GMP Compliant Manufacture
GMP cell product production facility
The University of Manchester 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; these include celltherapy and novel biomaterial based products.
The Cleanroom Facility is based in The University of Manchester’s Core Technology Facility, and houses two adjacent Cleanrooms with individual processing and preparation/support areas and a quality control laboratory. The University of Manchester Cleanroom Facility 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 or novel biomaterial based medical devices for clinical trials.
The University of Manchester Cleanroom Facility hou ses a fully equipped GMP laboratory for release and intermediate testing and environmental monitoring.
Current Cleanroom Facility Projects:
- Giulio Cossu – Development of a cell/gene therapy treatment for Duchenne Muscular Dystrophy.
- Susan Kimber– Human ESCs differentiated to Chondrocytes, for repair of Osteoarthritis.
- Adam Reid and Julie Gough– Translating a novel synthetic polymer nerve conduit for peripheral nerve regeneration.
The production facility at The University of Manchester Cleanroom Facility is capable of conducting the following operations:
- Production and storage of cell banks.
- Aseptic cell culture.
- Aseptic preparation of media, supplements and other intermediate products.
- Aseptic preparation of finished product forms, IMPs, ATMPs or Specials, according to the authorisation of the appropriate MHRA licences.
- Primary packaging.
- Secondary and tertiary packaging (labelling, cartoning and thermally controlled tertiary packaging).
- GMP testing of final products and intermediates.
- MHRA: Manufacturing Authorisation for Investigational Medicinal Products and Specials Manufacturing MIA
(IMP) Licence; Authorisation Number: MIA (IMP) 35030; Site Number: 2459992. The MHRA licence also authorises Quality Control Testing supporting release of IMPs.
- HTA: Processing, distribution and storage of tissues and/or cells intended for Human Use. Licence number: 22627.
- HFEA: Collection and donation of embryos for research and storage, including Derivation of Human Embryonic Stem Cell Lines. Licence numbers: R0171-2-b.
- Senior Management: Professor Sue Kimber
- Head of Quality: Dr Geoff Sharpe
- Head of Production: Joan Benson
- Qualified Persons: Geoff Sharpe and Julie Walker
The facility has support staff consisting of Cleanroom and Research Technicians, a Cleanroom Manufacturing and Validation Scientist and a Quality Coordinator and Document Controller.
Viable Air Samplers
Controlled Rate Freezer
Freezers -20°C and -80°C
Incubators and CO2 Incubators
Microbiological Safety Cabinets
Liquid Nitrogen Freezers and Dewars
Continuous Monitoring via Building Management System
Rapid Sterility Testing using BacT/ALERT® 3D SignatureEndotoxin Testing using Cambrex ELx808 and WinKQCL Software