Most recent
DS/ISO 24190:2023
Biotechnology - Analytical methods - Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
This document provides guidance, a framework and a risk-based approach for the selection and validation of methods for rapid microbial detection in cellular therapeutic product manufacturing.*This document provides a flexible risk-based framework for the detection of microbial contamination in cellular therapeutic products and cellular intermediates.*This document provides general requirements and risks associated with cellular therapeutic product manufacturing, with flexibility to address differences in specific manufacturing processes of each unique cellular therapeutic product.*This document primarily addresses sterility testing in cellular therapeutic product manufacturing. This document is applicable to other cell-derived therapeutic product manufacturing.*This document focuses on rapid microbial test methods (RMTMs) used for both in-process and final product testing.*Viral testing in cellular therapeutic product manufacturing is not included in this document.
Danish Standards [ds]