Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them before agency filing.

Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.

Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.

Jaenisch, Muraru, and Pandey discuss how regulators will audit pharma against its own AI policies and ways QA and regulatory teams can build defensible, inspection-ready AI practices.

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.

Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.

CPHI Award winner, Pauline van der Wijst-Janssen, PhD, product development manager and global technical lead at DFE Pharma, explains excipient variability and excipients’ role in continuous manufacturing.

Pauline van der Wijst-Janssen, PhD, of DFE Pharma, won the CPHI Pharma Award for Future Leader. In this interview with PharmTech, she provides advice for scientists looking to advance to leadership roles.