A comparison of conventional and controlled freezing methods

BIOT 474

Matt Olsen, molsen@integratedbio.com, Stedim Biosystems North America, 445 Devlin Rd., Napa, CA 94558
Conventional freeze thaw techniques at production scale can present challenges to biologics during processing due to macroscopic freeze concentration of solutes. This effect results in solute concentration changes occurring differentially throughout the frozen volume. Controlled freezing is presented as a method capable of minimizing this macroscopic freeze concentration in production volume equipment. The effects of each method of freezing on the distribution of protein and solutes present in freezing containers have been examined. The concentration distribution has been found to vary significantly depending upon the type of freezing employed as well as the process scale.