Development and fundamentals of membrane processes

越来越多用于癌症诊断和治疗的候选治疗性蛋白质已经达到或接近商业化状态。这些治疗性蛋白质产品的提纯可占总制造成本的80%。需要替代的净化工艺，能够以负担得起的成本提供高纯度的产品，以便这些产品可以向所有加拿大人提供。这项研究计划的长期目标是开发选择性和成本效益高的纯化工艺，使制药业能够向加拿大民众提供高质量的治疗性蛋白质产品。具有高选择性和高通量的膜层析材料是一种很有前途的纯化工艺选择。这些材料可以对加工条件做出反应。通过对材料性质的广泛表征和将这些材料性质与治疗性蛋白质的特定特征相关联，将获得高效的膜层析纯化过程。我们的工作将超越传统的实验方法，纳入新的数学模型，以捕捉材料的动态性质。我们还将使用复杂的材料表征技术来获得提纯过程的微观和瞬时特征。替代纯化工艺的实际实施和测试将用有前景的治疗性蛋白质产品，如单抗。

An increasing number of therapeutic protein candidates for cancer diagnostics and treatments have reached or are near commercialization status. The purification of these therapeutic protein products can represent up to 80% of the total manufacturing costs. Alternative purification processes are needed that can deliver high purity products at affordable costs such that these products can be made available to the entire Canadian population. The long term objective of this research program is to develop selective and cost efficient purification processes that will enable the pharmaceutical industry to offer high quality therapeutic protein products to the Canadian population. Promising purification process alternatives consist of membrane chromatography materials which offer high selectivity and throughput. These materials can respond to processing conditions. Efficient membrane chromatography purification processes will be obtained by extensive characterization of the material properties and by correlating these material properties to the specific characteristics of the therapeutic proteins. Our work will extend beyond the traditional experimental approach by incorporating novel mathematical models that will capture the dynamic nature of the materials. We will also employ sophisticated material characterization techniques to obtain microscopic and transient characteristics of the purification process. Practical implementation and testing of the alternative purification processes will be obtained with promising therapeutic protein products such as monoclonal antibody.