Assuring the quality of stem cells for the scientific and clinical community
The UK Stem Cell Bank provides vital support at the early stages of translational development of stem cells from research to commercial and clinical applications. It was established to provide a repository of human embryonic, foetal and adult stem cell lines as part of the UK governance for the use of human embryos for research. Its role is to provide quality controlled stocks of these cells that researchers worldwide can rely on to facilitate high quality and standardised research.
It also prepares stocks of EUTCD-Grade cell lines for use as starting materials for the development of cellular therapies. In this article, Glyn Stacey, Director of the UKSCB talks about how the UKSCB can provide support to the regenerative medicine community in the development of quality and safe cell therapies.
An interview with Glyn Stacey, Director of the UK Stem Cell Bank (UKSCB)
Can you tell us about the UKSCB
The UK Stem Cell Bank was initiated in 2003 by two of the UK Research Councils (MRC and BBSRC). Its funding formed part of the UK Government response to a public consultation which supported well regulated research based on the use of human embryos to generate embryonic stem cell lines for use in research and therapy. With its expertise growing in other types of pluripotent stem cell lines, it has developed to become a significant component of the UK regenerative medicine community, providing support for the UK’s regulatory framework and assists those translating research developments into clinical applications.
Tell us about mission statement and objectives
The UKSCB works in partnership with academia, industry and the regulators to facilitate the development of safe and effective cell-based medicines. It aims to achieve this through advice and worldwide provision of quality human stem cell lines of embryonic, fetal and adult origin for research. The UKSCB will further qualify such stem cell lines to the European Tissue and Cells Directive (EUTCD) standards and make banks of those available to the regenerative medicine community for the development of cell therapies under European regulation.
Why is it so important
The UKSCB has developed within the National Institute for Biological Standards and Control (NIBSC) which carries out product batch release testing of vaccines and biotherapeutics for Europe and the World Health Organisation (WHO). NIBSC also manufactures WHO reference materials which are a key component in international standardisation of biological medicines. As a part of NIBSC and more recently a part of the Medicines and Healthcare Regulatory Agency (MHRA), the UKSCB provides unparalleled expertise in regulatory science and standardisation of cell therapies.
It has used its expertise in regulatory science and provided advice to the largely SME based regenerative medicine industry as well as to academia in translational research projects.
It has further offered its experience in stem cell culture to support a number of international collaborations in best practice and in particular leads the International Stem cell Banking Initiative.
Tell us more about the research you are involved with
The UKSCB engaged in a broad range of basic and translational research in regenerative medicine. It is currently involved in three large EC funded consortia developing stem cell based assays for the evaluation of toxicity (ESNATS, ToxBank, Scr&Tox). It maintains its contribution to the development of a freely accessible registry listing all available pluripotent stem cell lines, including characterisation data and use in research (hPSreg). It is also supporting companies in government funded research, to develop new cryopreservation and viability testing technologies. Internal research work is focused on the evaluation and qualification of new analytical methods, cell culture techniques and reagents. More information on its collaborations is held at UKSCB website.
The UKSCB is now focussing its work on new hESC lines derived specifically for clinical applications in a programme of banking and characterisation to provide a panel of intensively characterised cell banks available for development of cell therapies. It will also now be developing associated tools and reagents to quality as reference materials for development and control of pluripotent stem cell lines for research and cell therapy.
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