Device and method for freezing a biological solution

Abstract

The present disclosure provides systems and methods for use in freezing liquid mixtures or suspensions containing sensitive substances, such as biopharmaceutical materials, under sterile conditions and in small-volume containers. The disclosed device enables the control of ice nucleation of the solution minoring the layer of volume that freezes, while controlling the ice growth rate in a bottom up geometry, and comprises a heat transfer surface (101) with means to control temperature, a holder (102) for multiple containers (109), pressing means (103) to press the holder against the heat transfer surface and optionally a contact promoting material. The disclosed method comprises pre-cooling the device to a temperature substantially below the solution nucleation temperature, placing a container into the holder, contacting the container with the heat transfer surface until a fraction of 10% of the total sample volume is frozen; interrupting the contact between the container and the heat transfer surface; and contacting the container with the heat transfer surface at a predefined freezing rate, such that the freezing of the biological solution is homogeneous, until all the volume of the solution is frozen.

Description

technical field [0001] The present disclosure generally relates to an apparatus and method for freezing liquid mixtures or suspensions containing sensitive substances, such as biological material, in particular 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 containers. Background technique [0002] Cryopreservation of sensitive substances is essential for many applications, relevant to the development of cell biology. Cells or derivatives resulting from their culture are usually cryopreserved to manage production and distribution, including stockpiling 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 thawing phenomena. Due to therapeutic and safety constraints, this is es...

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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