Award-winning system automates vial filling for cell therapy

A Melbourne company’s answer to one of the bottlenecks holding back cell therapy has been named a winner in the 2026 Australian Good Design Awards, with Celleo’s Larkem V40 recognised in the Product Design (Medical and Scientific) category.

Cell therapies — such as the CAR-T treatments used against leukaemia, lymphoma and multiple myeloma — have produced lasting remissions in some patients whose cancer had come back after other treatments. They are also among the hardest medicines in the world to make, as most are autologous: built from a patient’s own cells, modified, grown and tested over several weeks, then returned to that one patient. Every dose is a manufacturing run of its own, and manufacturing capacity is one of the main limits on how many people are treated.

Every batch needs vials, and these are typically drawn up by hand and pipetted one at a time, inside the most stringent class of cleanroom. The process is extremely slow, varies from vial to vial, risks compromised sterility from open processing, and ties up skilled staff and resources.

By contrast, the Larkem V40 does this job automatically, inside a sealed, single-use kit. Up to 40 vials are filled at once — to a precise, consistent volume — without ever being opened to the air.

Celleo’s Larkem V40 closed vial filling system, with the single-use consumable and finished vials. Image: Celleo.

The system works by evacuating air from the closed set incorporating the vials, before displacing the vacuum with fluid. The manifolded vials are automatically sealed and separated, providing industry-standard vials for subsequent use. A 40-vial fill takes around eight minutes, as opposed to half a day for a manual batch.

Because the cells never leave the sealed kit, the system can run in a lower-grade cleanroom — which most facilities already have — instead of the specialised, heavily controlled suites that are costly to build and in short supply. This means less reliance on the most expensive room in the building, and faster, more consistent dosing for patients.

Celleo built the V40 after more than a hundred interviews with the scientists and operators who make cell therapies. The design brief was to close the process, automate it, and make it simple enough that an operator trusts it on the first day.

“Everything about the V40 design — from the nuances around single-use packaging to the high-definition user interface — evolved out of extensive voice of customer,” said Mark Rob, Chief Technology Officer and co-founder of Celleo. “You know a good design in manufacturing when end users embrace it intuitively, with little more than a quick introduction.”

Finished vials from Celleo’s Larkem V40. Image: Celleo.

Two independent evaluations of the Larkem V40 have been published this year. Cell and Gene Therapy Catapult evaluated the system for iPSC cell banking at its Edinburgh laboratories, creating a 200-vial cell bank with no statistical differences between five replicate runs, and equivalent cell viability, concentration, post-thaw recovery and pluripotency to manual operations. CCRM Nordic evaluated the system for QC sample provision in a CAR-T workflow at its Gothenburg facility, reporting increased volume filling accuracy compared with manual vial filling, with viability, cell concentration, phenotype and potency equivalent to manual operations.

The Good Design Awards Jury concluded that the Larkem V40 is an innovative solution addressing a critical unmet need in cell and gene therapy manufacturing.

“The platform’s fully closed, automated vial filling system represents a significant technical achievement, replacing manual, contamination-prone processes with precise, scalable automation that eliminates reliance on high-grade cleanrooms,” the Jury said. “The Jury commends the team for tackling a complex manufacturing challenge with the potential to reduce batch failure rates, lower contamination risk and meaningfully improve patient access to life-saving therapies, demonstrating a well-informed product package with far-reaching healthcare impact.”

Top image: An operator removes finished vials from Celleo’s Larkem V40. Image: Celleo.