Symbiosis Pharmaceutical Services (Symbiosis), a global sterile fill/finish contract manufacturing organisation (CMO) has successfully completed its latest audit by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), following an inspection of its new GMP manufacturing facility.
The inspection assessed the company’s 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 Symbiosis’ £26 million strategic investment to scale its 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, the new facility now integrates advanced fill/finish technology with Symbiosis adding to its current capabilities including GMP QC laboratories and aseptic processing suites, enabling the company 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 its founding in 2011. This regulatory endorsement reinforces Symbiosis’ commitment to global quality standards and strengthens its 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 Symbiosis’ 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
With over 14 years of regulatory success within the global marketplace, Symbiosis combines technical expertise, responsive project management, and regulatory excellence to support the production of complex sterile injectables.