From Research To Reality: Designing Scalable Cell Therapy For Successful Development

Only 49 cell and gene therapies have reached commercial approval despite more than 5,000 active clinical trials. The gap is largely operational: biological variability, process inconsistency, and manual manufacturing workflows prevent reproducible translation at scale.

This presentation explains that the choices you make in early research, including raw material selection, media formulation, and process design, directly determine lot variability risk, scalability constraints, and downstream regulatory burden. Transitioning from serum-containing to chemically defined, xeno-free media reduces a key source of process variability. Closed, automated platforms eliminate operator-driven inconsistency and reduce cleanroom grade requirements from A/B to D. Modular workflow design with defined critical quality attributes at each step positions your process for GMP compliance before phase transitions, not after.

Access the full presentation to learn how to align your early-stage decisions with commercial-scale manufacturing requirements.