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Despite a wealth of experience from previous projects, more efficient drug manufacturing processes are still possible and needed. The TRD team in Klybeck, under the leadership of Romain Pastor (left) and Fabian Kebbel, is currently proving this with XXB750, a biologics drug candidate against resistant high blood pressure and heart failure.
XXB750 is an antibody, i.e., a biological agent, which requires cell cultures for its production. “We developed the process to move from the traditional Fed-batch process to the continuous manufacturing process,” says Romain Pastor.
The technology enables the transition from large stainless-steel tanks used for processes with a volume of up to 20000 liters to smaller mobile tanks with a volume of up to 1500 liters and single-use consumables used for continuous manufacturing.
The technology allows for the creation of flexible and more efficient manufacturing plants. Furthermore, the continuous manufacturing process makes production more efficient in terms of output, environmental sustainability and time to market.
“An important improvement to our continuous processes is the high-density perfused batch,” says Romain Pastor.
Thanks to this innovative process, cells thrive and multiply efficiently, producing antibodies in optimal conditions. They are “fed” every day with fresh nutrients, while antibodies and metabolic waste products are removed continuously.
“This process enables us to produce about 10 times more output per bioreactor volume than the traditional batch process,” says Romain Pastor.
Since Plant One and Plant Zero are identical in scale and equipment, all the findings from the pilot plant could be incorporated into the final production plant without any loss of time.
When asked whether, in addition to the technical aspects, there were other approaches to speeding up the development work for XXB750, Fabian Kebbel said: “In contrast to previous projects, all of TRD’s work steps here in Klybeck are closely situated. This proximity makes collaboration easier and faster.”
This also benefits Kebbel’s Drug Product team, who is developing the final product in patient-friendly syringes in the building opposite, just a few meters from Romain and the continuous manufacturing facility.
“The regular exchange between the individual TRD areas also promotes cohesion and team spirit – ultimately, success is based on the whole team and not just on individual players,” Kebbel adds.
