Development Programme:
January to June 2003
The first task for the management team was assessing building options for the new GMP facility. This has not just been a paperwork exercise and numerous facilities have been visited to assess what can actually be achieved with the different building solutions available. The building work, laboratory fitting and laboratory procedures will benefit from substantial in-house NIBSC experience in clean-room operation and will also be independently assessed utilising external professional expertise in GMP. The specification for the new laboratory block was completed and sent out to tender early in 2003.
A modular prefabricated design was adopted and a contractor (Clean Modules Ltd) was appointed in February to undertake the construction of the GMP facility. To ensure that the facility complies with EU GMP and can be accredited under the DOH Code of Practice for Tissue banks a firm of validation specialists have been appointed as consultants to the project. Jacobs Engineering has a significant track record in validation of pharmaceutical operations and one of the consultants appointed to oversee the project was formally with the MHRA and a member of the working group that drew up and oversaw implementation of the DOH Code of Practice for Tissue Banks.
A detailed design was developed during the early months of 2003. The building comprises three modules that would be constructed off-site and transported to NIBSC for assembly in late summer 2003. Construction of the facility began off-site in March and the internal fitting out commenced in May with installation of the air handling, remote monitoring and electrical systems. In tandem with this process has run the specification, quotation and assessment process for the main items of equipment and orders for essential items were placed in June. Off-site construction is nearing completion and civil engineering work has commenced on-site with ground-breaking on 30th June.
The GMP facility will comprise a suite of cleanrooms comprised of three grade B laboratories, each connected to a grade C clean corridor by an airlock/change. The clean corridor connects to an outer corridor through two graded airlocks/change rooms. The outer corridor links the cleanrooms to associated office, storage and plant areas and the NIBSC main building. Within the grade B laboratories, the grade A air environment necessary to produce GMP compliant cell lines is maintained within Class II microbiological cabinets. Each laboratory is fully independent of the others and equipped with everything necessary to support cell banking operations.
The GMP facility will support the production of cell banks for therapeutic use. Cell lines for research will be supported by the Cell Biology Unit’s cleanrooms at NIBSC which themselves are being upgraded to improve the environment in which these cell banks will be produced.
The current programme, which includes completion of laboratory expansion to accommodate R&D cell lines and the construction of the new GMP laboratories, will be completed by December 2003. However, it is intended to initiate accession of cell lines for research as soon as practicable before this date.
The Head of the UK Stem Cell Bank, Dr Glyn Stacey has instituted a programme of visits to key stem cell research groups in the UK. Links have been established with many of these groups and others in Europe, the USA, Canada and Australia. Further lab visits are planned and it is intended to visit a cross-section of potential users to ensure that the operation of the UKSCB meets the needs of the majority of users. Feedback to the bank has also been established via the UK Stem Cell Bank Clinical and User Liaison Committees set up by the MRC.
In addition to these activities, the UK Stem Cell Bank communications group is establishing important communications materials. Regular newsletters will be the first output from the group and we intend to issue these updates on a monthly basis as the programme develops.
We are keen that the bank should be aware of the needs of potential users and the way in which the use community and the public view the bank. We therefore welcome input on the kind of information you would like to see presented in the bulletins and any other aspect of the work of the UK Stem Cell Bank.