Risk Management Across The Cell Therapy Lifecycle: Guiding Principles For Process Development And IND Readiness

Developing cell therapies requires more than scientific innovation; it demands precise coordination, risk-aware planning, and long-term vision. From early candidate selection through to IND readiness and commercialization, each decision has ripple effects across the development lifecycle. Should you prioritize speed to clinic or build a scalable, commercial-ready process from the start? These early choices often determine whether a therapy is successful or not.

Explore a structured, milestone-based approach to managing risk throughout cell therapy development, while also leveraging design of experiments (DoEs), implementing phase-appropriate analytical control strategies, and deciding between parallel or sequential process evaluations to streamline progression toward clinical trials. With considerations for scaling and technology transfer, ensure your therapy is not only safe and effective, but also manufacturable and regulatory-ready.

Whether you're planning your first IND or refining your commercial strategy, this roadmap provides critical insights to reduce uncertainty, save time, and optimize your path forward. Discover how innovative risk management and strategic CDMO partnerships can accelerate your cell therapy from lab to launch.