Director of Pharmaceutical Science digiM Solution Woburn, Massachusetts
With the advent of next generation therapies and targeted drug platforms, understanding how the product changes with each processing step has become critical for rapid and cost-efficient development. New characterization methods that can be used to tie together formulation and manufacturing conditions with downstream in vitro and in vivo pharmacokinetic performance have become necessary for these novel platforms. We present here synchrotron-based X-ray imaging as the new premier non-invasive and non-destructive imaging tool for drug product characterization. The vast resolution range from tens of nanometers to tens of microns per pixel, combined with the high photon flux make synchrotron imaging unparalleled in image quality and image acquisition. The utility of synchrotron imaging across different dosage forms such as controlled release platforms, injectables, oral solid dosage, and lyophilized solids is shown. Combined with artificial intelligence-based analysis, synchrotron imaging is the most cutting-edge tool to accelerate drug product development.
Learning Objectives:
Upon completion, participants will be able to leverage synchrotron-based X-ray imaging to characterize their formulations across the different product stages, and accelerate their product development.
Upon completion, participants will be able to improve their product knowledge through non-invasive characterization over a broad range of size scales using synchrotron-based X-ray imaging
Upon completion, participants will be able to explore manufacturing design choices though strucuteral imaging using synchrotorn-based X-ray imaging