Gabriella Dahlgren, PhD

Janssen Supply Group LLC
Senior Manager, Strategy Deployment and Excellence, PQM
Gabriella Dahlgren, PhD, oversees a team that manages stability for the Janssen SM portfolio. She has been part of the Global Janssen Product Quality organization since 2015, initially focused on leading the development of new procedures and processes to support PAT, real-time release, and CM. She is currently Co-Lead of the ISPE PQLI® Continuous Manufacturing team. Prior to joining Janssen, Gabriella’s experiences included more than 10 years as an analytical chemist in various functions, focused on end-to-end process creation for method development, test method validation, new technology eval-uation to speed up release testing, and hydrophilic coating implementation on new medical devices. She also served as the cross-functional subject matter expert for resolution of production issues as they relate to testing and chemical characterization. She has a PhD in bioanalytical chemistry from the University of Michigan and a BS in chemistry from Southeastern Louisiana University. She has been an ISPE member since 2015.

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  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Tripartite Guideline Q13: Continuous Manufacturing of Drug Substances and Drug Products.” Published July 2021.

The creation of a new ICH guidance document, Q13, presents an opportunity for industry and regulators around the world to connect and develop harmonized regulatory expectations for the continuous manufacturing (CM) of drug substances and drug products, resulting in an increased likelihood of implementation across the globe.

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Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and regulatory hurdles in the life cycle of a process analytical technology application—including model...