Maximize your mRNA and LNP Efficacy: Establishing Critical Quality Attribute Testing from IND to BLA

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:

• mRNA 5’ capping efficiency and characterization of reaction intermediates and impurities to ensure functionalization of the mRNA and protection against the cellular immune response
• 3’ Poly A Tail characterization of tail length heterogeneity and distribution
• Cell-based potency assays to measure the physiological response elicited by the mRNA product and ensure the intended therapeutic effect is produced
• % Encapsulation to enable cellular entry of the mRNA
• LNP lipid composition analysis of common and unique or proprietary lipids as well as low quantity lipids
• DLS analysis as a quick method for ensuring LNP integrity
• FACE analysis for mRNA intactness and purity 

Watch On-Demand