PAS 93:2011 Characterization of human cells for clinical applications. Guide
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What is it?
Publicly Available Specification (PAS) 93 is a best practice guide for organisations that develop products for clinical applications, using human cells as their building blocks, including regenerative products based on stem cells.
It can help organisations to get products to market. Many organisations 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 them take a comprehensive approach to the quality of the cell therapy product.
PAS 93 was commissioned by the Department for Business Innovation & Skills (BIS), with input from the following organizations:
BioPharmaceutical Solutions Ltd, Department for Business Innovation & Skills (BIS) - Office for Life Sciences, Cell Data Services, Consulting on Advanced Biologicals, Department of Health, LGC, Loughborough University - Centre for Biological Engineering, National Physical Laboratory, University College London and University of Sheffield - Centre for Stem Cell Biology.
How does it work?
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 have a clearer understanding of how the manufacturing process impacts upon the cells and how to confirm that the required cell functions and behaviour are maintained.
PAS 93 covers the need for the characterization of cellular starting materials and cellular active substances and the characterization parameters (including identity, purity, cellular impurities, biological activity and viability).
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.
Who should buy it?
- Medical and healthcare manufacturers of any size
- Developers of new cell therapy products
- Academic groups
- Anyone using cell-based products
What’s in PAS 93? Contents include:
- Ministerial statement
- Terms, definitions and abbreviated terms
- The need for characterization
- Scientific need for characterization
- Regulatory need for characterization
- Provenance of the cells
- Characterization of cells
- Biological activity
- Cell characterization techniques
- Overview of PAS 93 scope
- Application of cell characterization techniques – Constituent analysis
- Application of cell characterization techniques – Whole cell analysis
- Practical considerations for cell characterization techniques – Constituent analysis
- Practical considerations for cell characterization techniques – Whole cell analysis
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PAS 93 is available for free download.
What is a PAS?
A Publicly Available Specification (PAS) is a sponsored fast track standard driven by the needs of the client organisations and developed according to guidelines set out by BSI. Key stakeholders are brought together to collaboratively produce a BSI-endorsed PAS that has all the functionality of a British Standard for the purposes of creating management systems, product benchmarks and codes of practice.
In not more than two years from the date of publication a PAS is reviewed to determine whether amendment or revision is required or whether it should be considered for conversion to a formal British Standard.
A wide range of PAS documents are available to buy in the BSI Shop, many as instant downloads. Some are available free.
More details about fast-track standards, how PASs are commissioned, and how they could help your business visit BSI's Standards Solutions area.
Feedback on the technical content of PAS 93 can be submitted through the BSI Document Feedback system, http://feedback.bsigroup.com/Home/Details/850, throughout the first two years of its publication.
Any feedback received will be reviewed when developing future revisions of this document.