Potency assays for antibody drug substance binding to an Fc receptor
US9580506B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Jul 21, 2006 |
| Grant date | Feb 28, 2017 |
| Priority date | — |
| Expiry date | Aug 29, 2029 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG01N2333/70535
- WIPO fieldMeasurement
- WIPO sectorInstruments
Abstract
The invention relates to a method of characterizing an antibody, which method is suitable as a potency assay for batch release of a pharmaceutical composition comprising an antibody, specifically for use when applying for marketing authorization for said pharmaceutical composition. The assay provided is a method for determining the potency of a drug product comprising an FcR binding peptide, wherein at least one mechanism of action of the FcR binding peptide of the drug product is mediated through the binding of the FcR binding peptide of the drug product to a Fc receptor, wherein said method comprises determining the binding of the FcR binding peptide of the drug product to an Fc receptor.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.