Centrifugal Precipitation Chromatography for Biotechnology

描述（由申请人提供）：尽管细胞培养技术在从大体积发酵中以高产率生产蛋白质和生物制剂方面取得了很大进展，但由于纯化过程中缺乏高通量，因此在工业中存在瓶颈。离心沉淀色谱法是美国国立卫生研究院发明的一种新方法，由CC Biotech LLC授权，提供了纯化大分子的独特能力。在盐或溶剂的梯度中，在离心力的帮助下，大分子的离散分级是可能的。这种方法非常适合于蛋白质，DNA和许多生物聚合物。在流通式离心机中，当蛋白质被洗脱剂沉淀时，蛋白质被过滤膜保持。沉淀和再溶解的过程重复多次，导致组分在该过程中以不同的速率彼此分离。可以为许多类型的分子创建特殊的洗脱条件。该项目旨在为研究实验室市场制造仪器，以便其使用将开发新的纯化方法，以简化生物技术产品的工艺，此外，还将开发工业放大的参数。 公共卫生相关性：离心沉淀色谱法是一种新型的分离纯化技术，特别适用于生物大分子。作为这项研究的结果，新的治疗性生物制剂的纯化过程将得到简化，成本降低，为医疗保健提供非常纯的药物和疫苗。新的制造技术将被应用于制造一种改进的仪器，以推向市场。

DESCRIPTION (provided by applicant): Despite great progress in cell culture technology to produce proteins and biologics in high yields from large volume fermentations, there is a bottleneck in the industry because of the lack of high throughput in the purification process. Centrifugal precipitation chromatography, a new method invented at the National Institutes of Health and licensed by CC Biotech LLC, offers unique capabilities for the purification of large molecules. In gradients of salt or solvents, discrete fractionation of large molecules is possible, aided by centrifugal forces. This method is well adapted to proteins, DNA and many bio-polymers. In a flow-through centrifuge, proteins are held by a filtration membrane as they are precipitated by the eluting agents. The process of precipitation and re-dissolving is repeated many times, causing the components to separate from each other at their different rates in the process. Special eluting conditions can be created for many types of molecules. This project is aimed at manufacturing the instrument for the research laboratory market such that its use will develop novel purification methods to simplify the process for biotechnology products and additionally, develop parameters for scaling up in the industry. PUBLIC HEALTH RELEVANCE: A new technique of purification is centrifugal precipitation chromatography which is especially suitable for the large bio-molecules. As a result of this research, purification processes for new therapeutic biologics will be simplified, and the costs lowered, to provide very pure drugs and vaccines for healthcare. New manufacturing techniques will be applied to make an improved instrument for introduction on the market.