More Competition and Choices
Despite the spate of mergers and acquisitions among vendors of single-use equipment, end-users feel there is a greater diversity of available products and more competition and choice today than ever before. Vendors are moving vertically and horizontally from their original positions as suppliers of storage bags, membranes, or reactors to supply integrated systems with broad processing ability in completely or nearly completely disposable format.
GE Healthcare’s Wave Biotech division, a leader in bioreactor bags for years, now faces competition from Xcellerex, Thermo Scientific Hyclone, and Applikon Biotechnology.
Working volumes in Wave bags, whose contents are agitated through rocking on a mechanical table, go up to 500 L, whereas the Xcellerex XDR™ Single-Use Bioreactors, which are supported by a stainless steel tank, feature volumes of up to 2,000 L.
Xcellerex has published an economic analysis on its website that claims its bioreactors can reduce capital investment by 75%, lower operating costs by 35%, and accelerate time to start-up by 10 months compared with conventional stainless steel equipment.
Xcellerex also offers a disposable mixing system at volumes of up to 1,000 L, the XDA disposable, single-use product contact assembly that includes gas filters, agitation system components, sparge components, probes, ports, pressure sensors, sampling ports, and gas and liquid transfer tubes.
Intermediate in size are Thermo Scientific Hyclone’s BioProcess Container™ systems, with volumes ranging from 50 mL to 1,500 L. Applikon serves the low-volume side of the business with its Appliflex process bags, available in 10, 20, and 50 L sizes and fitted with sensors for measuring temperature, pH, and dissolved oxygen. Like Wave, Applikon agitates bioreactor bags by rocking them on a mechanical platform.
Disposable reactor bags provide many advantages over stainless steel tanks but scale-up with bags has its problems, notes Michiel E. Ultee, Ph.D., senior director for process sciences at Laureate Pharma.