Abstract: The present invention provides a system for freezing, thawing, and storing biopharmaceutical materials which includes a flexible container, a conduit, and a temperature control unit. The flexible container is adapted to receive a biopharmaceutical material therein for freezing, thawing, and storing. The container is formed of a first substantially flat sheet of flexible material joined together by a seam with a second substantially flat sheet of flexible material so as to lie substantially flat when empty. The container fully encloses an interior portion for receiving the biopharmaceutical material. Also, the container is configured to form a three dimensional shape when filled with the biopharmaceutical material, wherein the three dimensional shape has a first side and a second side opposite the first side. The conduit is connected to the flexible container with the outside of the container being in fluid communication with the interior portion via the conduit.

Abstract: A biopharmaceutical cryopreservation system includes a container having an outer surface area with the container being adapted to contain a biopharmaceutical material for freezing and thawing therein. The container may be received in a cryocooling enclosure having an interior cavity configured to receive it. The cryocooling enclosure includes at least one heat transfer surface configured to contact the outer surface area of the container when the cryocooling enclosure interior cavity receives the container. Also, a cryocooler is thermally coupled to the cryocooling enclosure and is configured to flow a fluid to the at least one heat transfer surface to control the temperature of the heat transfer surface and the biopharmaceutical material within the container. The fluid is isolated from contacting the container. Further, a temperature sensor is thermally coupled to the cryocooling enclosure, the at least one heat transfer surface, the fluid and/or the cryocooler.

Abstract: Disclosed is a biopharmaceutical material cryopreservation system that includes a flexible sterile container comprising a biocompatible polymeric material, and the flexible sterile container containing biopharmaceuticals materials, and a freezing system thermally coupled to the biopharmaceutical materials via the flexible sterile container, and the freezing system comprising a temperature sensor that monitors a temperature of the biopharmaceutical materials wherein the freezing system comprises a feedback loop constructed to control a dendritic freezing front velocity, within the biopharmaceutical materials, in a range from approximately 5 millimeters per hour to approximately 250 millimeters per hour based on feedback information from the temperature sensor.

Abstract: A biopharmaceutical material cryopreservation system, including a flexible sterile container comprising a biocompatible polymeric material, and the flexible sterile container containing biopharmaceuticals materials, and a freezing system removably coupled to the flexible sterile container via a tapered slot and the freezing system thermally coupled to the biopharmaceutical materials via the flexible sterile container and the tapered slot; wherein the freezing system comprises a feedback loop constructed to control a dendritc freezing front velocity, within the biopharmaceutical materials, in a range from approximately 5 millimeters per hour to approximately 250 millimeters per hour based on feedback information from the temperature sensor. Also disclosed are methods of cryopreservation of biopharmaceutical materials, and methods of linearly scaling processes for cryopreservation of biopharmaceutical materials.

Abstract: Disclosed is a biopharmaceutical product cryopreservation system, for cryopreserving a biopharmaceutical product that includes a cryopreservation compartment; a cryopreservation fluid located within the cryopreservation compartment; and a biopharmaceutical product cryopreservation vial located within the cryopreservation compartment and surrounded by the cryopreservation fluid, and the biopharmaceutical product cryopreservation vial including a body that includes an oblong cross-section defining proximal and distal ends of the body, and at least one nucleating structure, coupled to a distal end of the body, and the body including a cryogenically stable material that is compatible with biopharmaceutical products. Also disclosed are cryopreservation vials and methods of cryopreserving biopharmaceutical products.

Abstract: The present invention relates to a biopharmaceutical preservation system for cooling, thawing and freezing a medium. The biopharmaceutical preservation system includes a vessel and a structure removably mounted within the vessel. The structure includes an elongated pipe centrally positioned within the vessel and having one or more heat transfer members.

Abstract: The present invention relates to a biopharmaceutical preservation system for cooling, thawing and freezing a medium. The biopharmaceutical preservation system includes a structure having has one or more heat transfer members placed inside a vessel. The structure includes a dual flow conduit adapted to be actively cooled using a fluid.

Abstract: The present invention relates to a thermal transfer system for heating or cooling a medium. A structure positioned inside a container. The structure segments the container into a plurality of compartments wherein a distal end of the structure is in close proximity to an interior surface of the container to allow formation of a thermal transfer bridge that conducts heat into or out of the medium.

