Celleo’s Larkem® V40 – Closed Vial Fill for Cell Therapy

Cell and gene therapies are entering rapid global expansion, yet manufacturing, not science, is now the primary constraint. Despite near-curative efficacy and >100% annual growth, capacity remains expensive, production is painstaking, and batch failure rates can reach 30%, with each failure representing a lost patient dose. Formulate and Fill is the critical final step, yet remains a manual, open process. Celleo set out to create a trusted Formulate and Fill platform that prepares ‘perfect’ samples in minutes, not hours, with precise volumes and uncompromised biology, while removing the cost, capacity and contamination risks of manual operations in high-grade cleanrooms.

Larkem fundamentally transforms the Formulate and Fill step, replacing a manual, open process with precise, closed-system automation. A novel vial design and unique filling method allows vials to be filled without risking contamination.Manifolds of vials are integrated into Larkem’s sterile, closed consumable. Once loaded, the platform creates a precision vacuum within the vial manifold, before displacing that vacuum with fluid. Finally it seals and separates the vials.Vials are filled in parallel, delivering microlitre-precision samples in minutes, with consistent homogeneity. The closed consumable architecture ensures aseptic processing, removing the need for high-grade cleanrooms and enabling scalable, operator friendly manufacturing.

Larkem improves patient access to life-changing Cell Therapies, helping transition the industry to ‘population-level’ impact.By eliminating reliance on high-grade cleanrooms, it reduces capital and operating costs while enabling safer, scalable manufacturing. Therapy developers benefit from improved consistency, reduced batch failure and greater production efficiency, increasing throughput and ROI.By automating a critical step, Larkem reduces operator burden and removes repetitive, high-risk manual tasks, improving workplace conditions. Its closed architecture lowers contamination risk and energy-intensive cleanroom use. Most importantly, its high-precision performance enables completion of previously unviable batches, allowing more patients, including paediatric and frail populations, to receive treatment.

Larkem introduces several defining design features that address critical constraints in cell therapy manufacturing. Its closed consumable architecture, combined with a novel vial design and proprietary filling method, enables fully closed, contamination-free Formulate and Fill without ever opening the vials. This removes reliance on high-grade cleanrooms and supports safer, lower-cost production environments.The platform fills vials in parallel using a controlled vacuum and fluid displacement method, delivering microlitre-precision samples in minutes with consistent homogeneity. This approach improves throughput while maintaining cell viability and product integrity across a range of biologies.The system is designed for usability and process assurance. A clean graphical user interface provides guided workflows and step-by-step verification to ensure regulatory compliance, while refined physical interactions support reliable, repeatable operation.Larkem is engineered for robustness and serviceability, with a 10-year design life, fully modular architecture and field-swappable components. Built-in system checks and remote diagnostics enable predictive maintenance and minimise downtime.The platform is designed to flexibly accommodate key applications across the global cell and gene therapy industry. It enables high-throughput GMP manufacturing, with demonstrated compliance to relevant regulatory, safety, data integrity and electronic records requirements under Celleo’s ISO9001-certified quality system.