The appeal of cell culture–based production of drugs has increased the use of bioreactors. “One of the major ongoing trends comes from single-use bioreactors in clinical and commercial production facilities,” says Christel Fenge, PhD, vice president of marketing for fermentation technology at Sartorius Stedim Biotech (Göttingen, Germany). “We also see a stronger pull from the customer side to bring single-use systems into the process-development lab as it helps managing peaks and tight development schedules.”
To meet those needs, Sartorius Stedim Biotech makes a family of single-use stirred tank bioreactors that hold up to 1,000 liters, and they are working on a 2,000-liter version to be launched soon. “Our stirred tank bioreactors are based on the same design principles from bench-top systems to our largest bioreactors—both single-use and conventional stainless steel and glass vessels,” Fenge says. This enables the users to reduce the risks associated with scale-up and process transfers between different sites.
Recently, Sartorius Stedim Biotech released a 2-liter single-use system. “This also uses the same design principles,” Fenge explains, “so it allows seamless transfer from small to large scale.” She adds that their bioreactors can be connected to process analytical technology tools, including design-of-experiments and multivariate-analysis software, together with additional sensors to make the bioreactors more intelligent.
Other companies see similar trends. As Jennifer DeKarski, global product manager for single-use bioreactors at EMD Millipore (Billerica, Mass.), says, “In general, we’re seeing strong growth in the single-use bioreactor market—at all scales.” She also points out a wide range of applications for these bioreactors, including monoclonal antibodies, recombinant proteins, stem cells, and vaccines.
In this area, EMD Millipore offers its Mobius CellReady single-use bioreactor platform. A 3-liter version has been on the market a couple of years, and the company recently released 50- and 200-liter versions.
All of the larger scale single-use bioreactors from EMD Millipore utilize the Mobius SensorReady technology, an external circulating loop that contains the sensing ports and sampling access. “You can configure sensing and sampling at the point of use and integrate new sensors as they become available, instead of using custom bioprocess containers,” DeKarski explains. “Our standard bag is stocked, reducing the lead time of a customized solution.”
To scale up a process from basic research to manufacturing—as both Sartorius and EMD Millipore help customers do—it is crucial to keep the system consistent. This allows the process to be controlled in the same manner from development to clinical use.
Methods of mixing
To keep cells alive in a bioreactor, the medium must move. Some bioreactors stir the contents and others rock them. “We have a full range of stirred and rocking bioreactors,” says Morgan Norris of the bioprocessing team at GE Healthcare (Chalfont St. Giles, U.K.). The company’s Xcellerex XDR stirred tanks range from 4.5 liters to 2,000 liters, and its rocking tanks cover 0.1 liters to 500 liters. “Both stirred and rocking bioreactors have different uses and purposes,” Norris says. For example, GE’s WAVE bioreactor for 0.1 liters to 500 liters can be used for R&D, process development, and current good manufacturing practices.
GE’s WAVE bioreactors use a rocking motion. The generated waves mix the contents and transfer oxygen to the cells. Like other single-use systems, these require no cleaning or sterilization. In addition, Norris says, “It’s easy to get up to speed on a rocking bioreactor. That drives some of the interest in academia for our smaller rocking tanks.” As Norris adds, “Improving the productivity on the academic side will lead to more targets and ideas for the industry to study.”
About the author
Mike May is a publishing consultant for science and technology based in Houston, Texas.
Filed Under: Drug Discovery
