Newsletter | August 15, 2018

08.15.18 -- Have You Considered These Strategies For The Success Of Your Complex Molecule?

New Tufts Study Uncovers The Economic Advantage Of Single-Source Drug Development And Manufacturing
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.
Characterize Drug Substance Properties Early To Optimize Drug Formulation
By Anil Kane
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.
Accelerate Complex Molecule Development By Optimizing Chemical Synthesis And Formulation
By Andreas Stolle and Peter Poechlauer
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.
8 Criteria For A More Successful API Partnership
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.