Manufacturing and Bioprocessing – Biomolecular
2019 PharmSci 360
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 at unit dose level, 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. For freeze-drying unique PAT opportunities for control will be demonstrated.