Real Time Online Chromatography Monitoring of Product Quality Attributes for Biologics Continuous Manufacturing Process


28th February 2019 | 10AM EST / 3PM GMT / 4PM CET | Gang Xue, Scientific Director at Amgen Inc. |BOOK FREE SEAT

The ever diversifying therapeutic modalities drive for modular and flexible bio-manufacturing, which transformed the biologics process from traditional Fed-batch to Single Use BioReactor (SUB), then to Continuous Manufacturing (CM). Process Analytics evolve as a critical enabling element of the CM process. It allows to move the release testing from the end of the process to real time in the process, which not only eliminates weeks of material disposition delay, but also provides the process scientists product quality insight during the run to make process decisions. However, due to the structural complexity of the bio-molecules, spectroscopic sensors or probes nowadays lack the sensitivity and specificity to illustrate the product quality attributes (PQA) such as protein post-translational modifications (PTM). We report here for the first time, we leverage a multi-functional automation system to directly take samples from the different stage of bio-process, purify, denature, derivatize and digest the samples before injecting onto the UHPLC and UHPLC/MS systems, one for online intact protein analysis, the other for Multiple Attribute Method (MAM) analysis for critical PTM PQAs. Benefiting from the high resolution chromatography and mass spectrometry, automated real time bio-molecule product quality monitoring is achieved for both SUB and CM process.

Presented by Gang Xue, Scientific Director at Amgen Inc.

Dr Gang Xue is a Scientific Director at Amgen Inc. located in Cambridge, MA. With B.S. degree in Chemistry and B.E. in Computer Science from Tsinghua University and PhD in Analytical Chemistry from the Iowa State University, Gang is currently leading the Process Analytics group within Amgen Process Development organization. One of his group’s focuses is the cross modality PAT strategy for the biologics and synthetic continuous manufacturing with the goal of process control and real-time release testing (RtRT). The other responsibility is the design and implementation of lab informatics ecosystem for Process Development labs and plants focusing on holistic scientific data capture and aggregation in Cloud based Enterprise Data Lake. He also is one of the founding members of Allotrope Foundation. Prior to his current role, Gang worked at Pfizer as Associate Research Fellow with 11 years of experience in Analytical Development.

 


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