With patient care at the forefront, it is critical to assess the economics of both outsourcing models and ensure that the one you select provides the most efficient path to commercialization. This was the purpose of a recent study by the Tufts Center for the Study of Drug Development (CSDD), which compared cycle times and development economics between multi- and single-source CDMO models.
Molecules continue to get more challenging from the perspective of solubility, bioavailability, and exposure. Establishing effective communications between DS chemists and DP formulators manages the risks and maximizes the rewards of transforming less soluble and less bioavailable molecules into effective new drugs.
Finding a balance between a complex API, its formulation, and its synthesis requires equipment, knowledge, and processes more extensive than those typically required for traditional drug development. It also calls for collaboration across several teams in order to break down the silos that can interrupt the flow of open and clear communication.
Outsourcing API development can save time and money. Or it can waste them. Since the difference between these outcomes stems from your choice of a development partner, careful consideration of these eight critical areas is required to help ensure a fast, smooth API development process.