DAR) in vivo.

ADCs are emerging as powerful cancer therapies, and investigation of the pharmacokinetics (PK) of ADCs is essential in both preclinical and clinical studies. In particular, differences in the PK profiles of ADCs may exist between animal models and human studies. Therefore, the selection of appropriate antibody reagents is expected to reduce the interference caused by such differences. Commonly used analytes to characterize the PK of ADC drugs include total antibodies, conjugated antibodies, and bound/free small molecule drugs. ELISA is also an important method for ADC PK studies, and anti-loading antibodies are one of the tools.

Creative Diagnostics has developed anti-MMAE antibodies and paired conjugates suitable for the development of ADC ELISA assays. They can be used to quantitatively determine ADC levels in test samples, resulting in significant time and cost savings. Creative Diagnostics also offers a range of monoclonal and polyclonal antibodies against several classes of cytotoxic drugs. These drug-resistant antibodies are valuable tools for PK and safety assessment of newly developed ADCs with these drugs.

In addition, Creative Diagnostics provides a series of ELISA kits for the monitoring of biological drugs. Production is carried out in accordance with the ISO 13485 quality management system and involves expert scientists. After each production run, quality control experiments are performed by experienced scientists according to CLSI and FDA guidelines.

For example, the MMAE ADC EIA Kit (Catalog # DEIABL312) is designed for the quantitative determination of antibody-MMAE conjugate levels in a test specimen. It is suitable for preclinical and clinical pharmacology studies of MMAE ADCs. Moreover, tissue/cell culture and serum samples from human, rats, mice, primates, etc. can be used directly with this kit. Both humanized monoclonal antibody-based MMAE-ADC and mouse monoclonal antibody-based MMAE-ADC can also be measured with this kit.

Another example is the Intact MMAF ADC ELISA Kit (Catalog # DEIABL315). This highly sensitive "sandwich" assay kit is designed to quantify antibody-MMAF conjugate levels in human, mouse, rat, and non-human primate serum or plasma within 2 hours. It is also useful for preclinical and clinical pharmacology studies of MMAF ADCs.

For more information on Creative Diagnostics' reagent solutions for the bioanalysis of ADCs, please visit https://www.creative-diagnostics.com/bioanalysis-of-antibody-drug-conjugates.htm.

About Creative Diagnostics

Creative Diagnostics is a leading manufacturer and supplier of antibodies, viral antigens, innovative diagnostic components, and critical assay reagents. In addition to providing contract RD and biologic manufacturing services for diagnostic manufacturers along with GMP biologics manufacturing for the biopharmaceutical market, the company aims to continue to act as a trusted source for all researchers’ assay development and manufacturing needs.