Monday, July 30, 2007 - 10:15 AM
S4

Development of the Wave bioreactor-ten years from prototype to GMP acceptance

Vijay Singh, GE Healthcare Wave Products Group, 300 Franklin Square Dr., Somerset, NJ 08807

The development of the Wave Bioreactor began just over 10 years ago. It was the infancy of wide-spread industrial cell culture and the challenges were just emerging. Clearly, the only scalable cell culture platform at the time was the stainless-steel stirred tank with its inherent limitations of cell shear and bubble damage. From an industrial standpoint, the stirred tank was very expensive to maintain, sterilize, operate, and validate. The Wave Bioreactor was designed to be very simple bag type bioreactor that minimized shear and cell damage, yet could be scaled up to 500 liters and beyond. The simplicity of the design based on an inflated culture bag and a rocking platform and its stellar performance brought in the early adopters and the device ushered in a whole new era of disposable bioprocessing equipment. The Wave Bioreactor went from a laboratory curiosity to a research tool, then an inoculum propagation device, to finally a GMP manufacturing platform. Over the years many applications ranging from cell culture, virus production, vaccine manufacture, cell therapy, have all been successfully run in the Wave Bioreactor and over a thousand units are in operation worldwide in R&D and GMP manufacturing applications. In addition to discussing the technical problems that needed to be solved in developing a ground breaking technology, this talk will also focus on dealing with ways of gaining acceptance in a very conservative industry and the many perils and pitfalls encountered in developing a commercial product.