An enhanced roller bottle concept is proposed. A roller bottle with an 8 fold or greater increase in bottle capacity will significantly aid operations in which multiple cultures are maintained. Importantly, tissue engineering is experiencing rapid growth. For many applications, one rate limiting step is availability of tissue and the need to expand small samples to clinically relevant endpoints. A compact, high capacity cell culture device with direct oxygenation (enhanced roller bottle) will be valuable. In autologous cultures, a compact, high capacity device that is modular, and efficient is needed. The device will be single use and simple to operate. Feasibility testing of the critical features required for such a device is to be done. The gas exchange/growth surface will be proven out. Multiple approaches will demonstrate robustness of the concept. The most suitable candidate will be incorporated into scale prototypes for device design prove out. Cell inoculation, capacity and recovery following culture will determine feasibility of the existing concept. Evaporative loss and medium foaming will be evaluated. If required, alternative designs will be tested. Final revised prototypes will be tested in the expansion of chondrocytes by an independent laboratory involved in a clinical trial using expanded chondrocytes.
Annual use of roller bottles for cell culture is estimated to be between 25-40 x 106 bottles per year in the United States alone. The enhanced roller bottle is intended to be equivalent to at least 8 existing bottles with regards to the capacity of cells that can be supported. The enhanced roller bottle is envisioned to be an ideal device for tissue engineering as well as numerous other cell culture applications.
