CENTRIFUGE/FILTRATION SYSTEM OR BIOPROCESS CLARIFICATION

描述(申请人摘要)：该项目建议建立和验证一个 带有无菌一次性衬垫的高效实验室规模离心机 在离心机内安装亚微米过滤元件以产生 用于澄清和灭菌细胞培养物的非常可靠的方法 重组生物制药的制造。它的效率和速度 细胞和培养基冷混合物的离心过程已经被预测。 使用流体动力学建模。使用5升实验室规模，吞吐量为81I/分钟 装置可以用10,000克来实现。所提出的装置和方法将 对产品进行快速、彻底的提纯和澄清 拉登成长媒体。细胞裂解将被最小化，因为相对速度 该工艺与低剪切和加热环境有关。在这个过程中， 可以生产出清洁的产品。酵母菌、细菌剂和 哺乳动物细胞培养将由亚历山大·迪洛里奥博士进行， 伍斯特理工学院生物处理实验室。要演示 新设备和新工艺的实用性。对比测试与 现有的过滤和离心法将使用 已建立的细胞和细胞碎片的存在以及 细胞溶解的指示物。 建议的商业应用： 所提出的装置和方法适用于澄清和灭菌的需要 实验室规模的重组生物制药加工。它将有可能 扩大该设备的规模以满足中试规模和制造需求。

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.