How To Develop A Cell Therapy Manufacturing Roadmap

A good manufacturing roadmap provides flexible guidelines to advance automation. It’s a living document and will be refined many times as manufacturing needs and processes evolve.

The roadmap should first be implemented during the preclinical phase to encompass the complete journey. The destination is full commercialization, and each manufacturer must understand how to get there.

Cell and gene therapy (CGT) manufacturers must review the technology landscape to understand their choices. For example, they may need an instrument that does not actually exist and will have to decide whether it is more cost-effective to build it from scratch or find another option.

The key is mapping out the entire process and developing a clear understanding of what needs to be done and when. Here are the key questions to ask when building a manufacturing roadmap.