
CMC: Focus on Providing a Fully Integrated CMC Design and Implementation Strategy.
The chemistry, manufacturing, and control (CMC) group at Chorus is primarily focused on providing a fully integrated CMC design and implementation strategy to support pre-clinical, first human studies and early proof of concept (PoC) clinical testing.
The chemistry, manufacturing, and control (CMC) group at Chorus is primarily focused on providing a fully integrated CMC design and implementation strategy to support pre-clinical, first human studies and early proof of concept (PoC) clinical testing.
- pre-formulation;
- biopharmaceutics;
- drug substance process development and manufacturing;
- drug product formulation development and manufacturing;
- analytical control;
- packaging, labeling, and release of clinical material;
- clinical distribution; and
- ongoing CMC support throughout the clinical phases
Consistent with the overall Chorus model, emphasis is placed on conducting the minimally required CMC work necessary to allow the key toxicology and clinical experiments to be conducted while deferring all later phase parallel processing until the PoC has been demonstrated.
