Abstract:
A high pressure valve includes a lever and a variable force generator for facilitating control of opening and closing the valve at high pressures. The high pressure valve includes a housing having a chamber providing fluid communication between a first port and a second port, a pin movable within the chamber between an open position and a closed position. A first end of a lever is coupled to the pin and a second end of the lever is coupled to a variable force generator. The lever pivots about a pivot point. A controller coupled to the variable force generator is configured to adjust a force applied to the second end of the lever by the variable force generator to control the movement of the pin between the open position and the closed position.
Abstract:
Devices and methods for sample preparation via pressure cycling technology are disclosed. The device for sample preparation comprises a tube having an inner surface, a top, and a bottom, the tube configured to contain a sample at the bottom and to be received into a pressure chamber for sample preparation, a cap detachably connected to the top of the tube, and a tapered elongate member extending from the cap into the tube, the tapered elongate member configured to contact the inner surface of the tube and the sample in the bottom of the tube, wherein the tube is deformable such that in operation under pressure the tube is deformed against the tapered elongate member to promote disruption of the sample.
Abstract:
Described herein is a sample preparation device including a sample delivery source, an inline means of transferring the sample from the sample source into a deformable channel within a pressure vessel, and out of the channel into downstream analysis components, a deformable channel disposed within the pressure vessel, the deformable channel having an inlet end and an outlet end fluidly connectable to high pressure valves and a means to measure the fluid pressure within the deformable channel, an external source of a controlled pressurized fluid fluidly connectable to the pressure vessel and a controller system that monitors and controls the sample fluid pressure by control of the external pressure vessel fluid.
Abstract:
The present invention provides methods for reducing and/or evaluating the immunogenic potential of a therapeutic protein preparation. The present invention further provides pharmaceutical compositions of therapeutic proteins and methods of treatment with the same, the compositions having low immunogenic potential and/or improved efficacy. The invention achieves these goals by evaluating therapeutic protein preparations for subvisible protein particulates, which can contribute significantly to the overall immunogenic potential of the protein preparation. Further, by maintaining the content of such subvisible protein particulates to below an immunogenic threshold level, the resulting pharmaceutical composition is less likely to result in a loss of tolerance (e.g., upon repeated administration), thereby improving both the safety and efficacy profile of the therapeutic.
Abstract:
A method for high fluid shear processing of a fluid uses an isolator that has a first sub-chamber for containing a first fluid and a second sub-chamber for containing a second fluid defined by a separator positioned in the chamber and movable between a first end of the chamber and a second end of the chamber. The two sub-chambers are in pressure communication with each other but are not in fluid communication with each other. A first fluid is pumped at an ultrahigh pressure into the first-sub chamber, and the pressure in the first sub-chamber causes a second fluid to be processed to be discharged from the second sub-chamber into a processing valve. A system is also provided for performing the steps of this method.