Invention Grant
- Patent Title: Methods for continuously inactivating a virus during manufacture of a protein
-
Application No.: US16083650Application Date: 2017-03-10
-
Publication No.: US11407981B2Publication Date: 2022-08-09
- Inventor: Marcus Andre Fiadeiro , Jonathan Coffman , Robert Lee Fahrner , Jill Ann Kublbeck , Raquel Orozco , Jeffrey Richard Salm
- Applicant: Boehringer Ingelheim International GmbH
- Applicant Address: DE Ingelheim am Rhein
- Assignee: Boehringer Ingelheim International GmbH
- Current Assignee: Boehringer Ingelheim International GmbH
- Current Assignee Address: DE Ingelheim am Rhein
- Agent Shelley A. Jones
- International Application: PCT/US2017/021714 WO 20170310
- International Announcement: WO2017/156355 WO 20170914
- Main IPC: C12N7/00
- IPC: C12N7/00 ; C07K16/00

Abstract:
Methods for continuously inactivating a virus during manufacture of a protein are provided. Steps include (1) combining, at a single predetermined volumetric ratio, a composition including the protein, and a composition including a virus-inactivation reagent, to obtain a treatment composition having a predetermined property for inactivation of a virus; (2) transferring the treatment composition to a treatment vessel; (3) incubating the treatment composition in the treatment vessel at predetermined conditions; and (4) subjecting the treatment composition to a post-treatment processing operation. The single predetermined volumetric ratio has been selected to ensure that the predetermined property of the treatment composition is maintained across a range of concentrations predicted for the protein in the composition including the protein. Steps (1) to (3) are carried out (a) continuously and (b) without feedback control being exerted by either adjustment of the volumetric ratio or diversion of the treatment composition.
Public/Granted literature
- US20190071647A1 METHODS FOR CONTINUOUSLY INACTIVATING A VIRUS DURING MANUFACTURE OF A PROTEIN Public/Granted day:2019-03-07
Information query