When Should You Engage A Cell And Gene Therapy CDMO? Earlier Than You Think

By Yogesh Waghmare, Senior Director, MSAT

Waiting to involve contract development and manufacturing partners until a cell or gene therapy process is finalized often introduces hidden operational bottlenecks. When technical teams finalize protocols strictly on the lab bench, critical factors—such as equipment reliability, raw material vendor stability, and phase-dependent processing times—go unaddressed until tech transfer begins. Initiating partner collaboration while process development decisions remain fluid allows real-world manufacturing expertise to shape the design from the ground up. This proactive alignment eliminates costly rework, prevents unexpected failures during clinical batch runs, and establishes a seamless bridge between early-stage innovation and commercial scale.

Discover how early process design collaboration de-risks tech transfer and safeguards program momentum.