The Challenge of Scaling Cell and Gene Therapy

Erik Vaessen on the costs, complexities, and technologies shaping advanced therapy manufacturing.

1

High costs, complex workflows, specialized labor, and biological variability make consistent, large-scale cell and gene therapy manufacturing difficult.
2

Developers increasingly prioritize scalability, manufacturability, supply chain robustness, and commercial viability earlier in development.
3

Technology transfer, reproducibility, operator training, raw material variability, documentation, and GMP execution complicate the move to commercial manufacturing.
4

Advances in cell culture media and process development can improve cell growth, productivity, and consistency across production scales.
5

Automation, reliable supplies, and emerging in vivo approaches such as CAR-T and self-amplifying RNA may shape future manufacturing strategies.

1