Abstract: Disclosed is a biopharmaceutical product cryopreservation system, for cryopreserving a biopharmaceutical product that includes a cryopreservation compartment; a cryopreservation fluid located within the cryopreservation compartment; and a biopharmaceutical product cryopreservation vial located within the cryopreservation compartment and surrounded by the cryopreservation fluid, and the biopharmaceutical product cryopreservation vial including a body that includes an oblong cross-section defining proximal and distal ends of the body, and at least one nucleating structure, coupled to a distal end of the body, and the body including a cryogenically stable material that is compatible with biopharmaceutical products. Also disclosed are cryopreservation vials and methods of cryopreserving biopharmaceutical products.

Abstract: Disclosed are bulk lyophilization containers including aseptic closure portions or heat flux equalization portions that promote improved bulk lyophilization. Also disclosed are methods of using the bulk lyophilization containers and improved lyophilization stoppers.

Abstract: Disclosed are bulk lyophilization containers including aseptic closure portions or heat flux equalization portions that promote improved bulk lyophilization. Also disclosed are methods of using the bulk lyophilization containers and improved lyophilization stoppers.

Abstract: The present invention relates to a thermal transfer method for heating or cooling a biopharmaceutical medium. A structure is positioned in the container. A heat exchange member is coupled to an interior surface of the container wherein a distal end of the heat exchange member is placed in close proximity to the structure to allow formation of a thermal transfer bridge that conducts heat into or out of the medium.

Abstract: The present invention is a system and method for freeze granulation of a medium such as a biopharmeceutical product. The medium is put into a chamber and mixed using a pair of counter rotating agitators. The agitators have angled blades or paddles on them in order to induce motion in the medium parallel to the axis of the agitator shafts. A set of liquid nitrogen and liquid carbon dioxide nozzles are attached to the chamber. The liquid nitrogen nozzles spray a mist of liquid nitrogen into the medium. The liquid carbon dioxide nozzles spray carbon dioxide snow into the chamber. The liquid nitrogen and the carbon dioxide can be sprayed into the chamber at the same time or alternately.

Abstract: The present invention is a system and method for freeze granulation of a medium such as a biopharmeceutical product. The medium is put into a chamber and mixed using a pair of counter rotating agitators. The agitators have angled blades or paddles on them in order to induce motion in the medium parallel to the axis of the agitator shafts. A set of liquid nitrogen and liquid carbon dioxide nozzles are attached to the chamber. The liquid nitrogen nozzles spray a mist of liquid nitrogen into the medium. The liquid carbon dioxide nozzles spray carbon dioxide snow into the chamber. The liquid nitrogen and the carbon dioxide can be sprayed into the chamber at the same time or alternately.

Abstract: The present invention is a system and method for freeze granulation of a medium such as a biopharmeceutical product. The medium is put into a chamber and mixed using a pair of counter rotating agitators. The agitators have angled blades or paddles on them in order to induce motion in the medium parallel to the axis of the agitator shafts. A set of liquid nitrogen and liquid carbon dioxide nozzles are attached to the chamber. The liquid nitrogen nozzles spray a mist of liquid nitrogen into the medium. The liquid carbon dioxide nozzles spray carbon dioxide snow into the chamber. The liquid nitrogen and the carbon dioxide can be sprayed into the chamber at the same time or alternately.

Abstract: An information processor is described which is especially suitable for efficiently sorting large quantities of binary data. Data in a plurality of storage devices is fed to a plurality of compare-exchange modules and is then selectively passed back to the storage devices by means of multi-input switches. A programmable microprocessor controls passage of data through the various components in an iterative process.

Abstract: A dynamic memory is disclosed, in which data is rearranged among its internal memory locations in accordance with either of two different shuffle operations. The shuffle operations, an In Shuffle and an Out Shuffle, rearrange the data in a manner similar to the manner in which cards of a deck are rearranged when shuffled. Using only the two shuffle operations, a method of random accessing data in the theoretical minimum time is disclosed, for all odd-sized memories and all memories of size 2.sup.r. Once a desired datum has been accessed, successive data can be sequentially accessed in unit time. Processes for sequential accessing of data are shown to be related to the existence of sequences of In and Out Shuffles which move each datum through the read/write window of the memory, which sequences are defined as tours. A method for determining the existence of and for constructing tours for certain sized memories is also disclosed.