Method and system for controlled rate freezing of biological material

摘要

A method and system for controlled rate freezing of biological materials is provided. The presently disclosed system and method provides the ability to rapidly cool the biological materials contained in vials or other containers within a cooling unit via forced convective cooling using a laminar and uniform flow of cryogen in proximity to the plurality of vials disposed within the cooling unit. The rapid cooling of the biological materials is achieved by precisely controlling and adjusting the temperature of the cryogen being introduced to the system as a function of time.

主权项

1. A controlled rate cryogenic chiller or freezing system for biological solutions or biopharmaceutical materials contained in a plurality of vials or containers, comprising:
a cryogen source; an intake circuit coupled to the cryogen source and adapted for providing a uniform flow of a cryogen cold gas to a cooling chamber; the cooling chamber comprising an intake plenum having a base gas injection box and a first porous plate or perforated plate disposed on a surface of the gas injection box, an exhaust manifold having a gas removal box of similar size to the base gas injection box and disposed proximate to the base gas injection box and a second porous plate or perforated plate disposed therein, the second porous plate or perforated plate being parallel and opposing to the first porous plate or perforated plate, and wherein the first and second parallel and opposing porous plates or perforated plates are of similar size and configuration and define a cooling area therebetween; an exhaust circuit adapted to remove the cryogen gas from the exhaust manifold of the cooling chamber; and a control system that adjusts the flow rates of the cryogen source in the intake circuit and any cryogen gas in the exhaust circuit to adjust the temperature of the cold cryogen gas delivered to the cooling chamber in response to a desired cooling rate of the biological solutions or biopharmaceutical materials and measured temperatures within the cooling chamber; wherein the biological solutions or biopharmaceutical materials contained in the plurality of vials or containers are spaced apart on at least one of the parallel and opposing porous plates or perforated plates; and wherein a uniform, uni-directional flow of temperature adjusted cryogenic cold gas is delivered to the cooling area between the parallel and opposing porous plates or perforated plates and along a longitudinal axis of each of the plurality of vials or containers to cool the biological solutions or biopharmaceutical materials at a uniform cooling rate and prevent recirculation of the cryogenic cold gas within the cooling area.