A decisional-support tool to model the impact of regulatory compliance activities in the biomanufacturing industry

Abstract

This paper discusses the need for decisional-support tools in the biotech industry and presents the configuration of a prototype tool for modelling bioprocesses and regulatory compliance activities such as quality control (QC), quality assurance (QA) and batch documentation in a biopharmaceutical plant. The impact of employing a range of manufacturing options on financial and technical performance was used to evaluate the functionalities of the tool. In a case study investigating pooling strategies in mammalian perfusion culture, the modelling tool provides indications as to the feasibility of different manufacturing options and ultimately is an aid in the decision-making process. The tool enables the effect of regulatory compliance activities on operational costs and demands on resources to be evaluated. The study demonstrates the use of such a software tool for the facilitation of early planning of process development and the appropriate allocation of resources.