Outsourcing-Pharma.com: Quality-by-design: How to mitigate risk in drug development

By Melissa Fassbender

Published online at Outsourcing-Pharma.com, Nov. 2017.

Joe DiMartino, solution manager, Luminata, at ACD/Labs speaks to Outsourcing-Pharma.com at AAPS 2017 in San Diego, CA, about the evolving regulatory landscape and how companies can leverage QbD to help mitigate risk in drug development.

Luminata from ACD/Labs is a unique informatics solution for the management of process and impurity data with unparalleled functionality and benefits for development organizations. Luminata unifies and assembles the overwhelming quantity of analytical and chemical data, routinely generated in drug development, in real time.

Built on the multi-technique, vendor-agnostic ACD/Spectrus Platform; Luminata offers comprehensive data standardization—accomplished by aggregating chemical reaction information, and the associated formation and fate of impurities, with chromatographic and spectral data. It facilitates efficient organization of analytical knowledge for processes and associated impurities, at every stage.