The recent increase in the number of orphan and rare drugs creates greater focus on personalized medicine and targeted therapies. These trends strongly suggest that batch sizes for sterile injectable drugs are decreasing. In addition, the market is experiencing an increase in demand for prefilled syringes.
To address these needs, Thermo Fisher has further invested in small-scale pre-filled syringe and vial filling capabilities within its Patheon global CDMO network, adding the Bosch FXS Combi Compact line to its Monza, Italy site. The line enables low-volume production for both clinical trial materials and commercial product while preserving valuable product with low material loss. The broad container range provides flexible options for clients and meets current expectations for regulatory and quality compliance for sterility. The company anticipates commercial production will begin on the line at the end of Q2 2018.