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Characterization of Protein Aggregation in Therapeutic Peptides and Monoclonal Antibodies

1 hour 50 minutes

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

Dr. Ratnesh Jain is an Assistant Professor in Engineering Sciences and Ramalingaswami Fellow at Department of Chemical Engineering, Institute of Chemical Technolog, Matunga, Mumbai. Dr Jain is heading the Biologics Characterization Lab at ICT. From 2012, Dr Jain has taken various initiateive towards biosimilar characterization and educational initiatives like Biosimilar Workshop, to support biopharmaceutical sector related skill development, infrastructure development and entrepreneurship. He has more than 79 publications and 200 presentations. He is a consultant for various biopharmaceutical industries. He is also advising and assisting various biopharma startups for innovation solutions in the biopharma industry





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