BioProcessors (Woburn, MA) has developed a microbioreactor array system for high-throughput process development. The “SimCell” system applies miniaturization, microfluidics, automation, and remote monitoring and control to increase mammalian cell culture experiment capacity by as much as two orders of magnitude.

The SimCell system is configured as an array of six microbioreactors on a plate that has essentially the same footprint as a 96-well plate, with each reactor having a capacity of approximately 700 µL of liquid—a significant scale down from traditional 1-10 L capacity reactors.

The company recently completed Phase 1 of a long-term joint project with Amgen (Thousand Oaks, CA), in which it demonstrated the potential of the SimCell technology as part of a larger robot-centered system consisting of a series of unit operations, including rotating incubators, measurement stations (e.g., for pH, CO2, biomass), and filling stations.

“Ultimately, the goal of doing these processes is to apply it to a manufacturing process. The results that we have and that have been released by Amgen show that the data from the bioreactors matches perfectly with benchtop bioreactors in terms of monoclonal antibody productivity,” says Steve Tingley, vice-president of corporate development for BioProcessors. “In effect, people can scale from our system directly into their production system in the same way that they do today when they scale up from benchtop reactors to production labs.”

The system also has been designed to address the needs of manufacturers to better understand their processes, which is in line with current goals of FDA’s process analytical technologies (PAT) initiative. “The general complaint from the process development world in biotechnology manufacturing is that they don’t have enough information, they don’t know their processes well enough, and they don’t have the best processes. So typically people will do as much process development as they can in the short time they have before they have to lock the process down,” says Tingley. “With our system, we can now do thousands of experiments in that time. The payoff is a much better understood process and potentially finding a process that is going to deliver 1.5 g/L of product instead of 600 mg/L. It also could potentially identify a process where product quality would be higher.”

–Maribel Rios