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High ionic strength dissociation assay (HISDA) for high drug tolerant immunogenicity testing
Gregor Jordan1, Alexander Pöhler1, Florence Guilhot2
1Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Bioanalytical R&D, Roche Innovation Center Munich, Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany.
Bioanalysis
|July 1, 2020
Summary
Magnesium chloride (MgCl2) improves antidrug antibody (ADA) assay drug tolerance. This method offers a sensitive and easy alternative for assessing antibodies in complex biotherapeutic studies.
Area of Science:
- Immunology
- Biochemistry
- Analytical Chemistry
Background:
- Assessing antidrug antibodies (ADAs) can be challenging with high-dose or long half-life biotherapeutics.
- Optimized drug tolerance in ADA assays is crucial for accurate assessment in such cases.
Purpose of the Study:
- To evaluate the efficacy of magnesium chloride (MgCl2) in developing high ionic strength dissociation assays for enhanced ADA assay drug tolerance.
- To maintain the structural integrity of ADAs during the assay process.
Main Methods:
- Investigated the use of MgCl2 in two bridging enzyme-linked immunosorbent ADA assays.
- Compared MgCl2 treatment with overnight incubation and acid dissociation methods.
Main Results:
- MgCl2-treated ADA-bridging assays demonstrated improved drug tolerance.
- Higher signal-to-blank values were observed in MgCl2-treated assays compared to controls.
- The structural integrity of ADAs was maintained.
Conclusions:
- MgCl2 treatment offers a sensitive and user-friendly approach for ADA-bridging assays.
- This method enhances drug tolerance, providing a viable alternative when acid dissociation is unsuitable.
