Understanding Molecules: Choosing the Right Method for Characterizing Biologics

The world of biologics is progressing rapidly. Analytical methods that were utilized ten years ago may no longer be relevant. The FDA and EMA now expect manufacturers to develop analytical plans that employ the latest methodologies, but they must be thoroughly characterized.

While it was once easy to ignore biophysical methods because they were considered difficult to implement and understand, that can no longer be the case. Biophysical methods are now mainstream, having become an part of the regulatory agenda and an essential component in helping manufacturers and regulators gain a full understanding of biologics.

Objective

This webinar looks at biophysical methods like NMR, DSC, and MALS, explaining how they function as stand-alone methods, and will cover orthogonal methods to see how they can be leveraged to qualify, validate, and give confidence to the methodology.

Learn to choose and apply the right methods at the right time to fully understand your biologic molecules.

Agenda

• Higher Order Structure Methods: NMR, X-Ray, and What Else?
• Biophysics Characterization – What Should You Know About Your Release Methods?
• How Does Early Characterization Facilitate Faster Drug Product Development?
• Q&A

Presenter

Edward R. Zartler, Ph.D.
Director of Biopharmaceutical, USA

Dr. Zartler received his Ph.D. in Chemistry from the University of Pennsylvania. During a 20 year career, he has worked in vaccine and biologics method development, release, stability and characterization, and on proteins and nucleic acid therapies.

Audience

This webinar is open to everyone in the biopharmaceutical sector – from students to laboratory managers and decision makers.

For more information, please contact:

Aurelia Resines
Global Marketing Manager
t: +41 22 739 9111