The Role of Chemical Development and Drug Substance Manufacturing in Early Integrated CMC Development at Emerging and Virtual Pharma

摘要

Integrated chemistry, manufacturing and controls (CMC) development views the entire effort to develop and supply a drug's dosage form holistically. While there are certainly distinctions between the activities contributing to pharmaceutical development and drug supply, an integrated approach looks for overlap, synergies and dependencies between activities. This approach proceeds with an awareness of the interdependency of component activities, as well as cognizance of activities outside of the realm of CMC that impact and are impacted by CMC strategy. A drug candidate's molecular properties determine options for preclinical and clinical dosing. However, preclinical and clinical data, once obtained, also drive changes in a drug's formulation, which can necessitate an adjustment of the physical form of the active pharmaceutical ingredient (API).