Designing A Product That Lasts
At the root of any CMC work are the proper definition and physicochemical properties of the molecule, both the drug substance/API and the drug product. An understanding of the critical properties of the molecule leads to the definition of critical quality attributes and specifications. These will be further refined during development, but this knowledge underlies all other CMC work.
To accurately measure different critical aspects of the molecule, it is necessary to develop analytical methods. These are often specific to each project and molecule and during development will go from qualified status to being fully validated.