Merck announced that it has entered a collaboration with Agilent Technologies to advance Process Analytical Technologies (PAT). PAT, which is strongly encouraged by global regulatory authorities, is a key enabler for real-time release and Bioprocessing 4.0.
“The biopharmaceutical industry is on a rolling transformation to evolve and digitalize the next generation of bioprocessing to increase accessibility and lower the cost of biologics,” said Darren Verlenden, Head of BioProcessing, Life Science business sector at Merck. “By combining our advanced bioprocess portfolio with Agilent’s leading analytical solutions, we will be able to offer integrated capabilities for enhanced downstream process monitoring and control, bringing us one step closer to making the facility of the future a reality.”
With this collaboration, Merck and Agilent Technologies are filling an industry gap in downstream PAT. By combining Merck’s bioprocess portfolio with Agilent Technologies’ advanced analytical products, Merck extends real-time monitoring and automated process control of critical process parameters (CPPs) and critical quality attributes (CQAs) to downstream processing.
“Integrating analytical capabilities and intelligence into bioprocessing enables the Biopharma industry to accelerate biological drug development and manufacturing while supporting continuous manufacturing and real-time release,” said Stefan Schuette, Vice President and General Manager of Agilent´s Liquid Phase Separations Division. “This collaboration focuses on integrating Agilent’s new Online liquid chromatography (LC) solution with Merck’s bioprocessing platforms and will support customers on their journey to develop and produce biological drugs faster, with greater confidence, and at lower cost.”