How to navigate in vivo CAR-T development and overcoming CMC hurdles.

Cell and gene therapies (CGT) are transforming disease treatment, with CAR-T therapies facing challenges like high costs and long production times. In vivo CAR-T offers a breakthrough by engineering immune cells directly inside the body, bypassing complex manufacturing. Using viral vectors like lentivirus (LVV) or non-viral carriers like lipid nanoparticles (tLNPs), this method enables more scalable, accessible, and timely treatment.

As this field rapidly evolves, speed to IIT or IND is critical to competitiveness, yet CMC challenges can significantly slow progress. This presentation explores those CMC hurdles and the solutions that can accelerate in vivo CAR‑T discovery and development.