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European Biopharmaceutical Review

ADC Characterisation

The biopharmaceutical industry is experiencing unprecedented growth that is primarily driven by the development and implementation of monoclonal antibody (mAb)-based therapeutics. mAbs have been shown as promising therapeutics for the treatment of a variety of lifethreatening diseases, particularly cancer (1). More than 40 therapeutic mAbs have been approved for treatment, and hundreds more are currently under development. One class of therapeutic mAbs that serve as potential chemotherapeutic agents is antibody-drug conjugates (ADCs). Several ADCs have received market approval, mainly for oncology treatment. The potential of ADCs is due to the ability of the antibody to target specific cells, which leads to lower toxicity of the drug and therefore increases drug dosage levels that are safer than chemotherapeutic agents. The development of ADCs is challenging. In this article, the analytical techniques currently used to determine the drug-to-antibody ratios (DARs), their limitations, and potential novel combinations of characterisation techniques are explored.

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Christopher M Bianchetti PhD is a Research Scientist in the method development and validation group at PPD® Laboratories, where he is responsible for providing technical guidance on scientific method development and validation projects and troubleshooting instruments, methods, and procedures. Christopher has more than 12 years of experience in protein production, purification, and the biochemical and biophysical characterisation of macromolecules (proteins, nucleic acids, and polysaccharides). Previously, he led an independent research group that designed and implemented high-throughput biochemical methods to screen enzymes for novel carbohydrate degrading activity.

Henry J Parker is an Associate Scientist in the biopharma method development and validation group at PPD Laboratories, where he is responsible for designing, developing, and validating scientific methods for the analysis of biopharmaceutical products. Henry has more than three years’ experience in the biochemical and biophysical characterisation of macromolecules using techniques such as high-performance liquid chromatography and capillary electrophoresis.

Katherine C Hanson PhD is the Lab Manager for the biopharma method development and validation group at PPD Laboratories. Katherine has more than five years of experience in development and validation of GMP-compliant analytical methods for a wide range of compounds, including enzymes, antibodies, and viral gene therapies. Previously, she was a Protein Engineer focused on determining mechanism of action for molecular motors.

Stephen Gacheru PhD serves as the Vice President of biopharmaceutical product development for PPD Laboratories, where he oversees analytical testing for large molecules. Stephen has more than 20 years’ experience working in the biologics field. He has extensive global experience in protein characterisation, validations, and regulatory submissions. He also has expertise in outsourcing to CMOs and CROs, working with clients and developing successful customer supply relationships.
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Christopher M Bianchetti PhD
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Henry J Parker
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Katherine C Hanson PhD
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Stephen Gacheru PhD
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