(594g) 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.