US 12,458,908 B2
End-to-end continuous purification system
Joanna Pezzini, Burke, VA (US); and Kevin Hill-Byrne, Rockville, MD (US)
Assigned to PAK BioSolutions Inc., Vienna, VA (US)
Filed by PAK Biosolutions Inc., Vienna, VA (US)
Filed on Nov. 30, 2020, as Appl. No. 17/106,679.
Prior Publication US 2022/0168668 A1, Jun. 2, 2022
Int. Cl. B01D 17/02 (2006.01); B01J 20/281 (2006.01); B01J 39/00 (2006.01); B01J 41/00 (2006.01); C07K 1/16 (2006.01); C07K 1/34 (2006.01); C07K 1/36 (2006.01)
CPC B01D 17/0202 (2013.01) [C07K 1/16 (2013.01); C07K 1/34 (2013.01); C07K 1/36 (2013.01); B01D 2221/08 (2013.01); B01J 20/281 (2013.01); B01J 39/00 (2013.01); B01J 41/00 (2013.01)] 18 Claims
OG exemplary drawing
 
1. 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.