Lim, AC; Zhou, YH; Washbrook, J; Titchener-Hooker, NJ; Farid, S; (2004) A decisional-support tool to model the impact of regulatory compliance activities in the biomanufacturing industry. COMPUTERS & CHEMICAL ENGINEERING , 28 (5) 727 - 735. 10.1016/j.compchemeng.2004.02.013.
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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. (C) 2004 Elsevier Ltd. All rights reserved.
|Title:||A decisional-support tool to model the impact of regulatory compliance activities in the biomanufacturing industry|
|Keywords:||simulation, modelling, process development, biotechnology, QC/QA|
|UCL classification:||UCL > School of BEAMS > Faculty of Engineering Science > Biochemical Engineering|
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