MilliporeSigma and Agilent aim to extend PAT to real-time release

Merck Life Science (AKA MilliporeSigma) and Agilent Technologies have teamed up to develop process analytical technologies (PAT), citing growing drug industry demand for systems that support real-time release.

The collaboration will combine the German drug maker known as MilliporeSigma in North America and the Life Science business of Merck KGaA elsewhere bioprocessing technologies with Agilent’s analytical systems to extend “real-time monitoring and automated process control of critical process parameters (CPPs) and critical quality attributes (CQAs) to downstream processing” the firms said.

The according – financial terms of which were not disclosed – is in keeping with growing biopharmaceutical industry demand for digital manufacturing systems that make production more efficient according to Merck’s head of bioprocessing, Darren Verlenden.

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“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.

“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.”

For Stefan Schuette, vice president and general manager of Agilent´s liquid phase separations division, the project is about speeding up production processes and reducing costs.

“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.

“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.”

Digitization

The collaboration is not the first digital manufacturing agreement Merck has established in recent years.

In 2020 for example, the firm announced plans to construct a €10 million ($12 million) modular plant at its site in Darmstadt, Germany as part of a collaboration with Siemens for the digitalization of production.