Apparatus and method for freezing biological solutions

Abstract

The present disclosure provides systems and methods for freezing liquid mixtures or suspensions containing sensitive substances, such as biopharmaceutical materials, under sterile conditions and in small volume containers. The disclosed device is capable of controlling ice nucleation of a solution, minimizing frozen bulk layers, while controlling ice growth rate in a bottom-up geometry, and includes a heat transfer surface (101) with a temperature-controlled device for multiple A holder (102) of a container (109), a pressing device (103) for pressing the holder against the heat transfer surface and optional contact promoting material. The disclosed method includes pre-cooling the device to a temperature substantially below the nucleation temperature of the solution, placing the container in a holder, contacting the container with the heat transfer surface until a fraction of 10% of the total sample volume is frozen; contact between the transfer surfaces; contacting the container with the heat transfer surface at a predetermined freezing rate such that the freezing of the biological solution is uniform; until all volumes of the solution are frozen.

Description

technical field [0001] The present disclosure generally relates to an apparatus and method for freezing a liquid mixture or suspension containing a sensitive substance (eg, biological material) in a plurality of small volume containers, particularly wherein the biological material is living cells, blood cells, viruses, proteins, antibodies, etc. Furthermore, the present disclosure improves the reproducibility of nucleation and crystal growth during freezing of small volumes of aqueous mixtures in multiple vessels. Background technique [0002] Cryopreservation of sensitive substances is essential for many applications related to the development of cell biology. Cells or derivatives produced from their culture are typically cryopreserved to manage production and distribution, including reserves for the preservation of their genetic material. [0003] One of the major limitations of existing systems is inconsistency due to the complexities associated with freezing and thawin...

AI Technical Summary

Problems solved by technology

Another important technical difficulty led to the ability to control the nucleation and ice growth rates

In smaller volumes, rapid cooling of the base is required to enhance nucleation at the base, possibly leading to complete uncontrolled freezing of the sample rather than just nucleation

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