We built our facility at the Innovation Park in Stirling, Scotland in 2011 with technical capability, quality assurance and operational flexibility at its core. Its design gives you quick access to production slots to progress batch release in less time, without any compromise on quality.
To save you invaluable development time, our MHRA-licensed facility was designed to ensure lead times that the global drug development market needs in order to deliver key milestones and clinical trial deadlines are met.
Fully compliant with GMP regulations, our facility allows us to fill a range of products for clients including monoclonal antibodies (mAbs), proteins, peptides, Ribonucleic Acid (RNA), cytotoxic, cytostatic and high potent APIs including antibody drug conjugates (ADCs).
A Technical Innovation
- Our filling cabinets are fitted with RABS (Restricted Access Barriers) technology, providing enhanced sterility.
- Remote digital cameras provide off-site clients with the ability to monitor and view the manufacturing process of their products at the critical stages of the process.
- Electronic quality management system.
- We can manufacture bulk volumes <100 litres.
What does the Facility Offer?
- A 6,300 ft2 purpose-built sterile manufacturing facility
- Separate and dedicated areas for the receipt, quarantine and storage of in-coming materials
- Two purpose-built cleanroom suites
- Dedicated suite for handling cytotoxic/high potent APIs
- A lyophilizer in each suite with 5.4 m2 of shelf space
- In-house vial washing and depyrogenation capability
- Dedicated inspection and labelling facilities for handling conventional and high potency product
- Temperature controlled areas for the quarantine and storage of finished drug product prior to dispatch to the client
- Final product release testing to GMP requirements
- Ability to undertake in-process chemical, physical and microbiological testing at critical stages during the manufacturing process as require
- All filling, lyophilization, and crimping activities undertaken and maintained under continuous Grade A cGMP conditions in a Grade B background
- Continuous particle monitoring undertaken in all critical areas
- QP release of GMP products to clients and clinics where appropriate
- Project management from the moment we start working with you until your drug product is delivered and beyond
- All hazardous APIs handled in a filtered externally ducted containment cabinet to maximise operator protection and minimise bioburden during drug solution manufacturing
- All conventional biological APIs handled in a Grade B airflow cabinet to minimise bioburden of the manufactured formulation prior to sterilization by filtration
Take a look
Our facility was purpose-built to meet increasing market demand for small-scale, shorter sterile drug product development timelines, while consistently maintaining regulatory compliance. Watch the video above to take a look inside our facility.