Maximizing Impact in Cell Therapy Manufacturing: How Single-Use and Closed Systems Work Better Together

It is becoming standard for cell and gene therapy CDMOs to offer both SUTs and closed systems for use in manufacturing processes. This combination doesn’t just improve efficiency. It also helps de-risk the clinical path — a big deal when timelines are tight.

Beyond technical advantages it also provides greater confidence in the CDMO’s ability to maintain sterility and product quality—critical in early-phase trials where every dose counts.

There are several ways sponsors can benefit from partnering with a CDMO that offers these technologies:

1.      Enhanced Contamination Control

Sterility is critical in cell therapy manufacturing, especially for autologous therapies where there is no second batch of patient material available and time is of the essence. When single-use components are integrated into a closed system, sterility assurance is maximized — both by removing opportunities for environmental exposure and by eliminating cleaning steps that can introduce risk. This allows for safer, more reliable manufacturing — particularly important for early-phase and patient-specific products.

2.      Improved Flexibility and Scalability

Cell therapy processes often need to accommodate different product types, batch sizes, and production schedules. Because SUT assemblies can be swapped in and out within closed devices, production lines can rapidly adapt to changing product types or scale requirements without compromising containment. This makes it easy to switch between products or scale from clinical to commercial production. Choosing a closed system device also provides sponsors with the option for a seamless transition to point-of-care manufacturing at commercial stage without needing to adjust processes.

3.      Ensuring Process Consistency

Consistency is critical in cell therapy manufacturing — especially as processes move from early-phase trials to commercial production. When single-use assemblies are built into closed systems, every step can be replicated with the same equipment, materials, and environmental controls, regardless of production site. This minimizes variability, supports comparability studies, and reduces the risk of needing costly process changes later.

Sponsors can benefit from selecting a CDMO that offers the same closed-system devices that they are already using in their preclinical processes, thus ensuring swifter technology transfer and process consistency. Some CDMOs offer proprietary devices, so Sponsors should work with legal counsel to evaluate any potential impact on their manufacturing strategy. Once a method is established in Phase I/II, changing it while maintaining regulatory status can be challenging, making early alignment even more important.

4.      Regulatory and Quality Readiness

While regulators don’t mandate closed systems for every process, in practice, they increasingly expect to see risk-based contamination strategies. Closed systems can significantly reduce risk of contamination by minimizing manual interventions. Incorporating single-use within closed systems reduces the need for cleaning & validation records while simplifying regulatory inspections. They support compliance with GMP guidelines by reducing bioburden, improving traceability, and enabling better control over critical process parameters. Additionally, the disposability of SUTs reduces cleaning-related deviations and simplifies batch records, supporting more straightforward audits and inspections.