ENHANCED ROLLER BOTTLE

描述（由申请人提供）哺乳动物细胞或其分泌蛋白大规模生产的进展导致许多治疗和诊断产品获得许可。搅拌槽和中空纤维生物反应器等培养设备在大规模生产中具有实用性，但在研究规模上不切实际且成本过高。传统的滚轮瓶已经成功地用于中小规模的重组蛋白、病毒载体和治疗细胞剂量的生产，但这是劳动密集型的，通常需要10台以上的设备来生产每个所需的产品。增强型滚瓶（ERB）是一种实用的、成本有效的细胞培养设备，旨在提高培养效率。与传统的滚轮瓶相比，ERB增加了细胞附着的表面积，并由于其透气性壁而增加了培养基的可用性，从而使细胞产量增加了4- 9倍。在拟议的II期研究中，ERB将被优化以生产锚定依赖性细胞和细胞分泌产物。需要研究的ERB参数包括气体传递、支架结构和材料、接种方法、操作条件和产品回收率。II期完成后，ERB将面向生产用于诊断和治疗用途的细胞或细胞产品的中小型培养设备的制造商。

DESCRIPTION (provided by applicant)Advances in large-scale production of mammalian cells or their secreted proteins have led to the licensure of many therapeutic and diagnostic products. Culture devices, such as stirred-tank and hollow fiber bioreactors, have utility in large-scale production, but are impractical and cost prohibitive at the research scale. Traditional roller bottles have been used successfully for small to mid-scale production of recombinant proteins, viral vectors, and therapeutic cell doses, but are labor intensive, typically requiring more than ten devices for each desired product. The Enhanced Roller Bottle (ERB) is a practical, cost effective cell culture device designed to improve culture productivity. The ERB increased cell production 4- to 9-fold over the traditional roller bottle by increased surface area for cell attachment and increased availability of culture medium due to its gas permeable walls. In the proposed Phase II studies, the ERB will be optimized for the production of anchorage-dependent cells and cell-secreted products. ERB parameters requiring investigation include gas transfer, scaffold configuration and material, inoculation methods, operating conditions, and product recovery. At the completion of Phase II, the ERB 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.