Patent · US Active

Sterile chromatography and manufacturing processes

US11912739B2 · kind B2 · utility

1Cited by
45References
20Claims
0Family size

Assignee

Inventors

Key dates

Filing dateAug 14, 2020
Grant dateFeb 27, 2024
Priority date
Expiry dateNov 11, 2042

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.