February, 2023 was raining with insightful input as 36 industry representatives, 6 academic institutions, and representatives from the National Institute of Standards and Technology (NIST), Federal Drug Administration (FDA) and National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) gathered online and at the National Academy of Science in Washington DC to develop roadmaps for the identified topics of 

• Lyophilization of New Product Modalities (e.g. mRNA LNP, Cell & Gene Therapies)
• Automation and Digitation for Lyophilization
• Freeze/Thaw Technologies
• Emerging Drying Technologies

In 2022, Purdue University received a second NIST award to:

1. update the lyophilization technology roadmap by addressing new product modalities such as mRNA vaccines, and cell and gene therapies
2. expand the roadmap to include alternative aseptic drying technologies such as spray drying, and
3. strengthen the industry-led consortium by creating infrastructure for roadmap implementation projects and workforce training on current and emerging technologies."

The goal of the Lyophilization and Aseptic Drying Technology Roadmap development is to identify drying/preservation technologies that are needed to advance the safety, quality and profitability of the U.S. pharmaceutical and life sciences industries. Here, “drying/preservation technologies” includes, but is not limited to:

• Improvements to existing lyophilization processes and products, or to supporting instruments, devices and computational models or analytical methods
• Innovative new lyophilization, drying, preservation processes and products, devices/products combinations or new supporting instruments, computational models or analytical methods focusing on aseptic manufacturing
• Educational, informational and workforce training materials and programs (incl. PhD and MS training)
• Identify projects and project areas that address these needs and could be funded by federal agencies, by LyoHUB, by industry or by other groups
• Identify the supporting infrastructure and collaborators needed to accomplish these projects (e.g., websites, pilot facilities)