Fly me to the MARS: Multi-attribute Raman Spectroscopy

Description:
Rapid release of biopharmaceutical products enables a more efficient drug manufacturing process. Multi-attribute methods that target several product quality attributes (PQAs) at one time are an essential pillar of the rapid-release strategy. The novel, high-throughput, and nondestructive multi-attribute Raman spectroscopy (MARS) method combines Raman spectroscopy, design of experiments, and multivariate data analysis (MVDA). MARS allows the measurement of multiple PQAs for formulated protein therapeutics without sample preparation from a single spectroscopic scan. Variable importance in projection analysis is used to associate the chemical and spectral basis of targeted PQAs, which assists in model interpretation and selection. In this presentation, we demonstrate the feasibility of MARS for the measurement of both protein purity-related and formulation-related PQAs; measurements of protein concentration, osmolality, and some formulation additives were achieved by a generic multiproduct model for various protein products containing the same formulation components. MARS demonstrates the potential to be a powerful methodology to improve the efficiency of biopharmaceutical development and manufacturing, as it features fast turnaround time, good robustness, less human intervention, and potential for automation.

Speaker: Bingchuan Wei - Genentech
Bingchuan is a Senior Principal Scientist from the Small Molecule Analytical Chemistry department. He joined Genentech and started at in 2014 after postdoc research at University of Washington and Purdue University. Bingchuan has led and contributed to the analytical development of pipeline projects with various modalities including as well as several innovation initiatives such as multi-attribute Raman spectroscopy and real-time release testing. Bingchuan received his PhD in analytical chemistry from Purdue University and B.S. in chemistry and mathematics from Peking University. He also holds his MBA degree in business analysis from Penn State University in 2021.