Symbiosis qualifies Flexicon automated fill-finish line in Scotland

Symbiosis, a sterile manufacturing contract development and manufacturing organization, said it has completed qualification of a new FPD 50 Flexicon automated fill-finish line at its commercial production facility in Stirling, Scotland.

The fully integrated system operates under a Grade A Restricted Access Barrier System (RABS) and incorporates rapid transfer ports for aseptic handling, high-accuracy vial filling with Flexicon pump technology, and a rotary crimp mechanism for consistent overseal application. The company said the system is designed to increase efficiency and maintain high regulatory standards.

“The qualification of our automated fill-finish line is a major step forward for Symbiosis. It enhances our technical capabilities and expands our capacity at a time when demand for high-quality sterile manufacturing continues to grow,” CEO Colin MacKay said in a statement.

Commercial production at the new facility is scheduled to begin in the fourth quarter of 2025 with batch sizes of up to 15,000 vials. The milestone follows the company’s 1,000th sterile batch produced in July and recognition earlier this year with the U.K.’s 2025 King’s Award for Enterprise in International Trade.

Symbiosis said it has maintained a track record of successful inspections by the U.S. Food and Drug Administration and the U.K. Medicines and Healthcare products Regulatory Agency since its founding. The company also supported the clinical development of the Oxford University/AstraZeneca COVID-19 vaccine and continues to manufacture sterile injectable products for a range of modalities and therapeutic areas.