Sterile affinity chromatography resin
US10071364B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Jan 16, 2015 |
| Grant date | Sep 11, 2018 |
| Priority date | — |
| Expiry date | Jan 16, 2035 |
Classification
- Technology area (CPC Y)Emerging Cross-Sectional Technologies
- CPC primaryY10T29/49826
- WIPO fieldChemical engineering
- WIPO sectorChemistry
Abstract
Provided herein are methods of reducing bioburden of (e.g., sterilizing) a chromatography resin that include exposing a container including a composition including a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one antioxidant agent and/or chelator 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 at least one chelator and/or antioxidant agent, 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.