Symbiosis Completes Successful MHRA Audit of New Sterile Fill/Finish Facility, Expanding Global Manufacturing Capacity

Stirling, Scotland, 30 April 2025: 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.

ENDS

About Symbiosis Pharmaceutical Services

Symbiosis Pharmaceutical Services (Symbiosis) is a world-class Contract Manufacturing Organisation (CMO) located in Stirling, UK, and is a specialist sterile GMP manufacturer of biopharmaceuticals for use in clinical trials and commercial sales globally. Symbiosis is MHRA-licensed and FDA-inspected and offers a range of services including the aseptic fill/finish of medicines into vials, analytical testing, QP release of product, inspection, labelling, packaging and GMP temperature-controlled storage and shipment of medicines.

The Symbiosis facilities in Stirling, Scotland, were designed for biologic and small molecule pharmaceutical production to support biotechnology and pharmaceutical companies worldwide requiring sterile injectable pharmaceutical products manufactured in short timeframes for clinical trial use and commercial supply.

Regulatory compliance, technical capability and operational flexibility are core to the Symbiosis value proposition along with direct access to a highly experienced team of life science experts. By adding value directly to the new drug development projects and the commercial manufacturing supply chain requirements of its clients, Symbiosis has demonstrated consistent annual growth and built long-term relationships with its client base globally.

For more information, visit www.symbiosis-pharma.com or follow us on LinkedIn.

Media Contact:
Rachael Heath
ramarketing
rachael@ramarketingpr.com
www.ramarketingpr.com