Recombinant research has facilitated the in vitro production of mammalian cell-secreted products. These products are used in the in vitro and in vivo diagnostic and therapeutic setting. Products that have been approved or are in the approval process have projected market needs on the order of 100 kilograms per year, but large quantities like this will be difficult to produce using today's state-of-the-art cell culture methods. A new hollow-fiber bioreactor has been developed that can meet these production needs in a cost-effective manner. The device has all of the advantages of hollow-fiber cell culture: high cell density, low culture volumes, high product concentration and purity, low serum/growth factor requirement, and compact size. The bioreactor is a novel design that is easily manufactured without large investments in capital equipment and is linearly scalable. The device can transfer oxygen at a rate of 196 mM/hour/liter.The Phase I research objective is to generate the data required to optimize the design of the commercial bioreactor. This bioreactor will allow very large-scale mammalian cell culturing with less space and reduced equipment costs than current cell culture methods. This research will lead to Phase II development of the bioreactor and lay the groundwork for improved cell-culture instrumentation development.
Anticipated Results:Therapeutic and diagnostic applications of mammalian cell-secreted proteins have created a large demand for improved in vitro production methods. Phase I research will improve existing large-scale cell culture methodology. This development will reduce production costs through increased productivity and reduced raw material and downstream purification costs. Thus, several proteins (e.g., human insulin, interferon, and tPA) will become less expensive and more available.National Institute Of General Medical Sciences (NIGMS)
