Separation Science, in collaboration with Agilent, offers an application note demonstrating the capabilities of the Agilent Online LC Monitoring Software for automated online process control of CQAs during production and purification.
Monoclonal antibodies (mAbs) form one of the most important biopharmaceutical drug classes. A mAb is uniform on a molecular level, but during production, purification, and formulation, changes may occur that can compromise their efficacy. If you want to avoid that risk, you must control the critical quality attributes (CQAs) of an mAb during production (upstream) as well as during and after purification and formulation (downstream). This application note demonstrates the capabilities of the Agilent Online LC Monitoring Software for automated online process control of CQAs during production and purification.
What you will learn:
- How 2D-LC was used as an online LC system for process control in heart-cutting mode.
- How titer determination was performed in the first dimension, and aggregate and charge variant analysis in the second dimension.
- How the results from both dimensions were displayed in near real time.
Listen to application note author Dr Edgar Naegele discuss the key elements of this work - simply click on the image below:
Want to know more? Download your personal copy of the application note PDF by completing the form to the right.
Author & Presenter:
Dr Edgar Naegele
LC Applications Scientist, Agilent Technologies
Edgar Naegele holds a Master's degree in chemistry and a PhD in organic chemistry from the Karlsruhe Institute of Technology (KIT) in Germany. Edgar worked for different chemical and pharmaceutical companies and joined Agilent Technologies in 2001 as an application scientist for liquid chromatography (LC) and mass spectrometry (MS). He has worked on nano-LC/MS, proteomics, LC/MS metabolite ID, SFC, food LC/MS, and general LC/MS applications. Edgar is currently focused on the application of online LC in the chemical and pharmaceutical industries.