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AMERICAN FILTRATION AND SEPARATIONS SOCIETYTECHNICAL CONFERENCE

机译:美国过滤与分离学会技术会议

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摘要

The biotechnology industry has evolved as a revolutionary process with the potential ofrndramatically improving the overall quality of life, spanning health care, agriculturalrnproducts and industrial chemicals. However along with this potential is the enormousrnpressure to develop efficient, cost-effective products that achieve the goals asrnpromised.rnCross-flow membrane filtration offers tremendous opportunities to the biotechnologyrnindustry in being able to accomplish very distinct separations and purifications, resultingrnin significant advancements in both product development and quality.rnThe unique advantages that membrane technology offers are in its ability to achievernspecific fractionations of high value products in applications such as cell harvesting,rnprotein isolation and concentration and drug purification. In many cases, the results arernextremely high purity of these products at much higher yields and lower operating costsrnthan traditional separation methods such as centrifugation, rotary vacuum filters andrnfilter presses.rnThe effective design of the membrane system itself is a critical factor to enable thernprocessor to take full advantage of these potential benefits. This presentation willrnaddress the more prominent considerations that are used in the design of thernmembrane plant.rnThe design of the membrane system will greatly depend on the specific properties of thernultimate product being harvested or processed. The key properties of the products thatrnimpact the system design are:Stability of the productrnShear sensitivityrnVolume of product to be processedrnUpstream and downstream operation steps Taking these factors into consideration, the steps in the design process will thenrninclude:Review of System Design Criteria, such as:GMP compliancern3A sanitary standardsrnSpecific requirements, I.e. Explosion Proof Pilot Testing Compiling and review of datarnScale Up
机译:生物技术产业已经发展成为一个革命性的过程,具有极大地改善人们的整体生活质量的潜力,涉及医疗保健,农产品和工业化学品。然而,伴随着这种潜力的是巨大的压力,需要开发出能够实现既定目标的高效,具有成本效益的产品。错流膜过滤为生物技术行业提供了巨大的机会,使其能够完成截然不同的分离和纯化,从而导致两种产品的重大进步膜技术的独特优势在于能够在诸如细胞收获,蛋白质分离和浓缩以及药物纯化等应用中实现高价值产品的特定分级分离。在许多情况下,与传统的分离方法(例如离心,旋转真空过滤器和压滤机)相比,结果是这些产品的纯度极高,产率高得多,运行成本也低。膜系统本身的有效设计是使处理器能够采用的关键因素。这些潜在利益的全部优势。该演讲将解决在膜工厂设计中使用的更为突出的考虑。膜系统的设计将在很大程度上取决于要收获或加工的最终产品的特殊性能。影响系统设计的产品的关键特性包括:产品的稳定性-剪切敏感性-要处理的产品的数量-上游和下游操作步骤考虑到这些因素,设计过程中的步骤将包括:审查系统设计标准,例如: GMP符合性3A卫生标准特殊要求,即防爆试验测试数据的汇编和审查

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