Sartorius Stedim North America Inc.

Integrated Biosystems, Inc.

Sartorius Stedim Fmt Sas

Sartorius Stedim Biotech Gmbh

Sartorius Stedim Freeze Thaw, Inc.

Nicolas Voute

Eric K Lee

Jonathan E Cutting

Isabelle Gay

Richard Wisniewski

Brian J Woodard

David C Brown

Ngee Jenn Lee

Maxime N Lok

Leonidas Cartwright Leonard

James Edward DeBeers

Timothy Gerard Hughes

Dimitry Yakoushkin

Martin Dahlberg

Magnus Andreas Stering

Jonathan N Webb

Hartmut Langer

Brian J Woodward

Eric Lee

A pouch includes: a first closed, inner casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a first space, forming a pouch stricto sensu for accommodating a biopharmaceutical product or device, a second closed, outer casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a second space in which the pouch stricto sensu is located, spacer elements, at least one selected tracer gas, located in the first or second space outside of the pouch stricto sensu, with a higher partial pressure than in the second space outside of the pouch stricto sensu or in the first space, at least one colorimetric detector located, respectively, in the second space outside of the pouch stricto sensu or in the first space responsive to the concentration of the tracer gas, by switching from a first color to a second different color.

Pouch with incorporated loss of integrity indicator, method for making such a bag, and method for using same

A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Systems and methods for freezing, storing and thawing biopharmaceutical materials

A system for use in freezing, storing and thawing biopharmaceutical materials includes a flexible sterile container means for holding biopharmaceutical material therein and a holder more rigid than said container means. The container means is received in a cavity of the holder and the holder extends along a perimeter of the container means. The holder is fixedly connected to the container means. The holder includes opposing sides defining an opening and the container means extends between the opposing sides of the holder defining the opening. The container means includes a substantially smooth exterior surface extending between the opposing sides.

There is a bag () that has at least one lateral gusset () and at least one port (), a source () of pressurized gas, elements () for measuring the pressure of the gas; &#x2014;there are two restraining plates and spacer strips. The bag is placed flat between the two restraining plates (). At least one spacer strip () is inserted between the two small walls of each gusset in order to prevent these walls from resting on one another. The port is connected to the gas source and the pressure measuring elements. The gas is sent under pressure into the bag, the expansion of the bag being limited by the restraining plates; then, the pressure drop in the bag is compared to a predefined threshold.

Method and device for checking the integrity of a flexible, nonporous bag with one or more bellows

A system for use in storing biopharmaceutical materials includes a holder and a container for holding biopharmaceutical materials therein. The container includes a storage portion and a sampling portion connected to each other by a connecting portion. The holder has a storage cavity receiving the storage portion and a sampling cavity receiving the sampling portion. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior storage cradle bounding the storage cavity of the holder. The holder includes an interior sampling cradle bounding the sampling cavity. The sampling cradle is separated from the storage cradle and connected to the storage cradle by a passage receiving the connecting portion connecting the storage portion to the sampling portion. An outer rim of the holder is connected to the cradle and separated from the cavity.

A system for freezing, thawing, transporting, and storing a biopharmaceutical material, which includes a container, a supporting structure, a temperature control unit, and a transportation cart. The container is adapted to receive the biopharmaceutical material therein for freezing, thawing, storing, and transporting, with the container also being receivable in the supporting structure. The temperature control unit has a cavity for receiving the supporting structure, when the supporting structure supports the container, and the transportation cart has a channel for receiving the supporting structure, when the supporting structure supports the container.

Systems and methods for freezing, storing, transporting, and thawing biopharmacuetical material

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

A system for controlled freezing, storing and thawing of a biopharmaceutical material includes a cavity for receiving a container for holding the biopharmaceutical material. Further included are at least a pair of opposed surfaces facing the biopharmaceutical material holding container. At least one of the opposed surfaces includes a moveable contacting surface configured to contact the container to inhibit a clearance between the container and the movable contacting surface. Also included is at least one heat transfer surface which is thermally coupled to the biopharmaceutical material holding container when the moveable contacting surface contacts the container. Also, the cavity may be configured to receive a frame for supporting the container holding the biopharmaceutical material. Further, the system may include a driver to move the frame holding the container inside the cavity.

Systems and methods for freezing, mixing and thawing biopharmaceutical material

Systems and methods for freezing, storing, transporting and thawing biopharmaceutical material

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).

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Cuges les Pins, France

Nicolas Voute