Cell and gene therapies are rapidly transforming healthcare, offering promising new treatments for a range of serious conditions. However, scaling these therapies from early-stage development to commercial production presents significant challenges.
At the recent Bioprocessing Summit in Boston, Todd Martensen, Chief Commercial Officer of Ascential Medical & Life Sciences, shared valuable insights with life sciences blogger Rizwan Chaudhrey of #LiveWithChaudhrey. The discussion ranged from the complexities of scaling up cell and gene therapy manufacturing to how companies can navigate this evolving field.
An Evolving Landscape
The cell and gene therapy market is expanding at an unprecedented pace, driven by advances in biotechnology and increasing clinical success. However, scaling these therapies from research to full-scale production involves unique challenges that differ significantly from traditional biologics manufacturing. According to Martensen, “The complexity of manufacturing with living cells and tailored treatments requires a whole new level of precision and control to ensure consistency and compliance at scale.”
At the summit, several experts highlighted that data science and digital twins are becoming pivotal in achieving these goals. For example, digital twins can help model bioprocess workflows, allowing companies to optimize manufacturing before moving to full-scale production. This strategy helps mitigate risks by simulating different production scenarios and identifying potential bottlenecks early in the development process.
Addressing Challenges Across the Product Lifecycle
Scaling up the production of cell and gene therapies requires a strategic approach that considers every stage of the product lifecycle—from early R&D through to commercial manufacturing. Each stage presents distinct hurdles, including process development, quality control, regulatory compliance, and cost management. “By working with a partner who can provide end-to-end support—from concept through commercialization—companies can navigate these hurdles with greater confidence and agility,” Martensen said.
This holistic view was echoed at the summit, where experts discussed the importance of a seamless handover between development stages. For example, efficient data management practices across the lifecycle not only ensure regulatory compliance but also minimize Chemistry, Manufacturing, and Controls (CMC) challenges.
The Role of Automation
Automation plays a critical role in scaling cell and gene therapies, especially as companies look to meet growing demand while maintaining high-quality standards. Automated systems help streamline production processes, reduce manual errors, and ensure the reproducibility needed for clinical success. For complex applications where precision and consistency are key, integrating automation into the manufacturing process is essential.
At the summit, several sessions highlighted how advancements in smart sensors, process analytical technology (PAT), and predictive modeling can transform manufacturing efficiency. By leveraging these innovations, companies can achieve high-throughput production and ensure that life-saving medicines reach patients reliably and at scale. Martensen reinforced this point in his video interview, saying, “Automation doesn’t just speed up production; it builds reliability and traceability into every step, which is crucial for meeting the exacting standards of cell and gene therapies.”
The Expanding Ecosystem
As the cell and gene therapy field evolves, a collaborative approach to scaling production is becoming increasingly important. Partnerships between pharmaceutical companies, contract development and manufacturing organizations (CDMOs), and technology providers can help streamline the process of bringing new therapies to market. These collaborations enable the sharing of specialized knowledge and resources, accelerating the development of innovative solutions.
For example, companies can reduce material costs and increase speed at early development stages, then shift to more robust, scalable processes for commercial production. This collaborative, ecosystem-driven approach allows companies to meet evolving market demands and regulatory requirements effectively.
Preparing for the Future
Looking ahead, the ability to scale cell and gene therapies will depend not only on technical capabilities but also on the ability to adapt to the rapidly changing regulatory landscape and evolving market demands. As Martensen noted, “The future of cell and gene therapy will be shaped by those who can anticipate and address these complexities—not just from a technical standpoint but from a strategic, holistic perspective.”