Process Development to GMP Implementation of Raman Spectroscopy as a PAT Tool for the Purification of Protein Based Therapeutics

Regeneron Pharmaceuticals, Inc. has successfully integrated Raman Spectroscopy as a Process Analytical Technology (PAT) tool to enhance the robustness of unit operations including Ultrafiltration/Diafiltration (UF/DF) during the purification of protein-based therapeutics. This innovative approach enables real-time, in-line monitoring of critical quality attributes through universal chemometric models, streamlining the transition from process development to GMP implementation.

Presented by Christina Passno, Senior Staff Engineer, Preclinical Manufacturing & Process Development at Regeneron Pharmaceuticals

Christina Passno is a bioprocess development leader with more than 14 years at Regeneron Pharmaceuticals in Preclinical Manufacturing & Process Development (PMPD). She has held a series of roles within the Purification group and now heads the Early-Stage Purification Team, which develops, defines, and transfers purification processes for protein-based therapeutics to enable Regeneron’s First-in-Human clinical pipeline. Earlier in her career, she spent five years at Unigene Laboratories focused on peptide purification and analytical characterization. Christina holds a Bachelor of Science from Loyola University Maryland, where she completed an interdisciplinary major in Biology and Chemistry.

Followed by a live Question and Answer session