Viral clearance evaluation for biological medical product preparation processes
US12203914B2 · kind B2 · utility
Assignee
Inventor
Key dates
| Filing date | Nov 12, 2020 |
| Grant date | Jan 21, 2025 |
| Priority date | — |
| Expiry date | Oct 28, 2042 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG01N2496/00
- WIPO fieldMeasurement
- WIPO sectorInstruments
Abstract
Fluorescent viral particles, including viral particles and a fluorescent dye conjugated to the viral particles, are used for viral contaminant removal testing as part of viral clearance evaluation for biological medical product preparation processes. The conjugated fluorescent dye adds only marginally to viral particle size, but provides versatility both for rapid screening of alternative viral removal approaches during process development and for final process validation, as the fluorescent viral particles have fluorescent activity throughout the viral clearance evaluation process, permitting rapid and consistent quantification of initial test solutions, resulting purified solutions, and intermediate solutions of interest at any point during processing under evaluation.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.