Merck and Agilent Collaboration
Integration of On-line High Performance Liquid Chromatography (HPLC) as a Process Analytical Technology (PAT) tool for Critical Quality Attribute (CQA) Monitoring and Control
Merck and Agilent technologies are partnering to demonstrate how direct access to on-line high-performance liquid chromatography (HPLC) data can empower advanced process control. The implementation of HPLC as a process analytical technology (PAT) tool facilitates a Dynamic Manufacturing Process that can compensate for variability in raw materials and equipment. Quality is therefore built into the process by design.
As an initial use case, the Agilent 1260 Infinity II Prime Online LC system will be implemented as an on-line PAT tool to monitor aggregate levels after flow-through frontal chromatography using Eshmuno® CP-FT resin. Upon detection of aggregates in the column effluent, automated column switching will be initiated in order to ensure effective and efficient continuous removal of aggregates. Read the full press release here.
The implementation of PAT along the bioprocess workstream is a key enabler of continuous manufacturing and empowers progress towards the Facility of the Future.
Eshmuno® CP-FT Resin |
Agilent 1260 Infinity II Prime Online LC System |
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Eshmuno® CP‑FT cation exchange (CEX) resin is specifically designed to provide efficient removal of mAb aggregates in the flow- through frontal chromatography mode of operation enabling loading capacities 10× higher than traditional bind/elute CEX chromatography. Eshmuno® CP‑FT resin facilitates greater manufacturing flexibility and process intensification while reducing the overall cost for the downstream purification of mAbs. |
The 1260 Infinity II Prime Online LC System is a process analysis system enabling automated process monitoring and providing real- time data for greater control and faster understanding of critical quality attributes, as well as critical process parameters. Supporting the needs of scientists using process analytical technology in the pharmaceutical industry, the real-time monitoring LC instrument supports direct injections for fast process monitoring. This process analysis system also features retain-sample functionality for dilutions or automated sample preparation steps, multimethod analysis, or sample archiving purposes for offline quality control. |
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