Sterile chromatography resin and use thereof in manufacturing processes
US11369703B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Aug 16, 2019 |
| Grant date | Jun 28, 2022 |
| Priority date | — |
| Expiry date | Dec 17, 2039 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG01N30/50
- WIPO fieldChemical engineering
- WIPO sectorChemistry
Abstract
Provided herein are methods of reducing bioburden of a chromatography resin that include exposing a container including a composition including (i) a chromatography resin and (ii) a liquid including at least on alcohol to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one alcohol are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and a liquid including at least one alcohol, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified recombinant protein.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.