Symbiosis is delighted to announce the successful completion of the latest audit by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), following an inspection of our new GMP manufacturing facility.
The inspection assessed our new purpose-built Bruce Building, a 20,000 sq ft aseptic facility housing an automated fill/finish line for the sterile manufacture of injectable drug products including small molecule and biologics. This successful audit marks another step in a £26 million strategic investment to scale our commercial manufacturing capabilities at a time when the biopharmaceutical industry is seeing record demand for specialist aseptic manufacturing capacity, particularly across advanced therapies and injectable biologics.
Formally opened by Scotland’s Deputy First Minister Kate Forbes in late 2024, our new facility now integrates advanced fill/finish technology and adds GMP QC laboratories and aseptic processing suites to our current capabilities, enabling us to support clients from clinical trials through to commercial manufacture with greater flexibility and speed.
Symbiosis’ strong regulatory track record continues to grow, having successfully passed multiple regulatory inspections by both the MHRA and FDA since the company was founded in 2011. This regulatory endorsement reinforces our commitment to global quality standards and strengthens our position as a trusted partner to biotechnology and pharmaceutical companies worldwide.
“This extension of our current MHRA licenses reflects the strength of our team and the robustness of our quality systems. For our clients, this solidifies confidence in our ability to accelerate the delivery of their sterile drug products to patients worldwide within a tightly regulated landscape.” said Colin MacKay, CEO of Symbiosis.
The expanded GMP facility enhances our ability to deliver:
- Aseptic fill/finish of liquid parenteral drug products
- Handling of cytotoxic and high-potency compounds
- Scalable batch sizes from preclinical to commercial
