Cell and Gene Therapy Catapult (CGT Catapult), an independent leading innovation and technology organisation advancing the cell and gene therapy industry, has evaluated Celleo’s Larkem® V40 for iPSC cell banking, demonstrating efficient, reproducible performance with no detrimental impact to biology.

Induced pluripotent stem cell (iPSC)-derived therapies offer unique advantages for scaling patient access as an allogeneic platform through unlimited expansion potential, high suitability to genetic engineering and their capability for multi-lineage differentiation giving rise to diverse somatic cell types. As such, iPSC-derived therapeutics are gaining traction as next generation treatments for a wide range of diseases spanning type I diabetes, neurodegenerative indications, oncology and regenerative medicine. The quality and health of the starting material – the cell bank – is a critical determinant of the therapeutic success, with efficient and reproducible vial filling vital in cell bank production.

Manual vial filling remains the industry standard for cell banking today. This creates challenges including the ability to scale production, variability in vial-to-vial and bank-to-bank consistency prolonged processing times that can intensify dimethyl sulfoxide (DMSO)-related cytotoxicity, sterility risks due to open processing, and a high demand on operator time and cleanroom resources. Automated, closed-system approaches have the potential to improve process consistency and operational efficiency in cell therapy manufacturing.

CGT Catapult conducted an evaluative study comparing Larkem® V40, automated closed vial fill system, with traditional manual pipetting for iPSC cell bank production. Key analysis included process efficiency, vial fill accuracy, output cell viability, concentration, iPSC pluripotency, post-thaw recovery, and reproducibility.

The research demonstrated that automated, closed vial filling delivers:

• Operational efficiency: Larkem® provides rapid processing ~8 minutes for 40 vials in Grade C/D environments
• Reproducible performance: Consistent vial filling outcomes with no statistical differences between 5x replicate runs on Larkem®, successfully creating a 200-vial cell bank
• Biological equivalence: Larkem® delivers equivalent cell viability, concentration, post-thaw recovery and pluripotency to manual operations

“We recently assessed the performance of the Larkem V40 for vialing induced Pluripotent Stem Cells (iPSC) for cell banking.” Commented Kelly McDonald, Lead Scientist at CGT Catapult.  “The system is designed to support the transition from manual to automated final fill processes. Fill accuracy and overall output were comparable to manual methods, while maintaining cell recovery, quality and pluripotency markers within acceptance criteria. The V40 facilitates rapid, controlled filling, which minimises DMSO exposure to reduce impact on cell health. By reducing operator handling, fatigue and process variability, the platform enables scalable, consistent and GMP-aligned automated manufacturing.”

Dr Nicholas Boyd, Head of Biology at Celleo, added: “This evaluative research highlights the role of Larkem in enabling efficient and reproducible manufacture of advanced therapies. Cell banking represents one key application Larkem supports in expanding access to transformative therapies.”

Read more about the study and detailed results in the full Application Note.