End-to-end continuous purification system
AssigneePAK Biosolutions Inc.
InventorsJoanna Pezzini, Kevin Hill-Byrne
Life of this patent
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Abstract
An automated end-to-end continuous purification system for the manufacture of therapeutic proteins to reduce complexity of manual process operations and minimize physical space requirements, such system comprising a housing containing a control system, a tray and a collection vessel, wherein the system comprises a series of four purification stages, each such stage comprising a product pump and protein product line, a buffer pump and buffer line, a flow kit, two to four pinch valves and a waste line, and all such purification stages are connected by a single protein product line and are operated simultaneously.
Claims18
A protein purification system comprising:
- (A) a housing containing a control system running a first control loop regulating a mass flow through a series of two to four purification stages,
- (B) a collection vessel, and
- (C) the two to four purification stages connected by a protein product line and operated in series simultaneously,
- wherein each purification stage comprises
- (1) a product pump and protein product line,
- (2) a buffer pump and a buffer line,
- (3) a flow kit,
- (4) an apparatus configured to perform a protein purification method selected from the group consisting of:
- virus inactivation, flow through filtration, flow through chromatography, dual column chromatography, inline concentration, and diafiltration,
- (5) two or more valves,
- (6) a sensor configured to measure flow, and
- (7) a waste line;
- wherein a flow rate of each purification stage is controlled by a second control loop comprising a proportional-integral-derivative (PID) controller in communication with the product pump, the buffer pump, and the sensor,
- wherein the second control loop adjusts flow rates of the product and buffer pumps to match the mass flow set by the first control loop;
- wherein the mass flow set by the first control loop is adjusted based on an error in the flow rate of a most critical unit operation,
- wherein criticality in descending order is as follows:
- (a) the virus inactivation, (b) the dual column chromatography, and lastly (c) the flow through filtration or the flow through chromatography;
- whereby the system is capable of continuous protein purification.
Dependencies are inferred from the claim text.