Immunogenicity testing is focused on the detection and characterization of anti-drug antibodies (ADAs) and the determination whether these ADAs are neutralizing antibodies(NABs), as NABs may affect the pharmacokinetics (PK) of the drug. It is clear however that animal studies are not considered relevant to predict immunogenicity in humans. Still, the selection of the mini-pig to explore their possibilities for immunogenicity testing of biopharmaceuticals, especially to assist in the interpretation of safety studies, is based on the improved knowledge that various physiological aspects of Göttingen Minipigs® resemble more the human situation than other animal species. It is expected therefore that in the near future the safety testing, including immunogenicity testing of biopharmaceuticals in mini-pigs will increase as an alternative for non human primate studies, which use will be limited or restricted.
- Screening assays for detection of positive samples for Anti-Drug Antibodies (ADA)
- Confirmatory assays for ruling out false positive results
- Characterization assays to determine the avidity and the isotypes of ADA
- Neutralizing assays to assess the drug function inhibition capabilities of ADA
- Cellular immune response assays to study the cellular immunogenicity
- Electrochemiluminiscence (ECLA / Meso Scale Discovery)
- Radioimmunoassay (RIA)
- Enzyme-linked immunosorbent assay (ELISA)
> Cell-based Assays:
• Fluorescence and luminescence
> Label-free Interaction Analysis
• Surface plasmon resonance (SPR / Biacore)
Challenges in Immunogenicity Assay
– Many of the therapeutic drugs, particularly an antibody therapeutic, have a long half-life (typically 10-20 days) and often administered chronically at high dose levels without a drug wash-out period.
– Immunogenicity assessments to such therapeutics pose unique challenges in clinical trials especially when significant drug interference is encountered.
– Free drug can complex with anti-drug antibodies directly interferes with the assay.
– Tolerance of the ADA assay for presence of drug to be determined.
– Target interference is also a big concern in bridging immunoassays, especially when target is a soluble receptor.
– Target interference can also be intensified by AD which then release target from target-drug complex.
Our team developed custom bridging assays for new materials that were introduced into the manufacturing processes, to determine their individual immunogenicity profiles. We also re-validated the prior assays with a new positive control that was comparable to the altered biotherapeutic. We then compared the results from these newly validated assays to those from the previous assays to measure any changes in the immunogenicity risk profile of the therapeutic.
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