CENTRIFUGE/FILTRATION SYSTEM OR BIOPROCESS CLARIFICATION

描述（申请人的摘要）：本项目建议建立和验证一个 高效实验室规模离心机，配有一次性无菌内衬 将亚微米过滤器元件结合在离心机内， 用于澄清和灭菌细胞培养物的非常稳健的方法， 重组生物制药的生产。的效率和速度 已经预测了用于细胞和培养基的冷混合物的离心过程 使用流体动力学模型。使用5升实验室规模，以81 i/min的速度进行测试 设备可以达到10，000 g。所提出的装置和方法将 产生非常快速和彻底的产品纯化和澄清 负载的生长培养基。细胞溶解将由于相对速度而最小化。 该方法和低剪切和加热环境。这个过程非常 可以生产清洁的产品。实验室规模的测试与酵母，细菌和 哺乳动物细胞培养将由Dr.亚历山大Dilorio， 伍斯特理工学院的生物加工实验室， 新设备和新工艺的实用性。对比测试与 现有的过滤和离心方法将使用 建立了细胞和细胞碎片存在的测定方法， 细胞溶解的指标。 拟定商业应用： 申报器械和方法适用于澄清和灭菌需求 重组生物制药的实验室规模。 将有可能 放大装置以满足中试规模和生产需求。

DESCRIPTION (applicant's abstract): This project proposes to build and verify a highly efficient lab scale centrifuge with a sterile disposable liner incorporating a sub-micron filter element within the centrifuge to create a very robust method to clarify and sterilize cell cultures used in the manufacture of recombinant biopharmaceuticals. The efficiency and speed of the centrifugation process for a cold mix of cells and medium has been predicted using fluid dynamics modeling. Throughputs of 81i/min using a 5 liter lab scale device are attainable with 10,000 g's. The device and methods proposed will produce a very fast and thorough purification and clarification of product laden growth media. Cell lysis will be minimized due to the relative speed of the process and the low shear and heating environment. With this process very clean product may be produced. Lab Scale test with yeast, bacterial and mammalian cell cultures will be performed by Dr. Alexander Dilorio, Director of Bioprocessing Laboratory at Worcester Polytechnic Inst. to demonstrate the usefulness of the new equipment and process. Comparative testing versus existing methods of filtering and centrifugation will be performed using established assay methods for the presence of cells and cell debris as well as indicators of cell lysis. PROPOSED COMMERCIAL APPLICATION: Proposed device and methods are applicable to the clarification and sterilization needs of recombinant biopharmaceutical processing at the lab scale. It will be possible to scale up the device for pilot scale and manufacturing needs.