ISO/NP 25848

Biotechnology — Process monitoring in biomanufacturing — Vocabulary

Апстракт

This document defines terms related to process monitoring and process analytical technology in
biomanufacturing.
Terms include those related to manufacturing, process design, measurement, data analysis, process
control, and general concepts as they relate to process monitoring in biomanufacturing.
This document can apply to the manufacturing of cells and related entities, for example cells for
therapeutic use, organoids or microphysiological systems, and cells for drug discovery and testing.
This document also applies to cell-based material production applications such as monoclonal
antibody production processes.
NOTE Biomanufacturing does not imply a specific product sector, application area, production
scale, regulatory status, production platform, feedstock type or use of genetic modification.