By Jeff Tremain and Ted Tharp
Lyophilization, also known as freeze-drying, is a pivotal operation in the manufacture of solid-dosage drug forms. Used to remove water from a drug product after it has been frozen and placed under a vacuum, it allows drying without the application of heat. Lyophilization ensures drug stability, delivers an extended shelf-life, and enables long-term storage at room temperature. A further advantage of a lyophilized drug product is that it limits the number of interactions between the product and the vial and stopper during the period of storage.
Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on. Partnering with an experienced contract development and manufacturing organization (CDMO) for lyophilization can shorten the drug development process and expedite time to market.