Device and method for continuous virus inactivation

Patent metadata

Field	Value
Publication number	US-10022463-B2
Application number	US-201515125130-A
Country	US
Kind code	B2
Filing date	Mar 6, 2015
Priority date	Mar 11, 2014
Publication date	Jul 17, 2018
Grant date	Jul 17, 2018

Abstract

The invention provides an apparatus and a process for continuous virus inactivation. The apparatus for continuous virus inactivation in a product stream comprises a tube or hose 1 having an inlet 4 and an outlet 5 in each case connected to a product flow line 8 for conveying the product stream, where the tube or the hose 1 is curved and/or helically coiled with a number n of windings around a coil axis h and has one or more changes in direction and/or bends 2 in the coil axis h having an angle α of from 45° to 180° to alter the direction of action of the normals of the centrifugal force and the apparatus is characterized by a Dean number>0 and a torsion parameter>0.

First claim

The invention claimed is:

1. A process for continuous virus inactivation of a product stream using an apparatus, which comprises the following steps:
a) provision of the product stream to be inactivated,
b) introduction of the product stream into an inlet ( 4 ) of a tube or hose ( 1 ) having the inlet ( 4 ) and an outlet ( 5 ), where the tube or hose ( 1 ) is curved and/or helically coiled with a number n of windings around a coil axis h and has one or more changes in direction and/or bends ( 2 ) in the coil axis having an angle α of from 45° to 180° to alter the direction of action of normals of a centrifugal force, where the apparatus is characterized by a Dean number >2 and a torsion parameter >100,
c) flow of the product stream through the tube or hose ( 1 ) under virus-inactivating conditions, and
d) exit from the tube or hose ( 1 ) through the outlet ( 5 ),
wherein the pH of the product stream in step a) is set to a value of ≤4 and wherein the pH is set to ≥5 after step d) in order to stop virus inactivation.

2. The process according to claim 1 , characterized in that the apparatus in step b) is characterized by a Dean number ≥3, and a torsion parameter ≥300.

3. The process according to claim 1 , characterized in that the product stream comprises a solution of macromolecules, preferably a protein or peptide solution, particularly preferably an antibody solution.

Assignees

• Bayer Ag

Inventors

• Lobedann Martin
• Klutz Stephan
• Kurt Safa Kutup

Classifications

• A61L2/18 Primary

  Liquid substances · CPC title

• A61L2202/15

  Biocide distribution means, e.g. nozzles, pumps, manifolds, fans, baffles, sprayers · CPC title

• A61L2/10 Primary

  Ultraviolet [UV] radiation · CPC title

• A61L2202/21

  Human Necessities · mapped topic

• A61L2/0088 Primary

  Human Necessities · mapped topic