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Publication Number
US-11578098-B2
Publication Date
2023-02-14
Expiration Date
Abstract
The present invention is directed to a method of inactivating virus that is present during production of a polypeptide of interest. In particular, the present invention is directed to a method of on-column virus inactivation using a low pH and high salt wash solution that effectively inactivates viruses with minimum recovery loss of the polypeptide.
Core Innovation
The method produces a purified polypeptide of interest through recombinant production in human cell culture and on-column viral inactivation. A polypeptide of interest binds to a chromatography matrix and undergoes salt-containing washes, including a low-pH treatment configured to substantially reduce product elution. These operational wash conditions and sequences are [procedural detail omitted for safety].
The described approach directly addresses product loss and exposure to low pH during viral inactivation in polypeptide purification processes. It provides viral clearance and product recovery while retaining antibodies on chromatography resins under low-pH viral-inactivation conditions. In addition, the method avoids conductivity addition during pool acidification, automates inactivation, and supports semi-continuous multi-column chromatography systems.
Claims Coverage
The claims include two independent claims covering two inventive features concerning the production of a purified polypeptide in human cell culture using salt-containing chromatography washes.
Salt-containing low-pH wash
The claim covers recombinant production of a polypeptide of interest in human cell culture, binding the polypeptide to a chromatography matrix, washing the bound polypeptide at a higher pH, and applying a low-pH wash solution containing sufficient salt to substantially reduce elution of the polypeptide, wherein operational conditions are [procedural detail omitted for safety].
Sequential salt washes around a low-pH wash
The claim covers recombinant production of a polypeptide of interest in human cell culture, binding the polypeptide to a chromatography matrix, and washing the matrix sequentially with a higher-pH salt solution, a low-pH salt solution, and a further higher-pH salt solution, wherein operational conditions are [procedural detail omitted for safety].
The two independent claims cover salt-based chromatography washing methods for polypeptide purification, comprising a low-pH wash configured to substantially reduce polypeptide elution and a sequential salt-wash arrangement.
Stated Advantages
Reduces low-pH exposure and product loss during viral inactivation.
Provides viral clearance with substantial product recovery while reducing polypeptide elution.
Avoids conductivity addition during pool acidification.
Automates and simplifies viral inactivation in semi-continuous multi-column chromatography systems.
Documented Applications
On-column low-pH viral inactivation during polypeptide purification using chromatography, including Protein A and mixed-mode chromatography.
Purification of FIX-Fc and monoclonal antibodies.
Semi-continuous multi-column chromatography.
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