ISO/PWI 26832

Biotechnology — Bioprocessing — General requirements for one pot multi-enzymatic catalysis

Scope

This document specifies requirements and guidelines for the design, construction, optimization,
and process control of one-pot multi-enzyme catalytic systems, which covers the entire
development cycle, from pathway design and enzyme selection to material preparation, kinetic
matching, system optimization, performance evaluation, and data reporting.
This document provides a three-stage iterative optimization process, with a focus on dynamic
matching as a critical control strategy to address the inherent challenges in multi-enzyme
catalysis, including the compatibility of reaction conditions and the accumulation of
intermediates.
This document is applicable to researchers, process developers, and quality control units involved
in the application of multi-enzyme systems for the production such as chemicals, pharmaceuticals,
biological ingredients, health products.