Predictive Model for a Novel, Low Cost, Single-Use Bioreactor

点击翻译按钮获取中文摘要

The objective of the current project is to generate and optimize a predictive 3-D model for a single-use bioreactor, particularly Membio's cartridge configuration single-use bioreactor. Upstream manufacturing technologies that are scalable, reliable, and cost-effective are now in high demand in pharmaceutical industry as single-use bioreactors to produce biologics. While Membio has expertise designing and constructing single-use bioreactors, no model yet exists to efficiently predict the effect of making design or operational changes to their bioreactors. Successful completion of this project will allow Membio to improve the design and operation of their biological manufacturing platform and direct their ongoing internal R&D of new product lines. The success of the project will also help strengthen Canadian bio-economy around biopharmaceutical manufacturing by improving a manufacturing platform that will be sold by Membio to enable cost-effective R&D, clinical trials, and commercialization of biologics. To date, various modeling approaches have been unsuccessful in their ability to predict the effect of changes to Membio's single-use bioreactor due to the novel nature of its design and operation. A robust, accurate, and integrative model, able to successfully predict the effect of design and operational alterations, is needed to drive new developments in biologics manufacturing. This proposal seeks to develop a predictive 3-D model for Membio's single-use bioreactor technology, the forerunner of upstream manufacturing technologies for the production of biologics, through the most cost-effective approaches available.