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Protein Aggregation, sometimes referred to as non-native aggregation, is one of the most challenging issues during biopharmaceutical product manufacturing, storage, shipping and administration. There has been increasing evidence of increased immunogenicity due to protein aggregation, hence it is essential to characterize and quantify aggregates in order to develop safe and stable biopharmaceutical products.

In this talk, Dr. Jain discusses about the types, causes and mechanism of protein aggregation, and the need to characterize aggregates effectively. The various analytical techniques which can be utilized to characterize protein aggregates, and the basis of method selection, have also been highlighted, with an emphasis on Size-Exclusion Chromatography, Dynamic Light Scattering and Analytical Ultracentrifugation.

Learning Objectives:

• Understand the causes of protein aggregation and how you can characterize them
• Understand the regutory requirements to aggregate analysis in biopharmaceutical products
• Understand the pros and cons of different analysis method and find the method for your application

In Collaboration with: 

Ratnesh Jain (Ph.D.)
Biologics Characterization Lab
Institute of Chemical Technology, Matunga, Mumbai