Daniel M Dayeh, Jaclyn Cika, Youmi Moon, Steven Henderson, Deanna Di Grandi, Yue Fu, Kathir Muthusamy, Nisha Palackal, Peter M Ihnat, Erica A Pyles
Heightened interest in messenger RNA (mRNA) therapeutics has accelerated the need for analytical methodologies that facilitate the production of supplies for clinical trials. Forced degradation studies are routinely conducted to provide an understanding of potential weak spots in the molecule that are exploited by stresses encountered during bulk purification, production, shipment, and storage. Consequently, temperature fluctuations and excursions are often experienced during these unit operations and may accelerate mRNA degradation...
April 6, 2024: Journal of Chromatography. A