Spotlight

• 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: https://link.springer.com/article/10.1007/s11095-023-03607-9

LinkedIn

2023/8/25

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: https://ow.ly/mjku50PE5J7

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

purdue.edu

In the News

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

  Oct 03, 2023

  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…

• Purdue-Ireland relationship fosters research and study abroad opportunities in pharmaceutical manufacturing

  Oct 03, 2023

  A recent Purdue Today article, accessible here, highlights the synergy between Purdue's prominent expertise in pharmaceutical manufacturing research and education and Ireland's strong pharmaceutical manufacturing sector. The two entities are continually enhancing their collaborative research efforts and expanding study abroad opportunities. The article details the American Irish Medical Summit held in Dublin this August, which was attended by Purdue University representatives. Hosted by the Royal College of Surgeons in Ireland, AIMS serves as a consortium of academic, government, and industry leaders dedicated to advancing health technologies, fostering research and academic partnerships, and developing leadership within…

• LyoHUB demo facility project featured in recent news article

  Sep 14, 2023

  The article, featured in Purdue Today, describes a grant that was received to expand RF project ongoing in the LyoHUB demonstration facility. Dr. Alexeenko (Co-Director of LyoHUB), Drew Strongrich and other collaborators are…

• LyoHUB at 2023 Freeze Dry Conference in Breckenridge, Colorado

  Sep 05, 2023

  Summer 2023 brought together lyophilization experts and students to the 2023 Freeze Dry Conference in Breckenridge, Colorado.  LyoHUB was well represented at the conference, as not only an…

Events

• April 19, 2023: LyoHUB  Annual Meeting at the Big Ten Headquarters in Chicago, IL

  Registration is now open for the 2023 LyoHUB Annual Meeting LyoHUB Members, Please join us for the 2023 LyoHUB ANNUAL MEETING to be held at the Big Ten Center (5440 Park Pl, Rosemont, IL  in…

• April 14, 2023: AstraZeneca & LyoHUB host Inhaled Biologics Conference

  AstraZeneca and LyoHUB present “Inhaled Biologics: Challenges, Opportunities, and Future Directions”, a 1-day conference to highlight the progress made in the delivery of…

• September, 2022: LyoHUB holds Annual Meeting and Roadmapping Workshop at Purdue University

  In September, 2022 over 50 participants representing over 27 organizations gathered at Purdue University to hold our first Annual Meeting since the COVID pandemic began. We were honored to…

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