Integrated Biosystems, Inc.

Other

Sartorius Stedim North America Inc.

Sartorius Stedim Systems Gmbh

Richard Wisniewski

Eric K Lee

Nicolas Voute

Leonidas Cartwright Leonard

Maxime N Lok

Timothy Gerard Hughes

Jonathan N Webb

A system for manipulating and transporting items of various sizes and shapes comprising a carry-all handle having affixed thereto at least two hook and hook-loop fastened strips of length A, and a plurality of additional hook and loop fastener strips of various lengths which can be connected to the strips of length A so that the carry-all handle can be attached to and manipulate items of various sizes and shapes.

Carry-all handle

A freezing and thawing unit for small amounts of biopharmaceuticals and biologics. The freezing and thawing unit is reduced in scale, as compared to a corresponding commercial or large-scale process. The freezing and thawing unit can be used for testing, preservation and/or processing of small quantities of biopharmaceuticals and biologics.

Scaled down freezing and thawing system for biopharmaceuticals and biologics

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. The temperature control unit includes a first surface and a second surface facing the first surface and the temperature control unit is configured to receive the flexible container therein, when the container is filled with the biopharmaceutical material. The container conforms to the shape of the interior of the temperature control unit and the first side and the second side of the container contact the first surface and the second surface of the temperature control unit. The first surface and/or the second surface of temperature control unit include heat transfer surface(s).

Systems and methods for freezing and storing biopharmaceutical material

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.

Cryopreservation vial apparatus and methods

A biopharmaceutical material cryopreservation system is provided that includes a flexible sterile container comprising a biocompatible polymeric material. The flexible sterile container contains biopharmaceuticals materials for freezing and cryopreservation. A freezing system is thermally coupled to the biopharmaceutical materials via the flexible sterile container. The freezing system comprises a temperature sensor that monitors a temperature of the biopharmaceutical materials. Also, 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.

Cryopreservation system with controlled dendritic freezing front velocity

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.

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.

Tapered slot cryopreservation system with controlled dendritic freezing front velocity

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.

Lyophilization apparatus and methods

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.

Freezing and thawing vessel with thermal bridge formed between container and heat exchange member

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.

Growing community of inventors

San Mateo, CA, United States of America

Richard Wisniewski