Thermally Insulated Transport Container For Cell-Based Products and Related Methods
AssigneeGenzyme Corporation
InventorsAdam Heroux, Barbara Seymour
Life of this patent
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Abstract
The present invention provides a temperature sensitive transport container (20) for packaging and shipping cell-based products such as cultured cells intended for transplantation. In particular, the present disclosure provides a thermally insulated transport container system (10) for storing and transporting cells for transplantation which is capable of maintaining the cells at a desirable temperature range for a sufficient period of time to ensure adequate cell viability and therapeutic properties.
Claims56
A thermally insulated transport container system, comprising:
- a closable container having a thermally insulated portion, the container being configured for storage or shipment of a skeletal myoblast cell-based product;
- a sealable canister within the container, the canister being configured for holding the skeletal myoblast cell-based product;
- and
- a refrigerant within the container, the refrigerant being configured to maintain an internal temperature in the canister in the range of −5° C. to 15° C. for a period of at least 72 hours.
A method of shipping cultured cells for transplantation, comprising:
- providing a closable container having a thermally insulated portion, the container being configured for storage or shipment of a skeletal myoblast cell-based product;
- providing a skeletal myoblast cell-based product in a sealed canister configured for holding cell-based products;
- placing the sealed canister into the container;
- providing a refrigerant for the container, the refrigerant being configured to maintain an internal temperature of the canister in the range of −5° C. to 15° C. for a period of at least 72 hours;
- and
- closing the container.
A method of transporting cell-based therapy products to a recipient, comprising:
- maintaining a cell-based therapy product at a temperature range of −1° C. to 6° C. during transportation for a duration of at least 48 hours, the cell-based therapy product being suspended in medium and configured for transplantation, and
- delivering the cell-based therapy product to the recipient in therapeutically acceptable condition.
A method for validating temperature stability during a shipping cycle for a closed container shipping system containing an item for delivery comprising:
- determining a duration of time for shipment of the item to a recipient;
- determining a desired temperature range for the item to be delivered;
- preparing a hot temperature shipping profile for the item to be delivered, the profile spanning at least the determined duration of time;
- preparing a cold temperature profile for the item to be delivered, the profile spanning at least the determined duration of time;
- maintaining the item to be delivered under conditions simulating the environmental temperatures of the hot temperature shipping profile or the cold temperature profile for at least the determined duration of time;
- and
- comparing the temperatures of the hot or cold shipping profiles to the desired temperature range.
Dependencies are inferred from the claim text.