Velico Medical, Inc.

Kyle D Erickson

Robert R Andrews

Clair Strohl

Herman E Snyder

Evan P Ordway

William J Merritt

Russell Barron

Qiyong Peter Liu

Jihae Sohn

Lisa A Buckley

Mark A Popovsky

Richard Meehan

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.

Methods for a spray drying system

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.

Usability of a disposable for a spray drying plasma system

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.

Methods for making spray dried plasma

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.

Alignment of a disposable for a spray drying plasma system

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 COor other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).

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Melrose, MA, United States of America

Kyle D Erickson