Zahir Akhunzada
PPD Contractor at BMS ABD New Brunswick
Title: Separation of Protein from Non-Proteinaceous Particles in Biopharmaceutical Formulations with MVAS by Microflow Imaging MFI
Biography
Biography: Zahir Akhunzada
Abstract
The presence of sub-visible particles (SVPs) is a major challenge in the development of therapeutic protein formulations. Distinction between proteinaceous and non-proteinaceous SVPs is vital in monitoring the formulation stability. The current compendial method based on light obscuration (LO) has limitations in analyzing translucent particles, requires large analysis volume and therefore demands urgent need for an unambiguous method to characterize SVPs. A number of attempts have been made to characterize SVPs, albeit with limited success. This presentation reveals a method that successfully characterizes and distinguishes, both potentially proteinaceous and non-proteinaceous SVPs in protein formulations by using Microflow Imaging (MFI) in conjunction with the MVAS (MFI View Analysis Suite) software.