The Ambr15 bioreactor system has been fitted in Gallus’s newly expanded process development facility in St. Louis, Missouri. The equipment is being used for clone selection programmes to determine which CHO(Chinese hamster ovary) cell lines are stable and produce the highest titre mAbs.
Gallus is also using Ambr15 for media selection and feed strategies for these mAbs during the development of antibodies and biosimilars, for its pharma and biopharma clients.
The contract manufacturing organisation (CMO) told us it had chosen TAP’s bioreactor to speed process development for clients. “It allows for testing multiple growth parameters and other variables simultaneously to determine the optimum conditions for achieving high titre and stability of any given protein of interest,” said Claire Rusicka, Gallus spokeswoman.
At 15ml capacity, Ambr15 is a small-scale, single-use bioreactor. The Ambr system brings together up to 48 of the 15ml reactors for growing multiple clones in a variety of conditions simultaneously.
“The media from any given clone and condition is then harvested and analyzed to determine which clones and conditions are most suitable for the next level of scale up for manufacturing larger, high purity quantities of the protein,” explained Rusicka.
Gallus also uses Hyclone and Xcellerex bioreactors, both single-use, up to 2,000L, as well as traditional stainless bioreactors up to 500L.
Second system?
Clients who outsource the manufacturing of their biotherapeutic antibodies to Gallus want them ready as quickly as possible, but also often come without any process development history for their mAb clones, said Gallus’s Scientific Director of Cell Culture Development Matt Caple.
Consequently, the company has to “build them a robust process,” he said. “We used to do this with multiple shake flask and benchtop scale bioreactor runs – in one media development project we performed 1,000 shake flasks runs – however, we knew we couldn’t continue to work at this labour-intensive scale. So we assessed a number of bioreactor models and concluded that the ambr15 system was the right option for us.”
Caple described the Ambr15 technology as “game-changing” and said the company was “running it around the clock and [is] considering buying a second system.”