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Achieving continuous manufacturing in lyophilization: Technologies and approaches.

Roberto Pisano¹, Andrea Arsiccio¹, Luigi C Capozzi¹

¹Department of Applied Science and Technology, Politecnico di Torino, Torino 10129, Italy.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V

|June 29, 2019

Summary

This paper reviews continuous freeze-drying concepts, focusing on pharmaceutical applications. It offers a foundation for future research in continuous pharmaceutical manufacturing.

Keywords:

Continuous Drying Freeze-drying Freezing Manufacturing

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Area of Science:

Pharmaceutical Science
Chemical Engineering
Food Science

Background:

Continuous manufacturing is gaining traction in the pharmaceutical industry.
Freeze-drying (lyophilization) is a critical process for stabilizing sensitive pharmaceutical products.
Existing freeze-drying methods are often batch-based, posing scalability and efficiency challenges.

Purpose of the Study:

To provide a comprehensive overview of continuous freeze-drying concepts.
To highlight innovations and challenges in pharmaceutical freeze-drying.
To establish a basis for future research in continuous pharmaceutical manufacturing.

Main Methods:

Literature review of scientific publications and patents.
Analysis of various continuous freeze-drying technologies and approaches.
Comparative assessment of concepts for pharmaceutical applications.

Main Results:

Several continuous freeze-drying concepts have been explored, with varying degrees of development.
Key challenges include process control, product uniformity, and scalability.
The food industry offers some background and transferable concepts.

Conclusions:

Continuous freeze-drying holds significant promise for pharmaceutical manufacturing.
Further research and development are needed to overcome existing hurdles.
This review serves as a starting point for advancing continuous freeze-drying technologies.