Schematic (or artist impression) showing the end-to-end continuous process for Phase I in the clean room. [BiosanaPharma]
BiosanaPharma, an Australian/Dutch biotech company, reports that no detectable virus went into the final product during a continuous processing run lasting nine days.
Maarten Pennings, chief technology officer of BiosanaPharma, told GEN that his presentation at The Bioprocessing Summit on August 25 revealed no breakthrough of either of two model viruses used for testing of viral filtration systems.
“What we’ve shown is the removal of the virus,” he says. “There was no breakthrough in any individual fractions over nine continuous days.”
He argues this overcomes concerns about the low flow rates and pauses the company has adopted into their nanofiltration system to deliver continuous processing.
“These are unorthodox design changes, which scare people because it’s been demonstrated in the past that they could contribute to the breakthrough of a virus,” he says. “But we’ve showed this isn’t the case for this particular filter.”
On March 30, 2020, the company became the first to complete a Phase 1 clinical trial with end-to-end continuous processing, says Pennings. The trial was of a biosimilar version of omalizumab, a mAb for the treatment of allergic asthma and urticaria that has been marketed under the brand name Xolair®.
“Cost effective and biosimilars go hand-in-hand,” Pennings explains. “As we want to make biosimilars, we plan to apply all the engineering tools possible to achieve cost-effective production and going continuous is a major way to do that.”
The company had to adapt or build new equipment to go end-to-end continuous, according to Pennings. Continuous processing uses smaller machines than batch processing, he says, as the equipment is constantly processing product rather than waiting several days and dealing with an entire batch at the same time.
“By going continuous, you’re maximizing the productivity of each machine. So, if the productivity of the plant is the same, equipment size is down,” he explains, arguing that this “unparalleled sizing” challenge for equipment meant BiosanaPharma had to design its own.
The company also needed to optimize the water balance through the entire processing train, he explains. In addition, they had to meet the challenge of automating the entire process, so each unit operation followed on from the last, he says.
