Design and Evaluation of a Multiplexed Assay to Assess Human Immunogenicity Against Humira®

Presented By: Paul Rhyne, PhD
Speaker Biography: Dr. Paul Rhyne is a bioassay leader at the Gates Medical Research Institute where he is responsible for the development and validation of bioassays used to support multiple vaccine and therapeutic clinical studies conducted by the Gates Medical Research Institute since 2020. Paul has more than 25 years of scientific leadership in the design and use of bioassays for measuring clinical biomarkers, biologics, anti-drug induced immunogenicity, and vaccine-induced immunogenicity. He is a well-recognized industry expert with experience in multiple pharmaceutical, biotechnology, and contract research organizations. Paul is an active contributor to the scientific community with many peer-reviewed publications and key industry white papers, and is an active member of numerous scientific organizations.
Webinar: Design and Evaluation of a Multiplexed Assay to Assess Human Immunogenicity Against Humira®
Webinar Abstract: The use of biologic-based therapeutics has revolutionized our ability to treat complex diseases such as cancer- and autoimmune-related disorders. Biologic-based therapeutics are known to generate anti-drug immune responses or immunogenicity in clinical patients which can lead to altered pharmacokinetics, decreased drug efficacy, and unwanted adverse clinical events. Assays designed to detect and assess anti-drug immune responses are used to help monitor patients and improve drug safety. Utilizing a tiered approach, screening assays are developed first to identify patients that are potentially positive for anti-drug-specific antibodies. Patients that screen positive are subjected to additional tiers of testing that include a confirmation assay to confirm the presence of expected anti-drugspecific antibodies, a titer assay to assess relative levels of anti-drug-specific antibodies, and, depending on the drug’s mechanism of action or concerns of adverse clinical reactions, further characterization such as drug neutralization and anti-drug antibody isotyping. This tiered approach can prove to be detrimental to clinical samples from exposure to multiple cycles of testing, freeze thaws, and repeated handling by lab personnel. Multiplexing some of these assays together may streamline the characterization of anti-drug immune responses and help reduce the repeated usage of clinical samples. In this study, we combined a screening assay and anti-drug isotyping assays into one multiplexed assay using the Luminex® xMAP® Technology. The multiplexed assay was developed and validated to meet the FDA recommended guidelines for immunogenicity assessments. These results show that multiplexed assays perform comparably to industry standards. This study should encourage labs to explore the use of multiplexing immunogenicity assays to characterize anti-drug antibody responses quickly, with less repeat testing and reduced sample handling.
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