Key Findings
The Larkem V40 is a closed vial filling system designed to eliminate the manual bottlenecks associated with cell therapy production. By automating the filling process within a sealed, single-use kit, the system can fill up to 40 vials in approximately eight minutes. This represents a significant time reduction compared to manual batch processing, which typically takes half a day.
Technical Details
The system operates by evacuating air from a closed set containing the vials and then displacing the vacuum with fluid to ensure precise and consistent volumes. Because the cells remain within a sealed kit and are never exposed to open air, the process can be conducted in lower-grade cleanrooms rather than the costly, high-grade specialized suites usually required for manual pipetting. The system’s design, including the high-definition user interface and single-use packaging, was developed based on over one hundred interviews with scientists and operators.
Background & Context
Cell therapies, such as CAR-T treatments for leukaemia, lymphoma, and multiple myeloma, are predominantly autologous, meaning they are built from a patient’s own cells. This requirement makes every dose a unique manufacturing run. Traditionally, vials are drawn and pipetted by hand in stringent cleanrooms, a process that is slow, prone to variability, and risks sterility compromises.
Significance & Outlook
Two independent evaluations published this year validate the system’s performance. Cell and Gene Therapy Catapult tested the Larkem V40 for iPSC cell banking in Edinburgh, finding no statistical differences between five replicate runs and results equivalent to manual operations regarding cell viability, concentration, and pluripotency. Additionally, CCRM Nordic evaluated the system for CAR-T workflow QC sample provision in Gothenburg, reporting increased volume filling accuracy compared to manual methods while maintaining equivalent potency and phenotype. These results suggest the platform can reduce batch failure rates and improve patient access to life-saving therapies.
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