A Continuous and Controlled Pharmaceutical Freeze-Drying Technology for Unit Doses

Driven by growing needs in the biopharmaceutical market and regulatory pressure, a continuous and controlled freeze-drying technology for unit doses to preserve biopharmaceuticals has been developed. Such continuous process allows a more efficient, cheaper, greener and controllable manufacturing method compared to traditional batch production systems, offering competitive advantages and business opportunities.

Pharmaceutical freeze-drying (lyophilization) is a low-temperature drying process in which aqueous solutions of heat-labile biopharmaceuticals are converted into solids with sufficient stability for distribution and storage. Similar to all manufacturing processes of drug products (solids, semi-solids and liquids), conventional pharmaceutical freeze-drying is generally accomplished using batch processing that is considered time-consuming, costly, non-flexible and lacking robust quality control and real-time release.

Four major industrial drivers are demanding a more efficient and better controllable pharmaceutical freeze-drying technology for unit doses: cost-cutting, regulatory pressure, a fast growing biopharmaceutical market and an ageing population requiring more personalized medicines.

The continuous and controlled freeze-drying technology, developed following the principle of model based design, offers clear advantages over current batch production such as cost reduction (up to 50%), track-and-trace product quality control, and a significant reduction of processing time (> 40 times faster, e.g. 1 hour instead of 5 days at a vial level), reduced need for clean room and a substantial sustainability gain.

Authors

Thomas De Beer (1,2)
Jos Corver (1)

Organisations

RheaVita, Ghent, Belgium (1)
Ghent University, Faculty of Pharmaceutical Sciences, Ghent, Belgium (2)

Presenting author

Thomas De Beer, co-founder - CTO, RheaVita
thomas.debeer@rheavita.com
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