What is this standard about?
PAS 83:2012 gives detailed guidance to increase clarity for users on the requirements needed for exploitation of cell therapy products in the European Union and the US.
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?
It provides the latest guidelines and recommendations surrounding requirements for the development of human cells for clinical applications. Organizations are developing new treatments using human cells and researching their behaviour – this PAS will give guidance on the level of regulation, guidance and associated quality issues that apply to cell therapy products.
The main focus of this PAS is cell based medicinal products (CBMPs) that are regulated as advanced therapy medicinal products (ATMP) in the EU and biologics (351 HCT/P) in the US. However, for completeness aspects of minimally manipulated, homologous use products (also known as 361 HCT/P in the US) are also covered.