During the PharmSci 360 conference of 2023, an innovative continuous and controlled freeze-drying technology was presented. The concepts used in the continuous freeze drying design lift pharmaceutical lyophilization from a more than 80-year-old technology to the age of Industry 4.0. The novel approaches of fast spin freezing using sterile nitrogen gas flow, followed by radiative drying, deliver fast cycle times of less than 2 hours, as well as tightly PAT-based controlled processes delivering consistent quality. The coordinated intelligent systems that control output and ensure high product quality, increase the efficiency and sustainability at the commercial scale as well.
In this presentation, the GMP-production readiness of the technology will be discussed, including CIP/SIP, tracking and tracing of individual products, following guidelines regarding construction principles and materials, calibration and verification. Herewith, the applicability of the continuous freeze-drying technology to different formats (e.g., vials, DCCs, prefilled syringes) and different formulations (proteins, cell based therapies and mRNA-LNP based formulations) will be presented by means of case studies. Also the fast transferability from R&D to pilot and GMP production scale will be outlined. The R&D continuous freeze-drying Single Vial Unit is specifically designed for very fast formulation and process development with very limited material consumption. The resulting optimized formulation and process conditions can be directly transferred to the pilot and GMP-scale continuous freeze-dryers based on the real-time monitoring and active control systems in the technology, at the vial level.
Continuous freeze drying offers the opportunity to segment throughput capacity, providing a flexible facility able to react quickly to demand variations. The use of more energy sparing methods for freezing and drying significantly reduces the energy consumption of the unit operation. Small footprint continuous lines have fast change-over times, through built-in cleaning and sterilization systems. To conclude, several production scenarios will be presented.
We suggest integrating this talk in a broader symposium on innovative freeze-drying technologies by combining it with Coriolis Pharma's submission on “Developing Robust Lyophilization processes for biopharmaceuticals through process understanding”.
Learning Objectives:
Participants will be able to describe the innovative aspects of continuous and controlled freeze-drying technology, and articulate its benefits over traditional lyophilization methods in terms of efficiency, sustainability, product quality.
Participants will be able to identify the key components that make the continuous freeze-drying technology GMP-ready, including critical process analytical technology controls, cleaning-in-place/sterilization-in-place protocols, and product tracking and tracing mechanisms
Participants will be able to apply knowledge of continuous freeze-drying technology to various pharmaceutical formats (e.g., vials, dual chamber cartridges, prefilled syringes) and formulations, recognizing the technology's versatility and adaptability.
