Symbiosis Pharmaceutical Services Completes Successful FDA Inspection

• Symbiosis Pharmaceutical Services has passed its latest FDA inspection with zero GMP observations at its sterile manufacturing facilities in Scotland.

• The company is expanding its capabilities with a new automated sterile GMP manufacturing facility in Stirling, UK.

Symbiosis Pharmaceutical Services has successfully completed an inspection by the US Food and Drug Administration (FDA) at its sterile manufacturing facilities in Scotland. The seven-day inspection, conducted in January 2025, resulted in zero Good Manufacturing Practice (GMP) observations, reinforcing the company’s reputation for regulatory excellence and compliance.

Headquartered in Stirling, UK, Symbiosis specialises in the sterile manufacture of pharmaceuticals and biopharmaceuticals for clinical trials and commercial supply. The recent inspection focused on the fill/finish process of an adeno-associated virus (AAV) viral vector biologic for a long-standing US pharmaceutical client. The FDA’s findings validate the company’s robust quality management systems and commitment to regulatory standards.

Since its previous FDA inspections, Symbiosis has strengthened its regulatory framework by expanding its quality function, hiring experienced professionals, and enhancing process controls. These measures ensure the company maintains a state of regulatory readiness while meeting the growing demand for sterile GMP fill/finish services.

Colin MacKay, CEO of Symbiosis, commented: “Achieving this successful FDA inspection outcome is a reflection of our team’s expertise and ongoing commitment to quality excellence. In a rapidly evolving biopharmaceutical landscape, regulatory rigor and GMP operational performance are enduring priorities for the company and a fundamental part of our business and cultural ethos.”

Looking ahead, Symbiosis is advancing its operational capabilities with a new automated sterile GMP manufacturing facility near its existing site in Stirling. This expansion will enhance its commercial-scale manufacturing capacity, supporting global clients through clinical and commercial injectable drug production.