Symbiosis Secures MHRA Approval for New Aseptic Fill/Finish Facility

• Symbiosis has passed an MHRA inspection of its new 20,000 sq ft GMP manufacturing facility, part of a £26 million expansion.

• The site will support the aseptic fill/finish of sterile injectables, including biologics and high-potency compounds.

Symbiosis has successfully completed an inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA) of its newly built GMP manufacturing site, reinforcing its capabilities in aseptic drug production.

The regulatory inspection focused on the company’s Bruce Building, a 20,000 sq ft facility equipped with automated fill/finish systems for the sterile manufacture of injectable drugs, including both small molecules and biologics. The audit is a key milestone in a wider £26 million strategic investment aimed at scaling Symbiosis’ contract manufacturing operations.

Located in Scotland and formally opened by Deputy First Minister Kate Forbes in late 2024, the facility also includes GMP quality control laboratories and aseptic processing suites. These enhancements are intended to improve flexibility and turnaround time for clients requiring clinical and commercial manufacturing services.

The CDMO’s regulatory track record continues to grow, having undergone successful inspections by both the MHRA and the FDA since its founding in 2011. CEO Colin MacKay said, “This extension of our current MHRA licenses reflects the strength of our team and the robustness of our quality systems.”

The expanded facility allows Symbiosis to offer aseptic fill/finish, handle high-potency compounds, and support scalable batch sizes from early development through to commercial supply.