Traditional fed-batch bioreactor systems are typically run between 7-21 days. During the run, cells consume the media nutrients, release toxic metabolites and wastes in the culture and secrete the protein of interest into the media, and at the end of the run the protein is separated from cell mass. After the lot of improvements and technological advancement, Fed-batch processes has not improved other issues including large manufacturing footprints and challenges with scalability.
By keeping the cells contained within the culture, perfusion bioreactors can culture cells over much longer periods, even months, by continuously feeding the cells with fresh media and removing spent media. In perfusion, there are different ways to separate the cells from the culture fluid while removing spent media. Most commonly used separation devices are Tangential filtration systems (TFF) or Alternating tangential filtration systems (ATF) that keep the cells in the bioreactor while allowing the media to be removed. Another method is the use of a centrifuge to separate cells and return them to the bioreactor.
The currently used separation devices for perfusion cultures are limiting the users in terms of low perfusion batch scalability (up to 1000L), recurrent filter clogging problems and exert shearing forces to the cells while their separation. Due to these bottlenecks, bioprocess industry lacks the perfusion enabled microbioreactors (100 ml) and scaled up version of perfusion bioreactors (>2000L).
The PerfBRx™ bioreactors are truly scalable bioreactor technology for high cell density perfusion cell culture. They are the world’s first, perfusion integrated single-use bioreactors encompassing the novel separation device with linearly scalability from 0.1 L to 5000L scale.
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Technology is under development.