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.