Workforce Development

There is a need for improved education and training in the science and technology of pharmaceutical freeze-drying in light of the increasing importance of new therapeutic and diagnostic agents that are freeze-dried.  Stakeholders include academics, industry, and government.  Freeze-drying is a highly specialized subject that is also broad-based; that is, deep expertise requires knowledge of physical chemistry, flow properties of gases in the rarified regime, principles of process dynamics and control, and other subjects.  No one university curriculum would be expected to cover all of these topics, so a focused effort is needed to provide the necessary scientific and technical background.  The need is underscored by both the inefficiency of conventional freeze drying and the high cost of most new biotechnology-derived therapeutic agents.  The current state of education and training in pharmaceutical freeze-drying can probably best be described as isolated efforts with no broad consensus as to subject areas of emphasis.  Industry and government, in particular, would benefit by a broad-based effort drawing on the collective expertise of subject matter experts across industry, regulatory agencies, and academic institutions.

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Pharmaceutical freeze drying is a highly interdisciplinary field that encompasses physical chemistry, transport properties of gases under rarified conditions, principles of process dynamics and control, process modeling, materials characterization, and other subjects.  No one university curriculum could be expected to adequately cover all of these topics.  Given the importance of freeze-drying as a unit operation in the manufacture of a continually growing number of new therapeutic and diagnostic agents, there is a need for educational and training resources for industrial, academic, and government personnel in the science and technology of freeze-drying.

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The preparation of new modalities at the point of care may require knowledge of aseptic practices, drug administration, and cGMP / GDP. Develop a work force (BSPS) that provide training to handle these new complex medicines.

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This need is underscored by both the inefficiency of conventional freeze-drying and by the high cost of goods of most biotechnology-derived therapeutic agents.  The current state of education and training is perhaps best described as isolated efforts with no broad consensus as to what would constitute a core curriculum.  Stakeholders would benefit from a broad-based effort drawing on the collective expertise of subject matter experts across industry, government, and academic institutions.

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LyoHUB is well positioned to offer the necessary education and training.  Examples of resources either currently available, in development, or under consideration include:

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• Lyo Summer School – a 2-3 day short course in the fundamentals of pharmaceutical freeze drying, including laboratory demonstrations in thermal analysis, freeze dry microscopy, and analysis of process data, and process modeling.

• On-Line Course in Principles and Practice of Freeze-Drying – This course is primarily intended for working professionals with job responsibilities that involve freeze-drying, and whose job effectiveness would benefit by becoming more knowledgeable in the subject matter.  Development of this course is nearing completion, and is expected to be available in 2024.  There is the potential to develop this into a certificate program.