Bulk freezing of biopharmaceuticals

Abstract

A system and method for bulk freezing is provided. In one embodiment, the system and method for bulk freezing includes a bulk freezing container adapted to hold at least one and preferably a plurality of bags holding a biopharmaceutical liquid. The bulk freezing container includes at least a first and second shelf having corrugations wherein the second shelf is vertically arranged above the first shelf with the bags disposed between the shelves. The bags and the corrugations of the first and second shelves define a plurality of substantially parallel flow channels through which a cryogenic cold fluid or a warming fluid is passed to freeze and / or thaw the biopharmaceutical fluid. In another embodiment, the bulk freezing system and method includes a bulk freezing container with a plurality of adjacent elongated chambers adapted for holding the biopharmaceutical fluid. The adjacent elongated chambers have side walls defining a plurality of substantially parallel flow channels between the plurality of adjacent elongated chambers through which a heat transfer medium is passed for heat exchange through the side walls of the elongated chambers to the fluid within the elongated chambers.

Description

FIELD OF THE INVENTION[0001]This invention relates to systems and methods for bulk freezing / thawing of biopharmaceuticals materials, and more particularly, to systems and methods of bulk freezing that employ a bulk freezing container having a plurality of shelves defining a plurality of parallel flow channels adapted to carry a heat exchange medium through said plurality of flow channels to freeze / thaw bags or containers of the biopharmaceutical materials disposed on the shelves.BACKGROUND[0002]Biopharmaceuticals are often times frozen in bulk form to stabilize the product and build up inventory. When the biopharmaceutical is needed, the frozen product is transferred to a fill and finish operation for subsequent thawing and distribution.[0003]Current bulk freezing systems provide freezing of material in various ways. In a one approach, bottles or containers are simply filled and placed in a freezer. Such an approach is labor intensive and offers little scalability and control over t...

AI Technical Summary

Benefits of technology

The inventor has developed a system that can freeze or thaw fluids using multiple flow channels that can exchange heat with separate volumes. This system is easy to use, can handle large volumes, and provides better control and uniformity during the freezing and thawing process. This invention also minimizes the amount of labor required to handle the fluids.

Problems solved by technology

Such an approach is labor intensive and offers little scalability and control over the freezing and thawing processes.

The resulting uneven cross section down the length of the bag results in differences in the freezing of the material in different sections of the bag.

During each handling stage, the bags are subject to possible damage and / or tearing.

However, bags in contact with the jacketed slots offer the potential for non-uniform heat transfer due to imperfect and / or non-uniform contact between the bags and the jacketed slots.

Each of the above systems is labor intensive and / or prone to damage of filled bags or containers during multiple required handling steps.

Due to non-uniform shapes and thermal contact, the above systems do not facilitate controlled freezing of a material.

This lack of control may result in yield losses of biopharmaceuticals on the order of approximately 5% to 50%.

Furthermore, the above described systems are not easily scaled for larger volumes and do not provide adequate handling controls for the product during freezing, storage, and delivery.

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