Assessing the Stability of the marketed mAb drug Dupixent® using wNMR

Quality control holds immense importance in pharmaceutical production to ensure therapeutic efficacy and the mitigation of adverse reactions. Formulations of high concentrations of therapeutic proteins are becoming more common, which poses several concerns including complications in formulation and drug administration. Many existing analytical methods aimed at detecting these complications involve opening vials, transferring products, or diluting, which are invasive and can potentially compromise the sample.  Consequently, there is a pressing demand for noninvasive analytical techniques.

Dr. Bruce Yu, IBBR Fellow and MPower Professor, University of Maryland School of Pharmacy along with Dr. Marc Taraban and collaborators at Merck recently published “In-situ biophysical characterization of high-concentration protein formulations using wNMR” in mAbs. They demonstrate the promising application of their water proton nuclear magnetic resonance (wNMR) technology in analyzing high-concentration drug products. The team tested the marketed mAb drug Dupixent^® presented in prefilled syringes with both wNMR (conducted by IBBR researchers) and traditional invasive techniques (conducted by Merck researchers) and revealed a strong correlation between the data sets, confirming wNMR’s sensitivity toward detecting product damages inflicted by physical stresses such as freeze/thaw and heating. wNMR can non-invasively analyze drug products even under heating stress conditions, be performed in situ, and offers simplicity and affordability, which are all additional benefits of this technology.

GEN News has recently highlighted their work and what sets this apart from other stability studies.