Development of novel small molecule active pharmaceutical ingredients (APIs) is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. With hundreds of potential partners that drug owners can choose from to develop and manufacture small molecule APIs, choosing the best partner can be a challenging task. In this white paper, we explore the importance of purposefully aligning the overall drug development strategy with a partnering strategy. We also review how increasing development of novel drugs are also impacting the industry’s go-to-market efforts, driving new demand for expert small molecule API suppliers. Finally, we consider how small molecule API development projects can be executed by leveraging the experience of embedded contract development and manufacturing (CDMO) partners.
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.