Adva Biotechnology Ltd. and Autolomous Ltd. today announced the launch of the Digital PIONEER Program, a joint initiative aimed at digitising, decentralising, and scaling out autologous cell therapy manufacturing. GenCART Inc., a promising clinical-stage biotechnology company, has joined as the first clinical partner, bringing its therapeutic expertise to help validate the integrated platform through real-world application.
The Digital PIONEER Program combines Adva’s automated manufacturing technologies with Autolomous’ cloud-based orchestration software to deliver a fully integrated, digital, and scalable manufacturing solution. The model supports decentralized and scale-out deployment, enabling personalized therapies to be produced closer to patients, with higher throughput and greater consistency.
As the first program participant, GenCART Inc. brings critical therapeutic insight to validate the system across lab-scale and pilot production phases. The company will contribute protocols, biological material, and performance data to help demonstrate the clinical and operational benefits of the integrated platform.
“The Digital PIONEER Program is a foundational step toward reshaping how cell therapies are manufactured,” said Dr. Ohad Karnieli, CEO of Adva Biotechnology. “By automating the process and embedding digital control across the lifecycle, we can enable scalable, decentralized production models that reduce time-to-patient and improve quality.”
“We’re proud to power the digital orchestration layer of this next-generation manufacturing model,” said Alexander Seyf, CEO of Autolomous Ltd. “The Digital PIONEER Program proves that the combination of intelligent automation and digital infrastructure can support truly distributed, compliant, and scalable production for advanced therapies.”
“GenCART is excited to be the first clinical partner in the Digital PIONEER Program,” said Dr. Mounzer Agha, Founder and CEO of GenCART Inc. “We believe that integrating automation and digital systems is essential to delivering high-quality cell therapies at scale. This collaboration aligns with our mission to bring life-saving treatments to patients faster, more reliably, and with uncompromising clinical rigor.”
The program will progress through four phases – from system integration and lab validation to pilot runs and public demonstration. Additional early adopter partners are expected to join subsequent phases.