Abstract: The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the number of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).

Abstract: The spray dried plasma by the nature of its characteristics and the process by which it is made allows for a dried plasma with reduced pathogens. It has at least three aspects of pathogen reduction that results in a plasma product with reduced or no pathogens. The first aspect relates to a spray drying disposable and machine that eliminates or minimizes the introduction of pathogens into the spray drying process and is referred to as the anti-contamination process. The second aspect of pathogen reduction relates to the spray drying process and parameters that reduces pathogens that may be present in the donor plasma, and/or inhibit pathogen growth and/or pathogen proliferation introduced by the donor plasma. The third aspect results in reduced pathogens occurring during storage of the dried plasma wherein the manufacturing and storage conditions are such that pathogens are reduced, and/or pathogen growth and/or pathogen proliferation are inhibited.

Abstract: The present invention includes a spray drying disposable device for use in a spray drying system. The disposable has a spray drying head and a plasma drying chamber. The head has a spray dry nozzle assembly in fluid communication with the plasma source and the pressurized aerosol gas source. The pressurized gas flows in a vortex pattern that atomizes plasma droplets in the chamber. The head also includes a plenum has uniform air pressure of the drying gas. A baffle plate forms the floor of the plenum having drying gas jets that supply drying gas to the chamber. The atomized plasma droplets evaporate in the presence of the drying gas emitted from the jets to obtain dried plasma particles and humid air. A capture filter captures the dried plasma particles and allows the humid air to pass. The humid air passes through the gas outlet and the exhaust port.

Abstract: The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the mean size of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment.

Abstract: The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the number of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).

Abstract: The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the number of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).

Abstract: The present invention includes a spray drying disposable device for use in a spray drying system. The disposable has a spray drying head and a plasma drying chamber. The head has a spray dry nozzle assembly in fluid communication with the plasma source and the pressurized aerosol gas source. The pressurized gas flows in a vortex pattern that atomizes plasma droplets in the chamber. The head also includes a plenum has uniform air pressure of the drying gas. A baffle plate forms the floor of the plenum having drying gas jets that supply drying gas to the chamber. The atomized plasma droplets evaporate in the presence of the drying gas emitted from the jets to obtain dried plasma particles and humid air. A capture filter captures the dried plasma particles and allows the humid air to pass. The humid air passes through the gas outlet and the exhaust port.

Abstract: The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the number of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).

Abstract: The present invention includes a spray drying disposable device for use in a spray drying system. The disposable has a spray drying head and a plasma drying chamber. The head has a spray dry nozzle assembly in fluid communication with the plasma source and the pressurized aerosol gas source. The pressurized gas flows in a vortex pattern that atomizes plasma droplets in the chamber. The head also includes a plenum has uniform air pressure of the drying gas. A baffle plate forms the floor of the plenum having drying gas jets that supply drying gas to the chamber. The atomized plasma droplets evaporate in the presence of the drying gas emitted from the jets to obtain dried plasma particles and humid air. A capture filter captures the dried plasma particles and allows the humid air to pass. The humid air passes through the gas outlet and the exhaust port.

Abstract: The present invention includes an ease-of-use system that allows the spray drying disposable device to fit (e.g., align) in both spray drying apparatus and the spray drying finishing apparatus to safely operate the system. The system includes locating arrangements between the spray drying disposable and the spray drying apparatus and/or spray drying finishing apparatus, a first retainer and second retainer, a shorter disposable device that allows for effective spray drying of plasma, a feedback indicators of correct installment, redundant indicators of correct installment, easily accessible operator controls and emergency shut offs.

Abstract: The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the number of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).

Abstract: The present invention relates to spray drying plasma methodology that includes pretreating a donated liquid plasma unit, drying the liquid plasma using a spray drying apparatus with the spray drying disposable device that results in a disposable having the dried plasma, finishing the disposable using the finishing apparatus that is designed to seal and separate the disposable, and transform the disposable into a dried plasma unit. The methods of the present invention include storing the dried plasma unit and, when ready for use, reconstituting the dried plasma unit with reconstitution solution to obtain a plasma unit ready for transfusion into a recipient.

Abstract: An alignment system that allows a spray drying disposable to align in both spray drying apparatus and finishing apparatus. The first instance is a locating arrangement wherein a locator is disposed on the spray drying apparatus and/or finishing apparatus and another locator is on the spray drying head of the disposable such that the locators allow for alignment of the disposable with the spray drying apparatus or finishing apparatus. A second instance of an alignment element includes a guide that is offset as positioned on the spray drying head of the disposable. Yet a third instance of the alignment arrangement relates to the gas exhaust port. In a fourth instance, the alignment system includes a positioning arrangement to reversibly attach the outer wall of the disposable to the finishing apparatus. In a fifth and sixth instance, a retaining device that retains the spray drying head in the spray drying apparatus and/or finishing apparatus.

