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Cleanroom facility

The cleanroom facility is licensed for GMP manufacture providing researchers with the ability to translate basic studies and pre-clinical work from the laboratory bench to clinical trials.

Cleanroom facility

The cleanroom facility provides researchers with the ability to translate their regenerative medicine research from basic studies and pre-clinical work, to clinical trials, by providing the capacity to generate clinical grade Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs). The facility is fully GMP compliant and licensed for the manufacture of IMPs, ATMPs and medical devices for clinical trials, or as specials.

The cleanroom facility is based in the Core Technology Facility and houses two high specification adjacent cleanrooms with individual processing and preparation/support areas and a quality control laboratory.

This is the first GMP facility in the North West to engage in the GMP derivation of human embryonic stem cell lines, which will allow researchers to develop stem cell products to standards suitable for human clinical trials and future potential therapeutic use. The cleanrooms can also be used for the GMP production of autologous and allogeneic cell therapies, gene therapies or novel biomaterial based medical devices for clinical trials.

Facility and capabilities

The cleanroom facility has a Quality Management System which meets the requirements for EU Good Manufacturing Practice (GMP) and the Human Application (HTA) sector; and a quality control laboratory for release and intermediate testing of manufactured products. Our facility provides controlled temperature storage which is continuously monitored for all critical equipment by a building management system which has internal and external alarms that alert mobile phones for any temperature excursions. We can store any incoming consumables and reagents or outgoing manufactured products at a range of different temperatures including:

  • Ambient (15 – 25 °C)
  • Refrigerated (2 to 8°C)
  • Frozen (-20°C)
  • Frozen (-80°C)
  • Frozen (liquid nitrogen vapour phase)

Cleanrooms

The facility houses two adjacent EU GMP Grade B cleanrooms which contain EU GMP Grade A Microbiological Safety Cabinets (MSCs). Each of these cleanrooms has their own preparation/support areas. All of these areas are environmentally monitored to EU GMP.

 

Cleanroom map

Equipment

  • Microbiological safety cabinets
  • IVF hood 
  • Centrifuges
  • Microscopes 
  • Refrigerators (2 – 8 °C)
  • Freezers (-20°C and -80°C)
  • Fume Hood
  • Incubators
  • CO2 Incubators 
  • Hypoxic Incubators
  • Liquid nitrogen freezers and dewars
  • Viable air Samplers 
  • Particle counters 
  • Plate readers
  • Particle counters
  • Controlled rate freezer
  • Continuous monitoring through a building management system
  • Rapid sterility testing using BacT/ALERT® 3D Signature

Translational services

As part of our translational services we assist researchers in the production of GMP documentation and support the incorporation of them into the Quality Management System. Examples of the types of documents we help with are:

  • Standard Operating Procedures (SOPs)
  • Batch Manufacturing Records (BMRs)
  • Protocols 
  • Reports 
  • Label production and reconciliation

We also provide support with regulatory documentation for GMP content, e.g. Clinical Trial Protocol, Investigational Medicinal Product Dossier (IMPD), Investigator’s Brochure (IB) and Technical Dossier for Medical Devices.

Current University of Manchester projects

Projects

  • Professor Giulio Cossu – Development of a cell/gene therapy treatment for Duchenne Muscular Dystrophy (ATMP)
  • Professor Susan Kimber – Human ESCs differentiated to chondrocytes, for repair of Osteoarthritis (GMP Allogeneic Cell Banks)
  • Dr Adam Reid and Professor Julie Gough – Translating Polynerve, a novel synthetic polymer nerve conduit for peripheral nerve regeneration (Medical Device)
  • Professor Brian Bigger – To establish the scale up for autologous hCD34+ cell transduction with appropriate release criteria for ATMP manufacture (iMATCH)

Commercial activity

  • Contract sterility testing and validation of sterility testing
  • Contracted provision of Quality Management System and environmental monitoring service
  • Contract manufacture of IMPs, ATMPs and Specials

Regulatory licences

The University of Manchester Cleanroom Facility holds the following licences:

  • Medicines and Healthcare Products Regulatory Agency (MHRA) Manufacturer’s Authorisation for Investigational Medicinal Products (MIA) IMP and Manufacturer's “Specials” (MS) Licences 
  • Human Tissue Authority (HTA) Human Application Licence 
  • Human Fertilisation and Embryology Authority (HFEA) Licence

Staff

The cleanroom comes under the academic leadership of Professor Susan Kimber, who is supported by the Production Manager, the Head of Quality, Qualified Person (QP), Research and Cleanroom Technicians, a Cleanroom Manufacturing and Validation Technician and a Quality Coordinator and Document Controller.

Training

All research staff working in the cleanroom facility at The University of Manchester perform GMP training, Gowning Qualification and Broth Validation/Environmental Monitoring training to allow them to work in the cleanroom. As part of technology transfer from the laboratory to GMP manufacture we also provide project specific training.

Cleanroom contact

Joan Benson, Production Manager

Tel: +44 (0)161 275 7436

Email: joan.benson@manchester.ac.uk

General enquiries

Email: FBMH.CleanRoom@manchester.ac.uk