Emerging Technologies For Cell Therapy Manufacturing
By Erin Harris, Editor-In-Chief, Cell & Gene
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During last month’s Cell & Gene Live, Emerging Technologies for Cell Therapy Manufacturing, I had the pleasure of conversing with our expert panelists, Rohit Ingale, Head of Manufacturing & MSAT at Arcellx and David O’Donnell, Vice President, Head of Manufacturing at Vor Bio about the biggest challenges and promising innovations in cell therapy manufacturing. During the hour, Ingale and O’Donnell covered how the complexity of autologous and hybrid models demand change to improve scalability, reduce costs, and ultimately enhance patient access.
Current Challenges in Cell Therapy Manufacturing
Ingale opened the discussion by addressing some of the most significant hurdles in the current manufacturing process. Chief among them is the vein-to-vein period from a patient’s cell collection to infusion of the final product, which can span weeks or even months. This delay is especially critical for patients with aggressive diseases.
Another key issue is the reliance on manual operations. Despite attempts to automate, many processes still reflect their academic roots, involving significant hands-on work. Ingale estimated that up to 200 man-hours may go into a single therapy, accounting for more than half the total manufacturing cost. This manual burden increases variability and raises the risk of human error, impacting product consistency and making scalability a daunting challenge.
Patient-to-patient variability and differences in raw materials further complicate the process. Even with defined manufacturing platforms, the unique biological profile of each patient or donor introduces unpredictability. Compounding this are batch failures, which occur in 10–20% of cases, often due to unmet release specifications or inadequate final dose — outcomes that prevent patients from receiving potentially life-saving therapies.
O'Donnell echoed these concerns and framed the process as a complex puzzle — one requiring precision at every step from collection through to logistics. He emphasized the ongoing tension between the need for speed and the need for robustness. With pressure to accelerate development and meet investor expectations, companies often have limited time for refining manufacturing, analytics, and logistics.
Both panelists agreed that manufacturability must be considered early in development. Treating manufacturing as a marathon rather than a series of sprints, as O’Donnell suggested, allows for a more sustainable path to the market.
The Emerging Technologies Shaping the Future in Cell Therapy Manufacturing
When the discussion turned to innovation, Ingale offered a pragmatic definition: innovation is any solution that ultimately benefits the patient. He shared that for him, automation and robotics are at the heart of the next wave of change in cell therapy manufacturing. Today’s processes remain largely “handcrafted,” with significant manual involvement in operations such as isolation, transduction, and formulation. While some platforms have integrated these functions, they often dedicate equipment to individual patients, limiting throughput.
Looking ahead, Ingale sees the move toward high-throughput manufacturing, potentially via a “GMP-in-a-box” concept, as key to scaling efficiently. Robotics, especially when paired with AI and machine learning, could transform how therapies are produced. Tasks like cell manipulation, mixing, and sample transfers, currently done by technicians, can be replicated by robotic systems, improving consistency and reducing human error.
Advanced analytics also play a vital role. By aggregating data across supply chains, manufacturing operations, and patient outcomes, AI can provide predictive insights and help manufacturers preempt issues. Ingale believes these capabilities could disrupt the industry as profoundly as robotics.
O’Donnell emphasized that many current manufacturing workflows originated from manual techniques. True innovation will require creating processes tailored to the biology of cells, not the constraints of existing systems. He noted the promise of efficient genome editing tools and emphasized the importance of choosing the right moment to invest in emerging technologies. For small biotech companies, early investment in automation may be ideal but financially unrealistic. Modular implementation — starting small and building over time — offers a practical approach.
O’Donnell also highlighted the value of real-time analytics for measuring key cell parameters. Coupled with AI, these tools can enable adaptive manufacturing and quick troubleshooting. Ingale added that while ambitious, automation initiatives should be grounded in clear, patient-centric goals.
The Earlier the Better for Scalability and Strategic Planning
Scalability remains a critical hurdle in bringing cell therapies from bench to bedside. O’Donnell explained the distinction between autologous and allogeneic models: the former requires scaling out (more parallel processes per patient), while the latter focuses on scaling up cell yields. Both approaches pose biological and logistical challenges.
For successful scale-up, O’Donnell underscored the importance of process stability. Automation should align with a well-defined, stable workflow; introducing it too early in an evolving process can lead to costly setbacks. As such, he advised companies to define their “end game” early, knowing the final commercial goal can guide decisions throughout development.
Ingale reinforced this point, advocating for early involvement of manufacturing, analytical, and QC teams even in phase one trials. This cross-functional collaboration allows for manufacturability assessments that can streamline later stages and avoid costly re-work.
Improving the Patient Experience is Always the Goal
The goal, both panelists emphasized, is improving the patient experience. Reducing vein-to-vein time is crucial, especially for cancer patients with limited treatment windows. Ingale noted that minimizing quality control times and enabling predictable scheduling are key to ensuring therapies are available when needed.
O’Donnell explored the potential of decentralized manufacturing to reduce logistical burdens. Bringing production closer to patients could improve access, particularly in community settings where most patients receive care. Emerging strategies such as earlier infusion, rapid in vivo expansion, and standardized delivery protocols could also broaden accessibility.
The Role of Digital Tools: The Time to Digitize is Now
Digital integration is another area of focus. O’Donnell recommended early implementation of systems like MES, LIMS, and ERP to manage the vast datasets generated throughout the therapy lifecycle. These tools can help identify critical variables and inform both process optimization and regulatory submissions.
Ingale stressed that the time to digitize is now. He highlighted the benefits of no-code MES solutions for managing electronic batch records and emphasized that structured, digital data lays the groundwork for future efficiencies. However, he cautioned that digital efforts should always support, not delay, the core mission of delivering therapy to patients.
Final Thoughts from the Cell Therapy Manufacturing Experts
Ingale and O’Donnell agreed that automation, robotics, AI, and digital tools offer a clear path to scalable, efficient, and patient-centric manufacturing. But success requires more than adopting new technologies; it demands early planning, cross-functional collaboration, and a steadfast focus on the patient.
If you would like to watch this important and engaging conversation, the full version is available on demand. And, as always, if you have questions about this discussion or any other Cell & Gene Live event, please feel free to reach out to me directly.