PAS 157:2015 PDF

What is this PAS about? PAS 157 provides guidance to help developers of cell-based medicinal products improve the consistency and quality of the materials used in production with a view to eliminating/mitigating potential risks to product quality. Who is this PAS for?

Product developers at all stages but crucially at the early stages of development Organizations and individuals with an interest in the development of cell-based medicinal products

Why should you use this PAS? It offers recommendations and guidelines covering biological materials to be used in the production of cell-based medicinal products. This include gene therapies where the cells form part of the final drug product, such as ex-vivo transduced cells, but does not cover biological materials that are used in the development of any other medicinal product. This PAS also includes guidance on identifying, assessing and controlling risks to patients associated with materials of biological origin.

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