Single-use bioreactors are “spreading more and more” Günter Jagschies, PhD, an expert in biopharma manufacturing and the strategic customer relations leader at GE, told us.
The primary advantage includes “the shorter time it takes to set up a facility,” as companies can save between six months and several years if they use single-use bioreactors rather than stainless steel bioreactors, he said. The simpler design of single-use tech also allows companies to “delete all of the piping” in a facility because disposable bioreactors rely on a simpler bag-based design, Jagschies said.
Excess capacity, which can be problematic when steel bioreactors aren’t in use, is also not an issue for disposable bioreactor users, he added, noting the shorter time it takes to install single-use technology.
The process of shifting between different cells and chemicals in the bioreactor can also be shortened with disposable bioreactors as companies utilizing this tech “wouldn’t need to validate the cleaning” of a reusable bioreactor, he said.
Contamination in bioreactors -- which some say infects between 1-3% of bioreactors and causes interruptions in runs -- will also be nearly eliminated with single-use bioreactors.
Case by Case Review
However, single-use technology is not an end-all solution for every company’s woes in speeding up its biopharma manufacturing processes.
Jagschies said that companies need to decide on a case by case basis if it's a solution worth pursuing. If a company has a marketed product that uses an entire facility, or even between 60% and 80% of a facility’s capacity, then a reusable bioreactor might be a better option, he noted, because “the cleaning agents aren’t that expensive” when compared to consumables used for single-use bioreactors.
Jagschies also noted that companies in developing countries are not yet shifting to single-use bioreactors because the labor piece of their cost puzzle is not as high as it is for Western companies so cleaning the equipment becomes less of a cost factor. He added that most companies in the developing world also have one molecule so they don’t need to switch as quickly as other companies.
Other potential question marks for using disposable bioreactors are the limitations around disposable chromatography and disposable sensors.
But the biggest players -- including Amgen, GlaxoSmithKline, Genentech and Roche – are “all publishing and talking about using single-use,” Jagschies said.
Expectations for Single-Use Tech
The single-use technology market is estimated to more than quadruple over the next few years, and will increase the need for compatible bioreactors of volume less than 2000L because of the growing number of niche products, Benoit Massé, managing partner of the consulting firm AllyPrime, told us.
“Without a doubt, disposable solutions are the most promising technology that will help drug manufacturers lower their costs,” Massé said. He recently published a report on strategies for suppliers in the biopharma industry.
Among the findings of the report, Massé found that biopharma global production capacity is dominated by Roche, which has 25% of the world’s capacity. Other major players include Johnson & Johnson, Boehringer Ingelheim, Amgen and Lonza.
He also noted that single-use bioreactors “are relatively expensive and have to be handled correctly to avoid damage. Construction of the bags requires mechanical welding of the seams and this needs to be of the highest quality in order to ensure that welds do not come apart and result in lost sterility and consequently loss of the entire run.”