Abstract: The present invention includes a spray drying disposable device for use in a spray drying system. The disposable has a spray drying head and a plasma drying chamber. The head has a spray dry nozzle assembly in fluid communication with the plasma source and the pressurized aerosol gas source. The pressurized gas flows in a vortex pattern that atomizes plasma droplets in the chamber. The head also includes a plenum has uniform air pressure of the drying gas. A baffle plate forms the floor of the plenum having drying gas jets that supply drying gas to the chamber. The atomized plasma droplets evaporate in the presence of the drying gas emitted from the jets to obtain dried plasma particles and humid air. A capture filter captures the dried plasma particles and allows the humid air to pass. The humid air passes through the gas outlet and the exhaust port.

Abstract: The present invention includes a spray drying disposable device for use in a spray drying system. The disposable has a spray drying head and a plasma drying chamber. The head has a spray dry nozzle assembly in fluid communication with the plasma source and the pressurized aerosol gas source. The pressurized gas flows in a vortex pattern that atomizes plasma droplets in the chamber. The head also includes a plenum has uniform air pressure of the drying gas. A baffle plate forms the floor of the plenum having drying gas jets that supply drying gas to the chamber. The atomized plasma droplets evaporate in the presence of the drying gas emitted from the jets to obtain dried plasma particles and humid air. A capture filter captures the dried plasma particles and allows the humid air to pass. The humid air passes through the gas outlet and the exhaust port.

Abstract: A fuel cell system includes a fuel cell. The fuel cell includes an anode having an anode inlet configured to receive anode feed gas, and an anode outlet configured to output anode exhaust. The fuel cell further includes a cathode having a cathode inlet and a cathode outlet. The fuel cell system further includes an anode blower configured to receive the anode exhaust and output a higher-pressure anode exhaust. The fuel cell system further includes an anode blower recycle line configured to receive a portion of the higher-pressure anode exhaust downstream from the anode blower and to output the portion of the higher-pressure anode exhaust upstream from the anode blower. The fuel cell system further includes a first valve disposed in the blower recycle line, the first valve configured to open when the anode of the fuel cell is under-pressurized.

Abstract: A fuel cell system includes a fuel cell. The fuel cell includes an anode having an anode inlet configured to receive anode feed gas, and an anode outlet configured to output anode exhaust. The fuel cell further includes a cathode having a cathode inlet and a cathode outlet. The fuel cell system further includes an anode blower configured to receive the anode exhaust and output a higher-pressure anode exhaust. The fuel cell system further includes an anode blower recycle line configured to receive a portion of the higher-pressure anode exhaust downstream from the anode blower and to output the portion of the higher-pressure anode exhaust upstream from the anode blower. The fuel cell system further includes a first valve disposed in the blower recycle line, the first valve configured to open when the anode of the fuel cell is under-pressurized.

Abstract: A fuel cell system includes a fuel cell. The fuel cell includes an anode having an anode inlet configured to receive anode feed gas, and an anode outlet configured to output anode exhaust. The fuel cell further includes a cathode having a cathode inlet and a cathode outlet. The fuel cell system further includes an anode blower configured to receive the anode exhaust and output a higher-pressure anode exhaust. The fuel cell system further includes an anode blower recycle line configured to receive a portion of the higher-pressure anode exhaust downstream from the anode blower and to output the portion of the higher-pressure anode exhaust upstream from the anode blower. The fuel cell system further includes a first valve disposed in the blower recycle line, the first valve configured to open when the anode of the fuel cell is under-pressurized.

Abstract: A mixer/eductor assembly for use with a fuel cell stack having an anode-side and a cathode-side, said mixer/eductor assembly mixing and at least partially combusting anode exhaust gas output from the anode-side and an oxidant supply gas, said mixer/eductor assembly comprising: a first area receiving and mixing a first portion of the anode exhaust gas and a first portion of the oxidant supply gas to form a first mixture, the first area being configured so as to initiate a combustion reaction in the first mixture; a second area coupled with the first area, the second area receiving to and mixing a second portion of the anode exhaust gas and a second portion of the oxidant supply gas to form a second mixture, wherein: the first mixture has a predetermined oxidant to fuel ratio smaller than the oxidant to fuel ratio of the second mixture; and the first area provides an ignition source to promote continuous combustion of the second mixture in the second area.

Abstract: A duct for a fuel cell module includes an upper duct hood having an inlet configured to receive reactant gas from a supply duct, the upper duct hood defining a first tapered portion and a second tapered portion. The duct further includes a lower duct hood fluidly coupled to the upper duct hood, the lower duct hood defining at least one outlet. In a side view, the second tapered portion is tapered inwardly in a downstream direction. In a top view, the first tapered portion is tapered inwardly in a downstream direction, and the second tapered portion is tapered outwardly moving downstream.