Spray dried human plasma

Abstract

The technology relates to spray dried plasma and methods of making the same. The method includes providing plasma to a spray drying apparatus, spray drying the plasma, at the spray drying apparatus, to form physiologically active plasma powder, the spray drying apparatus configured utilizing one or more parameters, and storing the physiologically active plasma powder.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This application is a continuation of U.S. patent application Ser. No. 13 / 556,834, filed on Jul. 24, 2012, which is a continuation application of U.S. patent application Ser. No. 12 / 884,052, filed on Sep. 16, 2010 which claims priority to U.S. Provisional Patent Application No. 61 / 243,034, filed Sep. 16, 2009, the entire contents of which are incorporated in their entirety herein by reference.FIELD OF THE INVENTION[0002]The present invention relates generally to methods and apparatus for producing and / or using spray dried human plasma.BACKGROUND[0003]Blood plasma is the yellow liquid component of blood, in which the blood cells of whole blood would normally be suspended. Blood plasma makes up about 55% of the total blood volume. Blood plasma is mostly water (e.g., 90% by volume) and contains dissolved proteins, glucose, clotting factors, mineral ions, hormones, and / or carbon dioxide. Blood plasma is prepared by spinning a tube of fresh blo...

AI Technical Summary

Benefits of technology

The present invention provides an extracorporeal sterile, closed plasma processing system that can produce a spray dried, physiologically active plasma powder product that has a long storage life at room temperature, is versatile, durable, and simple. The processing system can produce spray dried plasma in either a batch or continuous mode, and the resulting plasma powder can be stored at least 2-3 years at virtually any temperature. The costs associated with storage and shipping of the spray dried powder are significantly lower compared to frozen plasma. The spray dried plasma powder can be rapidly reconstituted and used at the point of care, avoiding the need for special equipment and trained staff. The plasma spray drying techniques described herein have advantages such as not overheating the plasma, allowing for future use without refrigeration, and controlling the process parameters for scaling the quantity of processed plasma.

Problems solved by technology

Although frozen plasma is the current standard of care, there are numerous problems with this technology.

For example, the bag containing the frozen plasma become brittle and often gets damaged during storage or transportation.

Maintaining frozen plasma at the appropriate temperature during storage and transportation is very expensive.

Finally, fresh frozen plasma has a limited shelf life of 12 months at −18° C. Once thawed, the frozen plasma must be used within 24 hours.

However, the freeze drying process produces a product composed of large, irregular sized grains or particles.

Such products can be difficult or impossible to reconstitute to a form suitable for administration to a patient.

Furthermore, the freeze drying process requires transfer of the product from the lyophilizer to the final container, thus requiring post-processing sterility testing.

The freeze drying process can only be done in batch mode; continuous processing is not possible with freeze drying.

Moreover, manufacturing scale-up requires changes to the freeze drying process, and there are protein recovery issues at scale-up.

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