The Analytical Imperative: Why CMC Programs Are Failing in the Lab, Not the Reactor
The biopharmaceutical landscape is undergoing a seismic shift. While process scale-up and manufacturing capacity often dominate strategic discussions, the reality on the ground tells a different story. Most Chemistry, Manufacturing, and Controls (CMC) setbacks aren’t failures of engineering or bioreactors – they are failures of analytical science. In an era defined by complex biologics, cell […]