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A Binding Potency Assay for Pritumumab and Ecto-Domain Vimentin
Ivan Babic1, Santosh Kesari1, Mark C Glassy2,3,4
1Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, Santa Monica, CA, USA.
Methods in Molecular Biology (Clifton, N.J.)
|December 13, 2018
Summary
Pritumumab, a cervical cancer antibody, targets vimentin. Researchers developed a binding assay using ELISA to ensure antibody potency for clinical trials.
Area of Science:
- Immunology
- Oncology
- Biochemistry
Background:
- Pritumumab is a human IgG1kappa monoclonal antibody derived from a cervical cancer patient.
- It targets the cytoskeletal protein vimentin and its cell surface form, ecto-domain vimentin (EDV).
Purpose of the Study:
- To develop and validate a potency binding assay for pritumumab.
- This assay is crucial for ensuring antibody quality before clinical trials.
Main Methods:
- An enzyme-linked immunosorbent assay (ELISA) was developed to measure antibody-antigen binding.
- The assay requires rigorous controls and suitability testing for reagents and components.
Main Results:
- The developed ELISA serves as a reliable method for detecting pritumumab's antigen-binding capacity.
- This assay is suitable for the release of manufactured pritumumab batches for clinical studies.
Conclusions:
- The established ELISA is a critical prerequisite for the clinical development of pritumumab.
- Further validation is needed for its use in stability testing and batch release.
Keywords:
Ecto-domain vimentinEnzyme linked immunosorbent assay (ELISA)Good laboratory practices (GLP)Investigational new drug (IND)Potency assayPritumumabMore Related Videos
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