Antleron will apply its iterative development toolbox, combining Quality-by-Design, in silico simulations, soft sensing and additive manufacturing to support the identification of novel applications and features for VivaBioCell’s NANT XL bioreactor system.
Suitable manufacturing technologies for ATMPs have only been adapted or launched in the last few years. Autologous, cell-based products are particularly challenging due to their personalized nature. Despite several systems being now available for cell therapy manufacturing, manual processes are still well established and prevalent. This can lead to major consequences such as rapidly rising costs associated with trained staff and cleanroom space as the product progresses through the pipeline to the market. High ATMP costs are one of the major challenges the field must tackle to ensure broader patient access and commercial success, particularly in case of autologous therapies.
Fully closed and automated systems, such as the NANT XL, aim to lower the necessity for operator interventions as well as lower the cleanroom requirements for production facilities. Additionally, automated protocols reduce the risk for operator error, allow for more precise culture parameter control and documentation management.
Together, the Antleron and VivaBioCell teams are looking to push the limits of the NANT XL bioreactor technology to facilitate cell-based medicines through sustainable manufacturing solutions. The Antleron development toolbox will be applied to the bioreactor system to assess expansion processes of various cell types relevant to the ATMP field while the VivaBioCell team provides their expertise and insight about the development and operation of the NANT XL in context of relevant bioprocesses. Together, both teams aim to identify and integrate new process features for the technology.
Additionally, parties in the BeNeLux area can reach out to the Antleron team and discuss possibilities for cell expansion test runs on the NANT XL bioreactor.
Both companies’ drive to enable sustainable solutions for personalized medicine will drive this co-creative development effort. Improving treatment quality and lowering cost will ultimately benefit patients.