CENTRIFUGE/FILTRATION SYSTEM OR BIOPROCESS CLARIFICATION

离心机/过滤系统或生物工艺澄清

• 批准号: 6310928
• 负责人: GLEN E JORGENSEN
• 金额: $ 9.82万
• 依托单位: MEDICEPT, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-03-02 至 2001-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6310928
• 关键词: biomedical equipment development; centrifugation; fermentation; fluidity; growth media; method development; tissue /cell culture; tissue /cell preparation

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.

描述（申请人的摘要）：该项目建议建立和验证 具有无菌一次性衬里的高效实验室比例离心机 在离心机中将亚微米滤波器元件纳入以创建一个 非常强大的方法来阐明和消毒细胞培养物 重组生物药物的生产。效率和速度 已经预测了细胞和培养基的冷混合的离心过程 使用流体动力学建模。使用5升实验室量表81i/min的吞吐量 设备可实现10,000 g。提出的设备和方法将 产生非常快速，彻底的净化并澄清产品 LADEN增长媒体。由于相对速度 该过程以及低剪切和加热环境。在这个过程中非常 可以生产干净的产品。实验室比例测试，细菌和 哺乳动物细胞培养物将由主任Alexander Dilorio博士进行 伍斯特理工学院的生物处理实验室。展示 新设备和过程的有用性。比较测试与 现有的过滤和离心方法将使用 建立的测定方法，用于存在细胞和细胞碎屑以及 细胞裂解的指标。 拟议的商业应用： 建议的设备和方法适用于澄清和灭菌需求 在实验室量表上重组生物药物处理。 有可能 扩展设备以达到飞行员规模和制造需求。