BioProcess International Publication
Validation of Controlled Freezing and Thawing: A 9-L Bottle Study
Whitepaper by Jerry King

Validation of Controlled Freezing and Thawing: A 9-L Bottle Study

Photo 1: Standard one-bottle position in chamber

Photo 1: Standard one-bottle position in chamber

Freeze–thaw processes affect the quality of biopharmaceutical proteins (113) and human cells (14). It has been reported that no method consistently controls freezing and thawing rates for biological formulations (1). My recent study refutes that claim with validated rate-controlled freezing and thawing of such formulations in 16-L single-use bags (15).

The study reported herein presents a consistent method for controlled-rate freezing and thawing of bottled formulations. It also highlights the effect of load and container position on freeze rates. The freeze–thaw controlled-rate chamber used in this study is a Model 4002 manufactured by Farrar Scientific. It permits rapid, uniform bulk freezing/ thawing of products with temperature ranges from 40 °C to –80 °C. The model has a minimum of 1.7 kW of net cooling and heating capacity over its entire temperature range. Units come equipped with programmable profiles that allow flexibility to meet unique product conditioning.

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