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UHPLC Analysis of Biopharmaceuticals

Learn from the experts...

In this tutorial series, you will learn the basics of (U)HPLC analysis of biotherapeutics, such as monoclonal antibodies and other proteins. We explain which critical quality attributes need to be analyzed and which (U)HPLC methods are suitable for these purposes. In addition, we provide tips and tricks from our chromatography experts for successful method development.

Tosoh_Tutorial_5_410529_80Tutorial #5: AAV Characterization by (U)HPLC – From Titer to Payload
The tutorial explains the function and structure of adeno-associated viruses (AAVs) before outlining critical quality attributes and how they are analyzed by (U)HPLC methods. These include size-exclusion chromatography (SEC) in combination with multi-angle light-scattering (MALS) and UV to determine AAV titer or payload content. In addition, it explains how ion-exchange chromatography (IEX) analyzes the full-empty ratio in AAV samples.

Tutorial_4Tutorial #4: Hydrophobic Interaction Chromatography (HIC) for Protein Analysis
Hydrophobic interaction chromatography (HIC) is an extremely versatile and powerful technique, though it is not often applied in protein analysis. This tutorial module will change that by clearly explaining how HIC works, how methods are developed, and what it can be used for.

protein_analysis_tutorial_3Tutorial #3: Glycan Analysis of Proteins and mAbs
In this tutorial, using a monoclonal antibody as an example, you will learn why glycosylation is an important parameter for the efficacy and safety of biotherapeutics and you will get to know different (U)HPLC-based methods to analyze the glycosylation pattern.

protein_analysis_tutorial_2Tutorial #2: Aggregate and Fragment Analysis with Size Exclusion Chromatography - Tips and Tricks
After shortly repeating how size exclusion chromatography works and how it analyzes aggregates and fragments of biotherapeutics, this tutorial focuses on tips to improve size exclusion separations. It covers the column choice, influences of the instrumentation and mobile phase composition.

protein_analysis_tutorial_1Tutorial #1: Protein Characteristics and How They are Analyzed
In this tutorial you will learn which characteristics in protein-based biotherapeutics need to be analyzed and why. Furthermore, you will get to know the chromatographic modes that are employed to analyze these (critical) quality attributes and how they work.

The Expert
AndreaKrumm_200These tutorials are brought to you in collaboration with Tosoh, and presented by Andrea Krumm. Andrea studied biotechnology before gaining a PhD in cancer biology. After four years as an applications specialist for optical analytical devices used in life science research, she joined Tosoh Bioscience GmbH in 2020 as a product manager for analytical columns. As such she is responsible for gathering customer requirements, application areas and addressing these with new and existing products of the analytical columns line.

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