Thermal Microscopy at the Forefront
Lyophilization, or freeze-drying, is a crucial process technology for many parenteral drugs, and an essential part of extending product shelf life. Lyophilization can be a costly, complex, and labor-intensive application. With a flood of protein-based therapeutics and other injectable products in the drug development pipeline—it is expected that 40% of approved new molecular entities (NME’s) in the next five years will require lyophilization—there is a real need for leaner, more efficient freeze-drying methods. To minimize cost and streamline the lyophilization process, many manufacturers are finding it in their best interest to optimize their lyophilization cycles by looking at pre-lyophilization methods such as freeze-dry microscopy.
Freeze-dry microscopy focuses on the direct examination of freezing and freeze-drying via a special microscope and thermal stage. It allows formulators to determine how their products will react in varying thermal conditions using small samples, instead of wasting large quantities of products by freezing them at less than optimal temperatures.
McCrone Microscopes & Accessories has optimized the freeze-dry microscope by coupling a customized Nikon polarized light microscope with a state-of-the-art Linkam thermal stage, and digital microscope camera. Using the Linkam FDCS freeze-drying cryostage, it is now possible to quickly and accurately determine collapse and eutectic temperature and intricately investigate freeze dried structure of complex samples.
Freeze-dry microscopy, as part of a complete thermal-analysis study, is an invaluable tool in the characterization of the thermal properties of any formulation. The process enables pharmaceutical companies to save a significant amount of time and money both in process development and in commercial manufacturing.