The Critical Role of Forced Degradation in Method Development, Manufacturability, and CMC Strategy

Unlock the true potential of your biologic via extended stability studies Join our webinar to explore advanced forced degradation techniques and optimize your chemistry, manufacturing, and controls (CMC) strategy with insights from industry expert Brent Kennedy.

Register Free: https://www.biopharminternational.com/bp_w/forced-degradation

Event Overview:

Join us to discover the critical role of forced degradation studies in method development, manufacturability, aggregation, and other essential quality attributes. This session will delve into the analysis of an IgG1 antibody subjected to various forced degradation pathways, utilizing advanced techniques such as SV-AUC, SEC-MALS, and DLS. Gain valuable insights into sedimentation coefficients, molecular weight, polydispersity, and particle size analysis, and understand how these factors help optimize the CMC strategy of your monoclonal antibody therapeutics.

Key Learning Objectives:

• Understand the importance of forced degradation studies in the development and quality assessment of biotherapeutics.
• Learn how advanced techniques help to understand and evaluate stability and critical quality attributes.
• Explore how data from forced degradation studies inform method development and manufacturability decisions.

Who Should Attend:

• Individuals involved in the development, manufacturing, and quality control of biopharmaceutical products.

Speaker:

Brent Kennedy
Manager
Biologics Analytical Services
Catalent Biologics

Brent Kennedy has over 24 years of experience in biophysical and biochemical analytics. He leads a team of scientists dedicated to the characterization of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs). He also oversees method development and collaborates with clients to address analytical challenges in both GMP and non-GMP contexts. Brent holds a BA in Cell Biology from the University of Northern Colorado and is highly skilled in advanced analytical techniques, including SEC-MALS and SV-AUC technologies.

Register Free: https://www.biopharminternational.com/bp_w/forced-degradation