A new contract manufacturing facility at the University of Edinburgh has received Medicines and Healthcare products Regulatory Agency (MHRA) approval to import and manufacture Investigational Medicinal Products for use in human clinical trials.
The Good Manufacturing Practice (GMP) Facility within the Healthcare Technology Accelerator Facility (HTAF) now provides a faster, regulated route to take novel discoveries - including new formulations, and active pharmaceutical ingredients- through late-stage development and into early-stage clinical evaluation.
Available to researchers and commercial partners, a particular strength of the facility is its ability to conduct small batch manufacturing.
The HTAF consists of a warehouse, Active Pharmaceutical Ingredient (API) laboratory, QC laboratory and three segregated cleanrooms for the manufacturing of sterile and non-sterile drug products.
Each laboratory is overseen by highly qualified chemists and quality assurance staff with extensive experience of supporting academic and commercial partners with bespoke small batch GMP manufacturing services.
Aiming to expedite the development of healthcare technology, the HTAF is embedded within the University’s wider translational ecosystem, within the Institute for Regeneration and Repair (IRR), at Edinburgh BioQuarter.
Professor Kev Dhaliwal, HTAF Director and co-director of the Baillie Gifford Pandemic Science Hub said:
This MHRA milestone is the culmination of years of work building quality management systems, validated processes, and the team capability needed to manufacture clinical-grade products within an academic setting. It means we can move faster - learning earlier in humans whether an innovation is worth pursuing - and do so in a way that is rigorous, safe, and globally collaborative.
And by strengthening the links across related centres* such as the LifeArc Centre for Rare Respiratory Diseases, EPSRC MicroTex hub and the Baillie Gifford Pandemic Science Hub we aim to accelerate innovation in respiratory diseases, infection, inflammation, and pandemic-relevant therapeutic development, while supporting early phase experimental medicine approaches across organs and diseases.”
Dr Emma Duffy, HTAF manager, said:
The value of this facility is agility. When formulation development or manufacturing steps need to evolve, we can iterate without months of scheduling delay, while maintaining the regulatory standards required for clinical studies.”
A UK-wide centre bringing together patients, researchers, clinicians and industry partners to accelerate discovery, development and delivery of diagnostics and therapeutics for rare respiratory diseases.
A hub linking cutting-edge science with collaborative clinical practice to find, develop and test effective treatments at speed, and to strengthen infrastructure for outbreak and pandemic response and lung diseases.
An EPSRC research and partnership hub in microscale science and technology to accelerate therapeutic innovation, linking engineering, robotics, AI and clinical medicine, including experimental medicine and microdosing approaches.
A University of Edinburgh research institute at Edinburgh BioQuarter bringing together scientists and clinicians to advance human health through regeneration and repair, and to support translation of new therapies.
