Optimizing Development and Release Efficiency of Protein, AAV, and LNP Therapies Using Multi-Attribute Quantification (MAQ) Light Scattering

In this webinar, a platform method will be presented for characterization that quantifies multiple CQAs for proteins, Adeno-associated viruses (AAV), and lipid nanoparticles (LNPs) by combining multi-angle light scattering (MALS) with size-exclusion chromatography (SEC). This technique and the quantitative data that it provides are positioned to replace or supplement multiple orthogonal assays all along a biotherapeutic workflow and support a more efficient process.

Register Free: https://www.chromatographyonline.com/lcgc_w/MAQ

Event Overview:

Light scattering (LS) techniques, both dynamic LS (DLS) and multi-angle static LS (MALS), have been used as important biophysical characterization and quantification tools for biopharmaceuticals for the past decades. For proteins, DLS, especially in the plate reader format, is used to screen for aggregation presence and propensity and formulation conditions, whereas MALS combined with size exclusion chromatography (SEC) is employed throughout the development cycle of the protein therapeutics.

Key Learning Objectives:

• Learn different LS techniques and what they can measure.
• Familiarize with typical protein applications.
• Learn how to use DLS to screen the size, polydispersity, particle concentration, stability, and formulation of AAV- or LNP- based gene therapy products.
• Learn how to use SEC-MALS or FFF-MALS for multi-attribute quantitation (MAQ).
• Understand the quality attributes quantified by different LS and related techniques.

Who Should Attend:

• Scientists and managers working in the gene and cell therapy field who are seeking a robust and reliable platform method to characterize and quantify AAV and LNP samples
• CMC regulatory specialists looking for a validatable tool that is comparable and complementary to the current assays to monitor and control the key quality attributes of AAV-based and LNP-formulated gene therapy products
• Academic core labs for gene therapies that need a better method to characterize various gene delivery vehicles
  

Speaker:

Michelle Chen
VP of Analytical Sciences
Wyatt Technologies

Dr Michelle Chen is the VP of Analytical Sciences at Wyatt Technology Corporation, located in Santa Barbara, California. Michelle obtained her PhD from the chemical engineering department at Yale University, where she focused on developing novel HPLC approaches for high-speed and high-efficiency separations of biopolymers. Since joining Wyatt, Dr Chen has incorporated multi-angle light scattering and dynamic light scattering detection with HPLC and field-flow fractionation for characterizing synthetic and biological polymers, proteins, and nanoparticles. In recent years, she has led the application team at Wyatt Technology to develop novel methods to characterize and quantify emerging bio-nanoparticles including viral vectors, lipid nanoparticles, and extracellular vesicles.

Register Free: https://www.chromatographyonline.com/lcgc_w/MAQ