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

当前项目的目标是生成和优化一次性生物反应器的预测3d模型，特别是Membio的盒式一次性生物反应器。目前，制药行业对可扩展、可靠且具有成本效益的上游制造技术有很高的需求，可以作为生产生物制剂的一次性生物反应器。虽然Membio在设计和建造一次性生物反应器方面具有专业知识，但目前还没有模型可以有效地预测对其生物反应器进行设计或操作更改的影响。该项目的成功完成将使Membio能够改进其生物制造平台的设计和操作，并指导其正在进行的新产品线的内部研发。该项目的成功还将通过改进Membio将出售的制造平台，帮助加强加拿大围绕生物制药制造的生物经济，从而实现具有成本效益的研发、临床试验和生物制剂的商业化。到目前为止，由于Membio的一次性生物反应器的设计和操作的新性，各种建模方法都无法预测其变化的影响。一个强大的、准确的、综合的模型，能够成功地预测设计和操作改变的影响，是推动生物制剂制造新发展所需要的。该提案旨在通过最具成本效益的方法，为Membio的一次性生物反应器技术（生物制剂生产上游制造技术的先驱）开发预测性3d模型。

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.