Advanced Lyophilization Technology Hub an industry-led partnership to advance the science and technology of lyophilization/freeze-drying. 

The goal of Advanced Lyophilization Technology Hub (LyoHUB) is to advance the science and technology of freeze-drying/lyophilization. LyoHUB’s members include companies in the pharmaceutical and food processing sectors, equipment manufacturers and university researchers, who combine their expertise and resources to accomplish the goal. Immediate objectives are:  (i) to identify and disseminate Best Practices for lyophilization equipment performance, testing and validation and (ii) to conduct applied research to advance lyophilization processes and products. 



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  • Now available from LyoHUB in Open Source: Practical Advice on Scientific Design of Freeze‑Drying Process: 2023 Update

    The purpose of this paper is to revisit the design of three steps in the freeze-drying process: freezing, primary drying, and secondary drying. Specifically, it provides up-to-date recommendations for selecting freeze-drying conditions based on the physical-chemical properties of formulations and engineering considerations.

    This paper discusses fundamental factors to consider when selecting freezing, primary drying, and secondary drying conditions. It offers mathematical models to predict the duration of each segment and the product temperature during primary drying. Three simple heat/mass transfer primary drying (PD) models were tested, and they demonstrated good agreement in predicting product temperature and sublimation time. These PD models were validated based on experimental data and used to tabulate primary drying conditions for common pharmaceutical formulations, including amorphous and partially crystalline products. Examples of calculated drying cycles, encompassing all steps, are provided for typical amorphous and crystalline formulations.

    The authors revisited advice from a seminal paper by Tang and Pikal (Pharm Res. 21(2):191-200, 2004) on selecting freeze-drying process conditions and found that the majority of recommendations are still applicable today. Several advancements, including methods to promote ice nucleation and computer modeling for all steps of the freeze-drying process, have been made. The authors have created a database for primary drying and provided examples of complete freeze-drying cycle designs. This paper can supplement the knowledge of scientists and formulators and serve as a user-friendly tool for quickly estimating the design space.

    Thank you to the authors: Serguei Tchessalov (Pfizer), Vito Maglio (Purdue University), Petr Kazarin (Purdue University), Alina Alexeenko (Purdue University), Bakul Bhatnagar (Pfizer), Ekneet Sahni (Regeneron), and Evgenyi Shalaev (AbbVie) for your hard work and dedication to this project.

    Download the paper here:

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Purdue University researchers are using a unique approach to help make a significant impact on the global #vaccine supply chain. The Purdue-led team has been awarded nearly $1 million to pursue a technology using #microwaves to make the freeze-drying process for vaccines faster and more cost-effective. Merck and IMA Life North America partnered with #Purdue to carry out the project, funded by the National Insititute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). “This is yet another example of a Purdue innovation that can make an impact on the world,” said Purdue Innovates senior vice president Brooke Beier. “Purdue Innovates is focused on results: transforming research into intellectual property that can be licensed to startups and industries and, finally, products that can save lives.” Read more:

Purdue’s microwave technology could lead to more stable vaccine supply chain

Purdue’s microwave technology could lead to more stable vaccine supply chain

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