Unit for Treatment of a Bioprocess Liquid

Patent metadata

Field	Value
Publication number	US-2021017482-A1
Application number	US-201615781217-A
Country	US
Kind code	A1
Filing date	Nov 25, 2016
Priority date	Dec 7, 2015
Publication date	Jan 21, 2021
Grant date	—

Abstract

The invention discloses a first unit (1) for treatment of a bioprocess liquid comprising a first lateral face (2), a second lateral face (3) and a front face (4) which meets the two said lateral faces. The front face comprises: a plurality of valves (7) adapted to receive and act upon one or more legs (8) of a disposable flow path (6); optionally one or more pumps (10) adapted to receive and act upon one or more legs of the disposable flow path; optionally one or more sensors (11) adapted to receive and to measure one or more parameters in one or more legs of the disposable flow path; wherein the plurality of valves and optional pumps and sensors are vertically offset from each other to give one or more legs of a disposable flow path received by said valves and optional pumps and sensors a slope of at least 3.0 degrees from the horizontal plane (h).

First claim

1 . A first unit for treatment of a bioprocess liquid comprising a first lateral face, a second lateral face and a front face which meets the two said lateral faces; said front face comprising:
a plurality of valves adapted to receive and act upon one or more legs of a disposable flow path; optionally one or more pumps adapted to receive and act upon one or more legs of said disposable flow path; optionally one or more sensors adapted to receive and to measure one or more parameters in one or more legs of said disposable flow path; wherein said plurality of valves and optional pumps and sensors are vertically offset from each other to give one or more legs of a disposable flow path received by said valves and optional pumps and sensors a slope of at least 3.0 degrees from the horizontal plane.

2 . The first unit of claim 1 , wherein said valves and optional pumps and sensors are arranged to give one or more legs of said disposable flow path a slope of 3.0-10.0, such as 3.0-8.0 degrees from the horizontal plane.

3 . The first unit of claim 1 , wherein said valves and optional pumps and sensors are arranged to give all legs of said disposable flow path a slope of at least 3.0, such as at least 4.0, degrees from the horizontal plane.

4 . The first unit of claim 1 , further adapted to receive a filter element fluidically connected to said disposable flow path.

5 . The first unit of claim 1 , wherein said plurality of valves comprises one or more pinch valves.

6 . The first unit of claim 1 , wherein said one or more pumps comprise a peristaltic pump.

7 . The first unit of claim 1 , further comprising guides on said front face between said valves and optional pumps and sensors for installation of said disposable flow path, wherein said guides are essentially linear with slopes of at least 3, such as at least 4, degrees from the horizontal plane.

8 . The first unit of claim 7 , wherein said guides comprise visually and/or tactilely distinguishable lines.

9 . The first unit of claim 7 , wherein said guides comprise pegs, ledges and/or recesses adapted to receive said disposable flow path.

10 . The first unit of claim 1 , further comprising a processor with an optical display, wherein a graphical user interface on said optical display shows an outline of said front face with valves, optional pumps and sensors and the flow path, with one or more, such as all, legs of said flow path having a slope of at least 3 degrees from the horizontal plane.

11 . The first unit of claim 1 , which is a tangential flow filtration unit.

12 . The first unit of claim 1 , which is a chromatography unit.

13 . The first unit of claim 1 , which is a bioreactor.

14 . The first unit of claim 1 , adapted to be juxtaposed by the first lateral face against a second unit.

15 . The first unit of claim 14 , adapted to be juxtaposed by the second lateral face against a third unit.

16 . The first unit of claim 14 , wherein at least one of said second and third units is adapted to receive a tank, such as a flexible bag, fluidically connected to said disposable flow path.

17 . The first unit of claim 1 , further comprising a disposable flow path received by said plurality of valves and optional pumps and sensors.

18 . The first unit of claim 17 , wherein the legs of said flow path are aligned with said guides.

19 . The first unit of claim 17 , wherein said disposable flow path comprises at least one air outlet leg and/or at least one draining leg.

20 . An apparatus for treatment of a bioprocess liquid, comprising the first unit of claim 1 and at least one of a second and a third unit juxtaposed by the first and/or second lateral faces.

21 . The apparatus of claim 20 , further comprising one or more of a filtration element, a feed/retentate tank or bag and a permeate tank or bag.

22 . The apparatus of claim 20 , further comprising a disposable flow path with one or more legs having a slope of 3-10, such as 3-8 degrees from the horizontal plane.

23 . The apparatus of claim 22 , wherein said disposable flow path provides fluidical connection between a filtration element and at least one of a feed/retentate tank or bag and a permeate tank or bag.

24 . A method of installing a disposable flow path on the first unit of claim 1 , comprising receiving said disposable flow path in said valves and optional pumps and sensors, wherein one or more, such as all, legs of said disposable flow path have a slope of at least 3, such as at least 4 degrees from the horizontal plane.

25 . The method of claim 24 , wherein said disposable flow path comprises at least one air outlet leg and/or at least one draining leg.

26 . The method of claim 24 , wherein the legs of said flow path are aligned with said guides.

27 . The method of claim 24 , wherein said disposable flow path is presterilized.

28 . A method of tangential flow filtration of a bioprocess liquid comprising the steps of:
a) providing the apparatus of claim 23 ; b) circulating said liquid from said feed/retentate tank or bag through a retentate loop of said disposable flow path and said filtration element and back to said feed/retentate tank or bag; c) conveying a permeate from said filtration element through a permeate line or permeate loop of said disposable flow path either to said permeate tank or bag or to a drain.

29 . The method of claim 28 , comprising, before or during step b), a step a′) of letting out residual air through an air outlet leg of said disposable flow path.

30 . The method of claim 28 , comprising, after step c), a step d) of draining said disposable flow path.

31 . The method of claim 30 , comprising, after step d), a step e) of discarding said disposable flow path.

Assignees

• Ge Healthcare Bio Sciences Ab

Inventors

• Singh Amit Kumar
• Gebauer Klaus
• Datta Supti
• Liderfelt Jakob
• Karmarkar Nachiket
• Vernekar Ajit S
• Olsson Mats
• Rajan Thiyaga
• Sharma Amit K
• Nutalapati Sasi Kumar
• Lundstrom Fredrik
• Neff Jean Pierre

Classifications

• C12M23/28 Primary

  disposable or single use · CPC title

• B01D61/18 Primary

  Apparatus therefor · CPC title

• C12M29/04

  Filters; Permeable or porous membranes or plates, e.g. dialysis · CPC title

• C12M41/00

  Means for regulation, monitoring, measurement or control, e.g. flow regulation (controlling or regulating chemical, physical or physicochemical processes B01J19/0006; heating or cooling apparatus for laboratory use B01L7/00; electro optical investigation of individual particles, flow cytometers G01N15/14; automatic analysis G01N35/00; controlling or regulating in general G06N) · CPC title

• C12M23/50

  Means for positioning or orientating the apparatus (C12M41/08 takes precedence) · CPC title