IP Library Granted Patent US 10,716,887
Granted Patent B2
US 10,716,887 · App. 16/024,889 · Granted Jul 21, 2020

Filtration module

Inventor: Jonathan Leland (Gaithersburg, MD)
Assignee: PDL BioPharma, Inc.
A61M1/34A61M1/341B01D61/18B01D63/084G01N33/491A61M2205/75
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Quick Facts
Patent No.
US 10,716,887
App. No.
16/024,889
Granted
Jul 21, 2020
Kind
B2
Abstract

Provided is a filtration module for separating plasma from blood comprising a feeder channel lid, a feeder channel defined by a feeder channel laminating layer having a thickness of less than 5 mil, a filter element in fluid communication with the feeder channel and having a pore size of less than 2 microns and low surface area, and a filtrate take-off port having a dead volume of less than 10 μL. Also provided are methods for filtering a blood sample comprising supplying the blood sample to a feeder channel of a filtration module and drawing the blood sample over a filter element of the filtration module in a single pass process configuration to provide a retentate and a plasma filtrate.

Claims (39)

1. A method for filtering a blood sample, the method comprising:

supplying the blood sample to a feeder channel of a filtration module wherein the filtration module comprises:

a feeder channel lid adjacent to a feeder channel laminating layer having a thickness of less than about 5 mil;

the feeder channel defined by the feeder channel lid and the feeder channel laminating layer;

a filter element having an inlet and a retentate outlet, the filter element adjacent to the feeder channel laminating layer and in fluid communication with the feeder channel, wherein the filter element inlet is adapted to receive the blood sample passing through the filtration module;

the filter element having:

a pore size of less than about 2 microns; and

a ratio of actual surface area to projected surface area of less than or equal to 5.0; and

a filtrate take-off layer adjacent to the filter element and having an inlet port, a retentate outlet port and a filtrate take-off port having a dead volume of less than about 10 μL, wherein the inlet port is adapted to receive the blood sample flowing into the filtration module and the retentate outlet port is adapted to carry a retentate out of the filtration module;

drawing the blood sample over the filter element of the filtration module in a single pass process configuration to provide the retentate and a plasma filtrate; and

discarding the retentate or further processing the plasma filtrate.

2. The method of claim 1 , wherein the filtrate take-off port has a dead volume of less than or equal to 2.5 μL per mL of blood filtered.

3. The method of claim 1 , wherein the filtrate take-off port has a dead volume of less than or equal to 2.9 μL per cm 2 of filtrate take-off port area.

4. A method for filtering a blood sample, the method comprising:

supplying the blood sample to a feeder channel of a filtration module, wherein the filtration module comprises:

a feeder channel lid adjacent to a feeder channel laminating layer having a thickness of less than about 5 mil;

the feeder channel defined by the feeder channel lid and the feeder channel laminating layer;

a filter element having an inlet and a retentate outlet, the filter element adjacent to the feeder channel laminating layer and in fluid communication with the feeder channel, wherein the filter element inlet is adapted to receive the blood sample passing through the filtration module;

the filter element having:

a pore size of less than about 2 microns; and

a filter element exposed area of less than or equal to 0.6 cm 2 per mL of filtered blood; and

a filtrate take-off layer adjacent to the filter element and having an inlet port, a retentate outlet port and a filtrate take-off port having a dead volume of less than about 10 μL, wherein the inlet port is adapted to receive the blood sample flowing into the filtration module and the retentate outlet port is adapted to carry a retentate out of the filtration module;

drawing the blood sample over the filter element of the filtration module in a single pass process configuration to provide the retentate and a plasma filtrate; and

discarding the retentate or further processing the plasma filtrate.

5. The method of claim 4 , wherein the filtrate take-off port has a dead volume of less than or equal to 2.5 μL per mL of blood filtered.

6. The method of claim 4 , wherein the filtrate take-off port has a dead volume of less than or equal to 2.9 μL per cm 2 of filtrate take-off port area.

7. A method for filtering a blood sample, the method comprising:

supplying the blood sample to a feeder channel of a filtration module wherein the filtration module comprises:

a support layer adjacent to a laminating element having one or more secondary channels adapted to fluidically communicate with an inlet port and an outlet port of a feeder channel lid;

the laminating element adjacent to the feeder channel lid;

the feeder channel lid adjacent to a feeder channel laminating layer;

a feeder channel defined by the feeder channel lid and the feeder channel laminating layer having a thickness of less than about 5 mil;

a filter element adjacent to the feeder channel laminating layer and in fluid communication with the feeder channel, the filter element having:

a pore size of less than about 2 microns; and

a ratio of actual surface area to projected surface area of less than or equal to 5.0;

a filtrate take-off layer adjacent to the filter element and having an inlet port, a retentate outlet port and a filtrate take-off port having a dead volume of less than about 10 μL, wherein the inlet port is adapted to receive the sample flowing into the filtration module and the retentate outlet port is adapted to carry a retentate out of the filtration module; and

drawing the blood sample over a filter element of the filtration module in a single pass process configuration to provide a retentate and a plasma filtrate, wherein the method comprises a plasma recovery efficiency of greater than about 15%.

8. The method of claim 7 , wherein the filtrate take-off port has a dead volume of less than or equal to 2.5 μL per mL of blood filtered.

9. The method of claim 7 , wherein the filtrate take-off port has a dead volume of less than or equal to 2.9 μL per cm 2 of filtrate take-off port area.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 29, 2023
From: DEFINED DIAGNOSTICS, LLC
To: PHARMA CINQ, LLC
Reel/Frame 065983/0433 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 16, 2021
From: PDL BIOPHARMA, INC.
To: DEFINED DIAGNOSTICS, LLC (F/K/A WELLSTAT DIAGNOSTICS, LLC)
Reel/Frame 055313/0842 →
Continuity (3)
Division 14361733
Provisional Application 61565253 · Nov 30, 2011
Related Publication 20180369473A1 · Dec 27, 2018