Unlock the full potential of your mRNA and lipid nanoparticle (LNP) products with Critical Quality Attribute (CQA) testing. Advances in mRNA synthesis and lipid nanoparticle (LNP) technologies have made mRNA therapeutics a reality with global public health impacts and tremendous market expansion is expected. Distinct from traditional biologics and small molecule drugs, mRNA products are considered their own unique modality with their own unique analytical challenges. While the USP has draft guidelines, uncertainty remains with the FDA and EMA yet to issue official documentation.  

In this webinar, you will hear from experts who have worked in this space for the last 10 years and have been involved in analyzing almost one hundred mRNA/LNPs compounds.  The team will address development/optimization of select QC methods and critical system suitability parameters for:

Presenters:

	Randy Nielsen, Ph.D. Sr. Project Director Eurofins BioPharma Product Testing
Randy Nielsen, Ph.D., is the Sr. Project Director at Eurofins BioPharma Product Testing who has managed RNA API and LNP drug product stability programs for over 8 years. He has worked in both immunodiagnostic and contract pharmaceutical industries for 30 years. He earned his doctoral degree in chemistry from the University of Arizona, followed by an industrial post-doctoral position at Eli Lilly and Company.
	SuzAnn Hertzler, Ph.D. Project Director Eurofins BioPharma Product Testing
SuzAnn Hertzler, Ph.D., has been a Project Director at Eurofins BioPharma Product Testing for over 14 years. Her specialization is mass spectrometry characterization. She has spent the last decade focused on mRNA characterization, stability testing, and comparability assessments. She earned her doctorate degree in chemistry from Boston University with focus on metalloproteins.

Moderator:

Cody Kalinowski Director, Business Development – Western US Eurofins BioPharma Product Testing

Cody Kalinowski is Eurofins BPT’s Director of Business Development for the Western United States and has been with the company for seven years. As a Regional Sales Manager, Key Account Manager, and Director of Business Development, he has supported Eurofins’ partners developing mRNA therapeutics from preclinical research through to commercialization. Cody has a Bachelor’s degree in Biochemistry and Molecular Biology.