BSI helps healthcare manufacturers bring regenerative medicinal products to market

Press release - 09 September 2011

The British Standards Institution (BSI) is assisting healthcare manufacturers to 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 behavior 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 behavior in response to external stimuli. Using the framework described by PAS 93, developers of the products will better understand how the manufacturing process impacts the cells and how to confirm that the required cell functions and behavior 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 practices”

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

About BSI

BSI (British Standards Institution) is a global organization that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Formed in 1901, BSI was the world’s first National Standards Body and a founding member of the International Organization for Standardization (ISO).

Over a century later it continues to facilitate business improvement across the globe by helping its clients drive performance, reduce risk and grow sustainably through the adoption of international management systems standards, many of which BSI originated. Famed for its marks of excellence including the instantly recognizable Kitemark®, BSI’s influence spans multiple sectors including aerospace, construction, energy, engineering, finance, healthcare, IT and retail. With over 70,000 clients in 150 countries, BSI is an organization whose standards inspire excellence across the globe.