Press release - 09 September 2011
The British Standards Institution (BSI) is assisting healthcare manufacturers get products to market with the launch of a new Publicly Available Specification (PAS) providing guidance on the development of human cells for clinical applications.
PAS 93:2011, Characterization of human cells for clinical applications – Guide - is designed to assist any organization or end user in this arena including: academic groups, small and medium sized enterprises (SMEs) and larger industrial manufacturers as well as the general public.
Many organizations are developing new treatments using human cells as their building blocks, including regenerative medicine products based on stem cells. The recommendations and guidance in PAS 93 will assist developers in understanding the importance of characterizing the behaviour of their cells, which in turn will help facilitate a comprehensive approach to quality of the cell therapy product.
Cells are very sensitive to their environment and can undergo extensive changes in behaviour in response to external stimuli. Using the framework described by PAS 93, developers of the products will better understand how the manufacturing process impacts upon the cells and how to confirm that the required cell functions and behaviour are maintained. The PAS also gives guidance on the available methods that can be used by developers to help inform the selection of appropriate cell characterization techniques.
Mike Low, Standards Director at BSI said: “PAS 93 provides a structured framework that will help guide developers of new cell therapy products towards successful commercialization and adoption of the technology. By partnering with experts in the field of regenerative medicine, this standard harnesses their knowledge and will help to guide organizations of all sizes to adopt industry best practice”
Low adds: “BSI is investing significant resources to support the UK innovation agenda and PAS 93 reaffirms our commitment to providing industry with standards that provide real societal benefits both economically and socially.”
For further information on PAS 93, Characterization of human cells for clinical applications – Guide - or to buy a hard copy or download the standard, visit http://shop.bsigroup.com/pas93