Monolith-based Analytical Solutions for Optimizing and Scaling USP AAV Process

MSS2026

1.) Course Description

This hands-on training session will demonstrate the application of advanced analytics for the characterization of challenging USP samples, including crude harvests and lysates. Participants will gain valuable insights into the benefits of sample purification using CIM SO3 96-well monolith plates, with direct applications in Mass Photometry (MP) and Capillary Gel Electrophoresis (CGE). Additionally, we will provide hands-on experience of the innovative PATfix AAV Switcher E/F separation, analysed directly from harvests obtained through our scale-up production process using the AMBR250 system.

2.) Who Should Attend?

◾︎ USP process development
◾︎ Process development
◾︎ R&D
◾︎ QA and analytical development

3.) Key Learnings

◾︎ Overcoming USP Scale-Up Challenges with Advanced Analytical Techniques: Learn how to effectively address the complexities of scaling up USP processes by utilising new analytical approaches that enhance precision and efficiency.
◾︎ Characterisation of Harvest Sample Empty/Full Ratio: Gain insights into the direct determination of the empty/full ratio in harvest samples using the PATfix AAV Switcher, with CIMTrap and QA HR monolith columns, ensuring fast, accurate and reliable results.
◾︎Improve Strategies for Successful USP Sample Preparation: Discover crucial points for preparing USP samples for sensitive analytical methods, utilizing CIM SO3 96-well monolith plates to optimize sample integrity and analytical outcomes.
◾︎ Hands-On Demonstration of USP Sample Analytics: Observe practical aspects of USP samples characterisation analytics, using Mass Photometry (MP) and Capillary Gel Electrophoresis (CGE), to help with the production process improvement