Freezing, Biopharmaceutical Products

During the manufacturing process of biopharmaceutical products, freeze/thaw of protein solutions are routine operations, allowing product shelf-life to be extended and providing flexibility in the scheduling of the final fill and finish steps. This article discusses the physics of freezing and thawing, the multiple stresses that can affect protein stability during these operations and the strategies that can be used to mediate these problems. Keywords: freezing; thawing; protein solution; cryoconcentration; freeze-concentration; protein stability