Recombinant research has facilitated the in vitro production of mmmlian cell secreted products. These products are used in the invitro and in vivo diagnostic and therapeutic setting. Products that have been approved or are in the appr-oval process have projected market needs on the order of 100 kilogram per year. The requirerwnts of 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 manufacttured without large investments in capital equipment and is linearly scalable. The device can transfer oxygen at a rate of 196 mM/hour/liter (K1a=3920 hrs=1). The proposed Phase I research objective is to gbenerate the data required to optimize the design of the commercial bioreactor. This bioreactyor will allow very large scale mammalian cell with less space and reduced equipment costs when compared to today's state of the art cell culture methods. This research will lead to Phase II development of the commercial bioreactor and lay the groundwork for improved cell culture instrumentation development.
