Depth filters for disposable biotechnological processes

Patent metadata

Field	Value
Publication number	US-11504646-B2
Application number	US-202017008690-A
Country	US
Kind code	B2
Filing date	Sep 1, 2020
Priority date	Jul 8, 2011
Publication date	Nov 22, 2022
Grant date	Nov 22, 2022

Abstract

A process for the primary clarification of feeds, including chemically treated flocculated feeds, containing the target biomolecules of interest such as mAbs, mammalian cell cultures, or bacterial cell cultures, using a primary clarification depth filtration device without the use of a primary clarification centrifugation step or a primary clarification tangential flow microfiltration step. The primary clarification depth filtration device contains a porous depth filter having graded porous layers of varying pore ratings. The primary clarification depth filtration device filters fluid feeds, including chemically treated flocculated feeds containing flocculated cellular debris and colloidal particulates having a particle size distribution of approximately about 0.5 μm to 200 μm, at a flow rate of about 10 litres/m2/hr to about 100 litres/m2/hr. Kits and methods of using and making the same are also provided.

First claim

What is claimed is:

1. A depth filtration device for the primary clarification of a feed containing a target biomolecule of interest and a plurality of cellular debris and/or colloidal particulates without the use of a primary clarification centrifugation step or a primary clarification tangential flow microfiltration step, comprising:
a graded porous depth filter media, comprising an assembly of individually produced layers, wherein each layer in the graded porous depth filter media is in contact with at least one other layer, selected from the group consisting of:
(i) from top to bottom, having 2 non-woven fiber layers each having a nominal pore size of 100 μm, followed by 2 non-woven fiber layers each having a nominal pore size of 50 μm followed by 2 non-woven fiber layers each having a nominal pore size of 25 μm, followed by one layer of cellulose and one layer consisting of diatomaceous earth; and
(ii) from top to bottom, having 2 non-woven fiber layers each having a nominal pore size of 25 μm, followed by 2 non-woven fiber layers each having a nominal pore size of 10 μm, followed by 2 non-woven fiber layers each having a nominal pore size of 5 μm followed by 1 layer of cellulose and 1 layer consisting of diatomaceous earth; and
(iii) from top to bottom, having 2 non-woven fiber layers each having a nominal pore size of 50 μm, followed by 2 non-woven fiber layers each having a nominal pore size of 25 μm, followed by 2 non-woven fiber layers each having a nominal pore size of 10 μm, followed by 1 layer of cellulose and 1 layer consisting of diatomaceous earth; and
(iv) from top to bottom, having 2 non-woven fiber layers each having a pore size of 100 μm, followed by 2 non-woven fiber layers each having a pore size of 50 μm, followed by 2 non-woven fiber layers each having a pore size of 25 μm, followed by one layer consisting of diatomaceous earth and one layer comprising cellulose; and
(v) from top to bottom, having 2 non-woven fiber layers each having a pore size of 35 μm, followed by 2 non-woven fiber layers each having a pore size of 15 μm, followed by 2 non-woven fiber layers each having a pore size of 10 μm, followed by one layer consisting of diatomaceous earth and one layer of cellulose; and
(vi) from top to bottom, having 2 non-woven fiber layers each having a pore size of 30 μm, followed by 2 non-woven fiber layers each having a pore size of 25 μm, followed by 2 non-woven fiber layers each having a pore size of 20 μm, followed by one layer of cellulose and one layer consisting of diatomaceous earth.

2. The depth filtration device of claim 1 wherein the device has a total thickness of about 0.3 cm to about 3 cm.

3. The depth filtration device of claim 1 , wherein the media is anisotropic.

4. The depth filtration device of claim 1 , wherein the media comprises a composite of graded layers of non-woven fibers, diatomaceous earth and, optionally, cellulose and the media having an open nominal pore size rating sufficient to filter a chemically flocculated feedstock.

5. The depth filtration device of claim 1 , wherein the non-woven fibers are selected from a group consisting of one or more of polypropylene, polyethylene, polyester, or nylon.

6. The depth filtration device of claim 1 , wherein the cellular debris and the colloidal particulates have a particle size distribution from about 0.5 μm to about 200 μm, and a mean particle size greater than about 10 μm.

7. The depth filtration device of claim 1 , wherein the media provides throughputs greater than 100 L/M2/hr and removes flocculated cellular debris and colloidal particulates having a particle size distribution of about 0.5 μm to about 200 μm from a feedstream by means of filtration.

8. The depth filtration device of claim 7 , wherein the feed has greater than 3% solids resulting in a turbidity output less than 20 NTU when a chemical flocculant is added to the feed.

9. The depth filtration device of claim 1 , wherein the target biomolecule of interest includes monoclonal antibodies (mAbs), polyclonal antibodies, and biotherapeutics.

10. The depth filtration device of claim 1 ; and, a bioreactor in fluid communication with said depth filtration device.

Assignees

• Emd Millipore Corp

Inventors

• Singh Nripen
• Cheng Kwok-Shun

Classifications

• B01D15/125 Primary

  Pre-filtration · CPC title

• B01D2239/065

  More than one layer present in the filtering material · CPC title

• C12M1/10

  rotatably mounted · CPC title

• C07K1/18

  Ion-exchange chromatography · CPC title

• B01D2239/025

  comprising nanofibres · CPC title