at Purdue University
Learn about the Challenges of Lyophilization
Lyophilization is crucial in various industries for preserving sensitive materials that are prone to degradation from heat or moisture. In pharmaceuticals, it is used to extend the shelf life of vaccines, antibiotics, and other drugs, while in the food industry, it preserves the flavor, texture, and nutritional value of fruits, vegetables, and other perishable items.
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Despite its importance, lyophilization poses several challenges. One challenge is the high cost associated with the process, including equipment, energy consumption, and skilled labor. Additionally, the long processing times required for some materials can hinder large-scale production. Furthermore, there are concerns about product stability and maintaining the efficacy of pharmaceuticals during the lyophilization process. Research and development efforts are ongoing to address these challenges and improve the efficiency, cost-effectiveness, and applicability of lyophilization in various industries.
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Lyophilization is also widely used for manufacturing of diagnostic test kits, therapeutic products such as injectable antibiotics, chemotherapies as well as peptides, vaccines and other complex materials. Over 30 new lyophilized products have been approved by the FDA each year since 2016 as compared <10 annually in early 2000s (LyoHUB, 2022). The growing demand for lyophilized products has strained global production capacity, comprising 13% of all products on the FDA’s “in shortage” list in 2021 (FDA, 2023).
Lyophilization has become an increasingly important unit operation in manufacture of injectable therapeutic agents, and its importance is reflected in the growing number of lyophilized drug products approved by the FDA. The preferred presentation of any injectable drug product is a ready-to-use sterile solution, since this presentation is the most convenient to administer, the least costly to manufacture, and has the highest level of sterility assurance. However, many newer large molecule therapeutic agents, such as monoclonal antibodies, antibody/drug conjugates, and fusion proteins are not stable enough in solution to allow a solution drug product. Freeze-drying offers an elegant way around this stability problem by first freezing the solution, then applying a vacuum to facilitate water removal by sublimation. The resulting sterile solid is quickly and easily reconstituted, or re-hydrated, by addition of water and gentle agitation. Lyophilization is compatible with preparation of highly concentrated formulations, which enables minimizing the volume injected, making for more convenient administration.
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As pharmaceutical research and development continues to introduce new therapeutic agents, lyophilization will remain a crucial tool in meeting the evolving demands of the healthcare landscape.