ENHANCED ROLLER BOTTLE

描述（由申请人提供）哺乳动物细胞或其分泌蛋白的大规模生产的进展已经导致许多治疗和诊断产品的许可。培养装置，如搅拌槽和中空纤维生物反应器，在大规模生产中具有实用性，但在研究规模上是不切实际的并且成本过高。传统的滚瓶已经成功地用于重组蛋白、病毒载体和治疗性细胞剂量的小规模至中等规模生产，但是是劳动密集型的，对于每个期望的产品通常需要超过十个装置。增强型滚瓶（ERB）是一种实用、经济的细胞培养设备，旨在提高培养生产率。ERB通过增加细胞附着的表面积和由于其透气壁而增加的培养基可用性，使细胞产量比传统滚瓶增加4至9倍。在拟定的II期研究中，将优化ERB以生产贴壁依赖性细胞和细胞分泌产物。需要调查的ERB参数包括气体转移、支架配置和材料、接种方法、操作条件和产品回收。在第二阶段完成后，再培训局将面向中小型培养设备制造商，用于生产诊断和治疗应用的细胞或细胞产品。

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.