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%), 100% track-and-trace product quality monitoring & 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. Feasibility studies and results using continuous freeze-drying prototypes will be shown.

Thomas De Beer, UGent

Prof. Thomas De Beer graduated in pharmaceutical sciences in 2002 at the Ghent University in Belgium. He obtained his PhD at the same university in 2007. For his PhD research, he worked three months at University of Copenhagen in Denmark (Prof. J. Rantanen). After his PhD, he was a FWO funded post-doctoral fellow at the Ghent University (2007-2010). Within his post-doc mandate, he worked 8 months at the Ludwig-Maximilians-University in Munich, Germany (prof. Winter and prof. Friess). In February 2010, he became professor in Process Analytical Technology at the Faculty of Pharmaceutical Sciences of the Ghent University. His research goals include the implementation of PAT systems in innovative pharmaceutical production processes.