PAS 83

Responding to government aims to make the UK a global leader in the translation of stem cell science into therapeutic and biomedical research applications, the DTI has commissioned BSI to develop a document that will map and inform industry and researchers of the critical path requirements, from research to clinical trial within the UK.

The project will cover all cell-based therapies and will reference both EU and US markets. The output will be published in Autumn 2006 as a Publicly Available Specification (PAS) with the draft title PAS 83 Guidance on standards, standardised methods and regulation for cell-based therapeutics, from basic research to clinical application.

As with all emerging technologies, there is a proliferation of standards, legislation and regulations which is leading to confusion over best practice and provenance. PAS 83 aims to provide a platform which will guide and inform industry of the standards and documentation necessary for the development of cell derived products. This will help ensure that any lack of clarity on relevant standards does not act as an obstacle to exploitation of this key technology.

Benefits of PAS 83:

• Flexibility for innovation
  The PAS will offer valuable support to researchers undertaking development projects and encourage a flexible and innovative approach.
• Clarity of approach
  As researchers approach early phase clinical trials, they have realised that the proliferation of standards, guidance documents and codes of practice is leading to confusion over best practice and provenance. Guidance is therefore needed on standards applying to the development of stem cell derived products. PAS 83 will cover areas such as characterisation, culture and storage, and how these are integrated into the regulatory framework. This will help ensure that any lack of clarity on relevant standards does not act as an obstacle to exploitation of this key technology in the UK.
• Open standard
  The development of PAS 83 is funded by the DTI. The content however will be developed by consensus with industry, ensuring all views are considered. This will result in a document that is a valuable tool for those researching and developing therapies.

"THE HARD CELL", article published in Business Standards magazine (February 2007) [PDF 151kb].

Get involved

BSI Professional Services will impartially faciliate this project and encourages all relevant parties to contribute to the final guidance document ensuring all views are considered, resulting in a document that is a valuable tool for those developing therapies.

If you would like to get involved in this project, please contact us at value@bsigroup.com or call +44 (0)20 8996 7090.

Download the Guidance for cell-based therapeutics PDF brochure (file size 57kb).