at Purdue University
Lyo2040 Lyophilization and Freeze-Thaw Technology Roadmap for Pharma/Biotech Manufacturing
The goal of this roadmap is to identify drying and other preservation technologies that are needed to advance the safety, quality and availability of medicines produced by the U.S. pharmaceutical and life sciences industries.
Expanding the 2017 LyoHUB Technology Roadmap
With a 2022 award from the National Institute of Standards and Technology’s (NIST) Advanced Manufacturing Technology Roadmap Program (MFGTech), Purdue University/LyoHUB has worked with an extensive network of experts in industry, academia and government to develop a Lyophilization, Freeze-Thaw and Aseptic Drying Technology Roadmap for Pharma/Biotech Manufacturing. This new roadmap expands the 2017 LyoHUB technology roadmap to include:
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Education/Workforce
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New Product Modalities (including Drug/Medical Device Products - mRNA, Cell & Gene therapies)
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Automation and Digitalization (PAT/Process Optimization/Automation/Modeling)
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Freeze/Thaw Preservation
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Advanced Drying Technologies: Dehydration or Drying (Alternatives to the existing Vial FD Batch Process)
What is Lyophilization?
Lyophilization, often referred to as freeze-drying, is a method used to preserve perishable materials, such as food, pharmaceuticals, and biological samples, by removing moisture through sublimation under vacuum conditions. This process involves freezing the material and then subjecting it to a vacuum, allowing the frozen water to transition directly from a solid to a gas without passing through the liquid phase, thereby preserving the material's structure and integrity.
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Lyophilization removes water by sublimation to produce a dry powder. In sublimation, frozen water (ice) is converted to water vapor without first melting to liquid water. Sublimation of water occurs at low temperature and low pressure (unlike dry ice).
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The three phases of a lyophilization cycle are: Freezing, Primary Drying and Secondary Drying. During Freezing, a solution of the drug is solidified by decreasing the temperature, usually at atmospheric pressure. Next, during Primary drying, water is removed from the frozen solid by sublimation at low temperature and low pressure. Finally, in Secondary drying, unfrozen water is removed, usually at a temperature and pressure somewhat higher than in primary drying
Lyophilization Facts
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.
