MEMBRANE BASED ROLLER BOTTLE

描述（由申请人提供）：目前进行细胞培养以生产少量和大量细胞和细胞分泌产物，如生长因子、酶、激素、单克隆抗体、干扰素、白细胞介素、疫苗、诊断剂和病毒载体。多种市售的基于膜的细胞培养装置可用于培养已适应悬浮培养的哺乳动物细胞。然而，越来越多的工业上重要的细胞是锚定依赖性的。现有的基于膜的装置缺乏用于贴壁细胞附着的适当材料，并且具有次优的表面积。基于膜的滚瓶（MBRB）是一种实用的、具有成本效益的培养装置，旨在满足这一需求并提高培养生产率。MBRB将传统滚瓶的简单性与基于膜的属性相结合。在拟定的II期研究中，MBRB将针对贴壁依赖性细胞、细胞分泌产物和细胞转导的生产进行优化。具体目标包括进行彻底的机械设计调查，然后进行现场和非现场应用测试。基于膜的研究和临床规模的滚瓶装置的商业化预计将导致更有效地利用生物技术资源。在第二阶段完成时，MBRB将针对中小型培养设备的制造商，用于生产用于诊断和治疗应用的细胞或细胞产品。

DESCRIPTION (provided by applicant): The culture of cells is currently undertaken to produce small and large quantities of cells and cell-secreted products, such as growth factors, enzymes, hormones, monoclonal antibodies, interferons, interleukins, vaccines, diagnostics, and viral vectors. A variety of commercially available membrane-based cell culture devices are available for the culture of mammalian ceils that have been adapted to suspension culture. A growing number of industrially important cells, however, are anchorage-dependent. Existing membrane-based devices lack the proper materials for adherent cell attachment and have sub-optimal surface areas. The membrane based roller bottle (MBRB) is a practical, cost effective culture device designed to meet this need and improve culture productivity. The MBRB combines the simplicity of the traditional roller bottle with membrane-based attributes. In the proposed Phase II studies, the MBRB will be optimized for the production of anchorage-dependent cells, cell-secreted products, and cellular transduction. Specific aims include a thorough mechanical design investigation followed by on-site and off-site application testing. The commercialization of a membrane-based family of research and clinical scale roller bottle devices is expected to lead to a more efficient use of biotechnology resources. At the completion of Phase II, the MBRB will be targeted to manufacturers of small and mid-scale culture devices for the production of cells or cell products for diagnostic and therapeutic applications.