Mastering SEC Biotherapeutic Characterization & Method Development

Overview

During this presentation Shilin will review:

• The importance of SEC in biotherapeutic characterization, its mechanism of action, and theoretical principles.
• Applications of SEC for proteins, antibodies, and other biologics, including method considerations for different sample types.
• Key factors in selecting the correct LC column, buffer, pH, ionic strength, and flow rate to optimize separation and maintain sample integrity.
• Characteristics of an effective and reproducible SEC method, ensuring accurate and consistent results.
• Example workflows and recommended detector settings for specific biologics, including mAbs, AAV, mRNA, and sgRNA.

Key Learning Points

• Gain a deeper understanding of SEC theory, mechanism of action, and its role in biotherapeutic analysis.
• Learn how to select optimal LC columns, buffers, and method conditions for different sample types.
• Explore key considerations such as formulation stability, vial type, pH, and ionic strength for robust method development.
• Identify the desirable attributes of a reproducible SEC method for improved analytical performance.
• Review real-world SEC applications with detector settings optimized for mAbs, AAV, mRNA, and sgRNA characterization.

Who Should Watch

• Researchers and Scientists
  Ideal for those involved in the development and characterization of biotherapeutics.
• Quality Control and In-Process Testing Professionals
  Recommended for professionals focused on ensuring the quality and stability of biotherapeutic products.
• Biopharmaceutical Industry Professionals
  Valuable for those optimizing their SEC methods for biotherapeutic characterization.

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