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Learn advanced analytical methods for characterizing mRNA therapeutics through liquid chromatography techniques in this 42-minute webinar presented by Dr. Nagarjun Kasaraneni from Labroots. Explore the critical quality attributes (CQAs) of mRNA drug substances and drug products, focusing on how ion-pair reverse-phase (IP-RP) HPLC, ion-exchange chromatography (IEX), and size-exclusion chromatography (SEC) enable sensitive, high-resolution separation and quantification of mRNA-related impurities including truncated transcripts, double-stranded RNA (dsRNA), and residual DNA or enzymes. Discover a comprehensive LC-based analytical framework for evaluating mRNA identity, integrity, purity, and stability through detailed case studies demonstrating method development and performance in early-phase development. Examine the integration of LC methods with orthogonal techniques such as UV, fluorescence, and mass spectrometry to provide complete mRNA quality assessment. Understand how these analytical approaches support regulatory expectations and ensure product consistency throughout the mRNA therapeutic product lifecycle, drawing from Dr. Kasaraneni's extensive experience in analytical development, gene therapy, and protein characterization at leading biotech companies including Sana Biotechnology and Editas Medicine. Gain insights into overcoming analytical development challenges in biopharmaceutical innovation while learning about cGMP guidelines, process validation, and assay qualification for IND-enabling studies and commercialization efforts in cutting-edge mRNA therapeutics.
