Walking on thin ice: controlled freezing & thawing of pharmaceutical active molecules

Abstract

Cryopreservation of active pharmaceutical ingredients, cells, or tissues is fundamental to maintain the quality of the respective product. Ice formation, re-crystallization, and other phenomena that occur during the freezing and thawing process can cause significant damage. These ice-induced injuries can be minimized by appropriate molecule design and the use of chemical cryoprotectants or bio-substances in combination with suitable equipment and physical conditions during the freezing and thawing process. It is important to adapt both freezing and thawing processes to the characteristics of the protein or active pharmaceutical ingredient that requires a cold chain to maintain its biological and chemical stability during storage and shipment. Controlled freezing and thawing facilitates consistent product quality during the fluid management processes involved in manufacturing. By preventing damage to active ingredients, the supply of medications is optimized.