Methods For Increasing The Capacity Of Purification Processes

Patent metadata

Field	Value
Publication number	US-2019153027-A1
Application number	US-201916259489-A
Country	US
Kind code	A1
Filing date	Jan 28, 2019
Priority date	Jun 16, 2014
Publication date	May 23, 2019
Grant date	—

Abstract

In various embodiments, the present invention provides a process for separating target proteins from non-target proteins in a sample comprising increasing the concentration of the target proteins and non-target proteins in the sample and subsequently delivering the concentrated sample to a chromatography device. In other embodiments, the invention relates to a process for increasing the capacity of a chromatography device for a target protein by delivering a concentrated sample comprising the target protein to a chromatography device.

First claim

What is claimed is:

1 . A process for purifying target proteins from non-target proteins and viruses in a liquid sample, comprising:
a) increasing a concentration of target proteins, non-target proteins, and viruses in the sample by a single-pass tangential flow filtration (SPTFF) process to produce a concentrated feed; b) delivering the concentrated feed to an anion exchange (AEX) chromatography device; c) separating the target proteins from the non-target proteins and viruses in the AEX chromatography device; and d) recovering the target proteins from the AEX chromatography device.

2 . The process of claim 1 , further comprising diafiltering the liquid sample prior to increasing the concentration of target proteins and non-target proteins in the sample by the SPTFF process.

3 . The process of claim 2 , wherein diafiltering the liquid sample includes adding a diafiltration solution to the unfiltered sample at a same rate of removing permeate from the sample during the SPTFF process.

4 . The process of claim 1 , wherein the SPTFF process provides direct flow-through concentration of the liquid sample to the AEX device.

5 . The process of claim 1 , wherein the AEX chromatography device includes an Eshmuno® Q resin.

6 . The process of claim 1 , wherein the SPTFF process is an ultrafiltration SPTFF process.

7 . The process of claim 1 , wherein the target proteins are monoclonal antibodies.

8 . The process of claim 1 , wherein the non-target proteins are host cell proteins from hybridoma cells expressing the target protein.

9 . A process for purifying target proteins from non-target proteins in a liquid sample, comprising:
a) increasing a concentration of target proteins and non-target proteins in the sample by a single-pass tangential flow filtration (SPTFF) process to produce a concentrated feed; b) delivering the concentrated feed to protein A chromatography device; c) separating the target proteins from the non-target proteins in the protein A chromatography device; and d) recovering the target proteins from the protein A chromatography device.

10 . The process of claim 9 , wherein the SPTFF process provides direct flow-through concentration of the liquid sample to the protein A chromatography device.

11 . The process of claim 9 , wherein the protein A chromatography device includes a protein A affinity resin.

12 . The process of claim 9 , wherein the protein A chromatography device includes a protein A affinity membrane.

13 . The process of claim 9 , wherein the target proteins are monoclonal antibodies.

14 . The process of claim 9 , wherein the non-target proteins are host cell proteins from hybridoma cells expressing the target protein.

Assignees

• Emd Millipore Corp

Inventors

• Natarajan Venkatesh
• Lutz Herbert
• Raghunath Bala

Classifications

• A61L2103/05

  Living organisms or biological materials · CPC title

• A61L2/022

  Filtration · CPC title

• C07K16/00

  Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies · CPC title

• C07K1/34

  by filtration, ultrafiltration or reverse osmosis · CPC title

• B01D2313/58

  Parts of membrane modules specifically adapted for single use · CPC title