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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

The Necessity of Extractables and Leachables Qualifications for Lyophilized Drug Products: Some Fallacies Addressed.

Published Date: August 17, 2022

When selecting and qualifying the primary packaging for lyophilized drug products (LDPs), one of the obvious questions is How far should you go into the E&L-qualification process? As the drug product is in a solid state, you would expect that the interaction between the LDP and the components of its container would be low. But is this really the case?

The presentation will provide a view on the current status of regulatory requirements and will address some of the fallacies that exist in E&L qualifications for lyophilized drug products.

Learn more about the presenters below.

Sona Kovackova PhD

Study Director - Nelson Labs

Dr. Kovackova holds a PhD degree in Organic Chemistry from the University of Chemistry and Technology, Prague, Czech Republic. She started her career as a Scientist at the Rega Institute for Medical Research KU Leuven, Belgium and later worked in Quality Control of medicines at the Belgian Institute of Public Health. In 2017, Dr. Kovackova took the position of Study Director at Nelson Labs Europe. Sona currently specializes in Extractables & Leachables studies with a main focus on injectable applications.

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