How To Optimize Lyophilization With Thermal Analysis

By Neil Demarse, Nicie Murphy, and Morgan Ulrich

Even as lyophilization, also called freeze-drying, is routinely used in the pharmaceutical industry, the process is highly specific and requires a very controlled protocol. Improper procedures can lead to insufficient freezing, overload, or equipment or sample damage. Biological samples are particularly vulnerable to freezing-induced damage that reduces the efficacy and potency of the drug product. Therefore, detailed characterization is crucial to optimize the sample preparation, lyophilization, and product delivery. Thermal analysis, the glass transition temperature, and differential scanning calorimetry are all important points to consider.