Development Programme:
July to December 2004

Facilities and Quality Assurance

The potential uses to which both research and clinical grade stem cell lines maybe put in the future have necessitated a rigorous and diverse quality system. This involves elements from a number of international standards as well as GMP and has been designed to comply with the DH Code of Practice for Tissue Banks and the Steering Committee’s Code of Practice for the UKSCB and the Code of Practice for The Use of Stem Cell Lines. As well as complying with these Codes of Practice, the system incorporates NIBSC procedures will comply with ISO 17025 (Governing testing procedures) and ISO 13485 (for in vitro diagnostics). Additionally many management activities are modelled on the requirements for ISO 9000:2000. The quality system is a hierarchical system of linked documents covering all aspects of the Bank’s activities from supplier agreements through cell processing, safety testing, characterisation and quality control to the release of cells for issue. It also links to validation documentation to provide elements on operation, maintenance and training in the use of the validated equipment. During preparation of the Bank for inspection, over 350 separate documents (Component Specifications, Standard Operating Procedures, Forms, etc) have been written in addition to a comprehensive Quality Manual which details the overall strategy delivering compliance with the Codes of Practice.

The NIBSC has performed batch release testing of biological medicines (vaccine, blood products etc. for decades. The quality systems under which this work is accredited (ISO 17025) has been used as the basis for the UKSCB Quality System.

Scientific and Technical Developments

During summer 2004 the Bank prepared for a new and exciting international stem cell project initiated by the MRC. This project now named the International Stem Cell Initiative is intended to characterise all of the available ES cell lines now available around the world in order to identify the salient features of ES cell lines and the degree of diversity that different lines may exhibit. More than 15 expert stem cell research groups are now engaged in the project from the UK, USA, Canada, Japan, Australia, Israel, Czech Republic, Sweden and Finland. These centres will be characterising around 78 different ES cell lines most of which have been established since 2000. The Bank has prepared and distributed a reference cell line and reference MAbs for participant laboratories for use in the study. Following a standardised culture protocol samples from local unique cell lines will be provided by each centre, encoded at the UK Stem Cell Bank at NIBSC and forwarded to expert analytical labs for investigation of:

In addition prepared sections of tumours from pluripotency studies will be centrally compared by an expert histopathology lab and karyological data produced from each centre for their own cells will be collated

This project is unique in that it is based on a combination of some of the very best international expertise in embryonic stem cells and a world leader in biological standardisation the National Institute for Biological Standardisation and Control. Through the use of standardised methodologies, cell culture reagents and reference reagents such as reference antibodies and cells this is an opportunity to investigate all of the currently available ES cell lines as if they were being studied in a single World-Wide Laboratory. Further information on this project and updates on its progress should be available on the MRC web site (www.mrc.ac.uk).

One of the most important general activities for the bank is building appropriate scientific and technical expertise. In the first round of recruitment in 2003 the bank secured the expertise I the areas of cryopreservation, tissue banking, stem cell research and quality systems relating to the use of cell lines for batch release of biological medicines. In 2004 a further three members of staff have been recruited with experience in developmental biology, virology, cytogenetics and in vitro cell culture for provision of cell therapy. Thus the bank is developing a broad ranging expertise that will support its internal scientific development and its collaborations with the stem cell community.

Training

The Bank underwent its first internal audit in March prior to its inspection by the MHRA in April. This was carried out by the NIBSC quality department in conjunction with consultants from Jacobs Engineering and highlighted a number of areas which the Bank was able to address prior to the MHRA inspection. The MHRA inspection was carried out at the beginning of April 2004. No critical non-compliances were issued and the accreditation of the Bank under the DH Code of Practice appeared to have been successful, subject to a satisfactory response to the non-compliances (one Major and number of Minor) issued by the MHRA. These were addressed by the Bank in May in its response to the MHRA inspection letter and a certificate of accreditation was issued in Mid-June 2004.

Following its successful inspection, the Bank was officially opened on 19th May 2004 by Lord Warner, Undersecretary of State for Health. This coincided with the permission from the Steering Committee for the Bank to take in (Accession) the first two UK stem cell lines developed at King’s College, London and at the Centre for Life at Newcastle University. Over the next few months the Bank will be working closely with the depositors to translate the cells from the research environment into the Bank where they will undergo a comprehensive safety testing, cell characterisation and quality control regime prior to being made available to the scientific community.