From promise to patients: Smarter pathways to scale in cell and gene therapy manufacturing

Bridging the translation gap

Early-stage programs often begin with manual, research-driven processes that do not translate directly into compliant manufacturing environments. These gaps create risks of inconsistency, higher costs, and significant delays.

Key challenges such as limited funding, process variability, and evolving regulatory expectations continue to slow progress from early discovery to commercialization.

Translational research services help address these gaps by assessing workflows early on for steps that might compromise scalability. Translational research teams then produce small-scale viral vector and cell therapy materials using scaled-down processes that mirror cGMP. This “start-with-the-end-in-mind” approach establishes standardized methods and qualifiable assays early, reducing risk during the transition to GMP manufacturing.

At this stage, structured approaches also play an important role. By combining standardized process elements with the flexibility needed for novel therapies, they create a stronger foundation for advancing more predictably from bench to bedside.
 

Automating for scalable cell and gene therapy manufacturing

Automation has become central to the conversation on scale-up, but the key question is where it provides the most value. The highest priorities are steps that are labor-intensive, prone to variability, or create bottlenecks in throughput.

Applying fit-for-purpose technologies tailored to the biology, product format, and scale can deliver meaningful gains in consistency, efficiency, and throughput. Parallel processing across patient or donor batches is one example of how automation can reduce variability and improve reliability.

Automation also extends to analytical workflows. Real-time monitoring and data integration help reduce variability, strengthen quality systems, and provide developers with the confidence needed to make decisions during therapy development. Focusing automation where it adds the most benefit accelerates progress while minimizing regulatory and rework risk.
 

Balancing structure and adaptability

Traditional platform processes can accelerate development, but their rigidity often limits innovation. What’s needed are frameworks for cell and gene therapy that combine the efficiency of standardized methods with the flexibility required for novel therapies. This includes options for automation, different reprogramming or delivery methods, and established assays such as flow cytometry, ddPCR, and potency testing.

Ultimately, this balance helps ensure that innovative therapies can reach patients more reliably and at scale.
 

Designing scalable, compliant processes from the start

Processes designed with scalability and compliance in mind from the outset avoid the costly rework that can derail development timelines. Proactive strategies, such as embedding quality-by-design principles, leveraging standardized frameworks, and anticipating regulatory requirements, support smoother progression.

We’ve seen this in CAR-T development, where an integrated framework allows customers to move from process design to GMP manufacturing in a fraction of the typical timeline, saving months and significant costs. Similarly, in gene editing, the ability to customize workflows within a standardized backbone provides customers with the flexibility they need without sacrificing consistency across sites.
 

Collaboration as the multiplier

Even in times of uncertainty, innovation often advances through collaboration. For cell therapy developers, the most effective supplier partnerships are those that help reduce complexity and connect the many moving parts of development and manufacturing.

Effective collaboration spans the entire journey, from research tools and process development to GMP manufacturing, supply chain logistics, and regulatory guidance. The value lies in comprehensive integration of CDMO, CRO, and clinical supply solutions that reduce handoffs, streamline tech transfer, and enable consistency across phases and geographies.
 

Looking ahead

The future of cell and gene therapy will be shaped not only by scientific advances but also by the strategies adopted to bring them to scale. Purposeful automation, adaptable solutions, translational alignment, and integrated models will play a defining role.

For developers, building with the end in mind and working with partners that provide both flexibility and infrastructure will be critical. For CDMOs, the responsibility is to go beyond manufacturing capacity and deliver integrated solutions that reduce risk and accelerate delivery.

More intentional and connected pathways will define the future of cell and gene therapy, ultimately shaping how innovations move from discovery to widespread patient availability.