What is this standard about?
PAS 93:2011 is a best practice guide for organizations that develop products for clinical applications, using human cells as their building blocks, including regenerative products based on stem cells.
Who is this standard for?
- Medical and healthcare manufacturers of any size
- Developers of new cell therapy products
- Academic groups
- Anyone using cell-based products
Why should you use this standard?
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 them take a comprehensive approach to the quality of the cell therapy product.
Using the framework described by PAS 93, product developers 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.
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