17 November 2006
An information guide to promote best practice among scientists, industry and researchers involved with stem cell and other cell-based therapies was published today by the British Standards Institution, commissioned by the Department of Trade and Industry (DTI).
The Publicly Available Specification (PAS) document, Guidance on codes of practice, standardised methods and regulation for cell-based therapeutics, deals with the use of cell-based therapeutics, from basic research to clinical application.
It provides information for each different stage of the research process and directs scientists and researchers to relevant standards, regulations, legislation and key industry sources.
Minister for Science and Innovation, Malcolm Wicks, said: “Cell-based therapeutics, which includes therapies produced using stem cells, is a rapidly developing area where UK expertise will benefit our economy if it can be successfully exploited. What’s even more exciting is the potential that this technology has to dramatically improve the health and quality of life of millions of people.
“This guide will serve as a starting point for scientists to be directed to details of information they need and the various legislation they must adhere to during the process of taking research from the lab to the patient. I hope it will help in translating their work into medical advances”
Mike Low, BSI Director of British Standards said: “The potential of stem cells for the treatment of a variety of diseases is well known. However this industry is still in its infancy. As the national standards body for the UK, BSI is in a unique position to be able to independently consult with all relevant experts within the sector and to consolidate and promote best practice, which will benefit the stem cell community as a whole and reinforce the UK’s international standing.”
The PAS is designed to assist industry and researchers to understand current regulations surrounding cell-based therapies including stem cells. The guide has been produced to define and capture the key stages in a product lifecycle, from cell/tissue procurement through to commercialisation and post-launch requirements.
It was produced in collaboration with key stakeholders across the UK including stem cell researchers, the biotech industry and regulators. PAS 83 explains which laws need to be adhered to as well as highlighting important guidance and standards pertinent to each stage of the research and development process.
It references both EU and American markets to ensure that there is clarity on relevant standards needed to help exploitation of this key technology in the UK.