Cellipont and Xiogenix White Paper Shows Automated Fill-Finish Maintains Cell Viability Across 17-Fold Scale-Up
核心洞察
Cellipont Bioservices (搜索) and Xiogenix (搜索) published a white paper evaluating the ARES X20+ (搜索) automated fill-finish platform for cell and gene therapy manufacturing.
The evaluation demonstrated consistent formulation performance across an approximately 17-fold increase in process scale, with volume accuracy of 98.2% at small scale and 103.6% at large scale.
Cell viability remained stable before and after automated formulation, indicating the process did not negatively impact cell integrity.
Cellipont Bioservices (搜索), a cell therapy Contract Development and Manufacturing Organization (CDMO), and Xiogenix (搜索), an innovator in cell and gene therapy downstream process automation, have published a new collaborative white paper titled "Scaling Cell and Gene Therapy Manufacturing with Automated Formulation and Fill-Finish." The paper presents results from Cellipont's evaluation of Xiogenix's ARES™ X20+ automated fill-finish platform, examining its performance across small and large-scale cell therapy manufacturing workflows.
As cell therapy programs advance toward larger clinical studies and commercialization, downstream formulation and fill-finish can become significant manufacturing constraints. Manual and semi-automated processes can increase variability, handling requirements, and contamination risk, making scalable, reproducible downstream processing increasingly important. The study evaluated how automation could help address these challenges while maintaining flexibility across different batch sizes, container formats, and manufacturing scales.
Key Evaluation Findings
The evaluation produced several notable results. The platform demonstrated consistent formulation performance across an approximately 17-fold increase in process scale. Final formulation volume accuracy measured 98.2% at small scale and 103.6% at large scale. Importantly, cell viability remained stable before and after automated formulation, indicating the process did not negatively impact cell integrity.
"These findings are important because scaling cell therapy manufacturing is not simply about producing more cells — the entire manufacturing process has to scale with the therapy," said Darren Head, Chief Executive Officer of Cellipont Bioservices (搜索). "As programs advance, downstream formulation and fill-finish become increasingly important to consistency, throughput and manufacturing readiness."
Platform Enhancements
The evaluation also provided practical feedback used to implement next-generation enhancements to the ARES™ X20+ platform. These improvements included refinements in priming, single-use kit capacity, pressure integrity monitoring, gravimetric control, pump calibration, and product recovery.
"The most meaningful innovation doesn't happen in isolation, it happens when we work side by side with our customers to understand the challenges they are trying to solve," said Rachel Bahr, Chief Executive Officer of Xiogenix (搜索). "Our collaboration with Cellipont is a great example of that approach. Together, we demonstrated the potential of automation to bring greater consistency and flexibility as cell therapy manufacturing scales, while also identifying opportunities to make the ARES™ X20+ even better. Ultimately, our goal is to build solutions that grow with our customers and help remove manufacturing barriers as therapies move toward commercialization."
Industry Engagement
Cellipont Bioservices (搜索) will attend the 11th CAR-TCR Summit, September 15–17, 2026, in Boston, where automated manufacturing and the scalability of next-generation cell therapies will be among the key topics discussed across the industry. Xiogenix (搜索) brings more than 25 years of experience in regulated biologics and more than 250 systems deployed internationally to its portfolio of automated formulation and fill-finish systems, tissue processing technologies, and single-use systems.