Rethinking 'Platforms' In Cell And Gene Therapy Development

Platform processes have become a default assumption in cell and gene therapy development, positioned as the path to speed, standardization, and scalability. But the field’s biological complexity and program variability raise real questions about how well that premise holds in practice. While standardized approaches can create efficiencies, they can also become restrictive when programs require different materials, process parameters, or development strategies.

When predefined processes require workarounds, introduce delays, or limit the customization a program demands, the efficiency gains can erode quickly. Teams may find themselves balancing the benefits of a common platform against the need to address program-specific biology, manufacturing requirements, and evolving development goals.

This article examines the tension between structure and adaptability in CGT development, exploring where platform approaches deliver value—and where greater flexibility may be needed. It considers how a more adaptable framework can support program-specific requirements without sacrificing process control, consistency, scalability, or regulatory rigor.

Explore the full analysis to understand how teams are navigating this tradeoff and what a more flexible approach could mean for the future of CGT development.