Moving From iCE3 to Maurice™ : Maurice Qualification & Implementing icIEF Test Method for mAb Charge Heterogeneity
by María Zabala García, Jennifer Newman, Valentin Sottas and Helen Viehr. Lonza
Scientific Meeting PostersThis poster by Lonza, Visp describes the qualification of an imaged capillary isoelectric focusing (icIEF) method on the Maurice™ system upon transfer from the iCE3 instrument. The goal was to evaluate the performance of the Maurice system for charge variant analysis of process development samples, specifically to evaluate their purity and stability. The qualification included assessment of 11 different parameters including linearity, precision, specificity, equivalency, and robustness, leading to the conclusion that the Maurice system is fit for purpose.