The development and manufacturing of innovative drug products, particularly those involving protein formulations, nucleotide-based drugs, peptides, and poorly soluble molecules, face significant hurdles. A primary challenge lies in designing scalable manufacturing processes that meet production demands while ensuring stability and bioavailability. Traditional methods often fall short when handling advanced therapeutic modalities, resulting in limitations in production volume, product consistency, and manufacturability. Addressing these limitations is critical to bringing novel therapies to market effectively and at scale. Spray drying has emerged as a scalable and consistent manufacturing process for producing drug product intermediates. This paper explores the use of spray drying to overcome manufacturing bottlenecks and enhance development across a wide range of drug products.
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.