Sterile chromatography and manufacturing processes
US10087214B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Jan 16, 2015 |
| Grant date | Oct 2, 2018 |
| Priority date | — |
| Expiry date | Nov 24, 2036 |
Classification
- Technology area (CPC C)Chemistry; Metallurgy
- CPC primaryC12Y302/01022
- WIPO fieldChemical engineering
- WIPO sectorChemistry
Abstract
Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.