Bioprocessors always look for ways to make more product in less floorspace and at a lower cost. “A major challenge in manufacturing adherent cells for advanced therapies is producing the large quantities of cells needed in a cost-effective manner,” says Tara St.Amand, PhD, director of business technology, bioprocess, at Corning. “Space constraints often hinder large-scale bioproduction, and labor-intensive processes add time and cost to mid-to-large scale biotherapeutic production.”
St.Amand points out that advances in production are really needed with gene therapies based on recombinant adeno-associated viral and lentiviral vectors. “With the rapidly growing number of clinical trials underway and planned, the industry needs scalable, cost-efficient systems for manufacturing cells and cell products, such as viral vectors,” she says.
In August at the 2021 Bioprocessing Summit in Boston, Corning introduced its Ascent Fixed Bed Reactor system. St.Amand describes this system as “an adherent cell-culture platform designed to deliver significant surface area intensification and high-yield bioproduction cost efficiently.”
When asked what key technological improvements make this platform different, St.Amand highlights the bioreactor design. “It features a specially treated and packed woven polymer mesh substrate that is designed to provide uniform fluid dynamics, even media and cell distribution, and efficient waste media removal,” she explains. “Depending on the desired application, preliminary test data show transfection efficiencies greater than 90% and cell harvests with yields and viability greater than 90%.”
In some cases, bioprocessors also need a platform that could run in most any lab. The Corning system can be used without a biosafety cabinet or cleanroom. “Aseptic connectors allow the user to remove the bioreactor vessel for sampling inside a laminar flow hood without interrupting a run,” according to St.Amand.
In the future, Corning plans to scale up this platform—reaching volumes as high as 1,000 square meters. “The linear scalability of the platform, combined with the viable cell harvest capability, is designed to enable each bioreactor to serve as a seed train for the larger bioreactors,” notes St.Amand. Even more lies ahead, because she states that while the initial focus is on viral-vector production, the Ascent platform will also support “other advanced therapy workflows that require the harvest of significant volumes of cells, such as regenerative medicine.”