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Invitrogen’s Push in Bioprocess Intensification

PharmaManufacturing.com
07/20/2006

Process development is one of the most critical aspects of bioprocessing, especially as it influences productivity for final product manufacturing. New technologies are helping manufacturers to optimize performance in bioreactors. Rather than experimenting in full-scale reactors, they are running hundreds of micro-scale tests simultaneously to find the optimal set of cell-culture components and process conditions. The payoff is a much better process understanding and a much lower risk heading into full-scale manufacturing.

Bioprocess development has long been the bailiwick of Invitrogen (Carlsbad, Calif.). To stay ahead of the curve, the company has recently installed BioProcessors Corp.’s (Woburn, Mass.) SimCell automated cell-culture system in its Grand Island, N.Y. facility. The system is presently being offered through beta projects with several clients, and will become commercially available as part of Invitrogen’s PD-Direct line of solutions in November, says Trent Carrier, Invitrogen’s business area manager for PD-Direct.

Invitrogen sees the SimCell technology as an opportunity to greatly multiply the parameters by which scientists can test a variety of process conditions and media components, Carrier says. The multivariate analysis made possible by monitoring cell performance in the SimCell microbioreactor will help clients to better identify optimal conditions for bioproduction. Amgen is one company that has already used SimCell extensively on its own.

An Invitrogen scientist in Grand Island, N.Y. conducts a process development study on the SimCell system.

SimCell uses microfluidic chambers as miniaturized bioreactors that can simulate large-scale conditions. The chambers have small ports through which pH, dissolved oxygen and other bioreactor conditions are modified. Plates housing the chambers are spun to create different agitation rates and shear forces, simulating myriad reaction conditions.

“The SimCell experiments show strong correlations to those conducted on clients’ traditional bioreactor systems in both yield and growth rates,” says Carrier, enabling what he calls “high-fidelity screening.”

“For each plate and each well, you can independently monitor pre-set conditions,” he says. “It’s really the first high-throughput technology by which you can manipulate processing parameters and get predictive results.”

Many of Invitrogen’s clients have expressed in screening multiple cell-culture candidates using SimCell before moving on to GMP banking and manufacturing activities, he says. They are also interested in developing a more complete data set by which to assess their critical operating parameters, aiding process validation packages. Finally, several have expressed interest in exploring a wider variety of media components and combinations for customized media. In any application, SimCell improves accuracy and timeliness in process development, Carrier says.