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