Separation, Characterization and Discriminant Analysis of Subvisible Particles in Biologics Formulations.

Separation, Characterization and Discriminant Analysis of Subvisible Particles in Biologics Formulations.
Curr Pharm Biotechnol. 2019 Feb 13;:
Authors: Akhunzada ZS, Hubert M, Sahin E, Pratt J
Abstract
The presence of subvisible particles (SVPs) in parenteral formulations of biologics is a major challenge in the development of therapeutic protein formulations. Distinction between proteinaceous and non-proteinaceous SVPs is vital in monitoring formulation stability. The current compendial method based on light obscuration (LO) has limitations in the analysis of translucent/low refractive index particles. A number of attempts have been made to develop an unambiguous method to characterize SVPs, albeit with limited success. Herein, we describe a robust method that characterizes and distinguishes both potentially proteinaceous and non-proteinaceous SVPs in protein formulations using Microflow imaging (MFI) in conjunction with the MVAS software (MFI View Analysis Suite), developed by ProteinSimple. The method utilizes two Intensity parameters and a morphological filter that successfully distinguishes proteinaceous from non-proteinaceous and mixed aggregates. The MFI generated raw data of a protein sample is processed through Lumetics LINK software that applies an in-house developed filter to separate proteinaceous from the rest of the particulates.
PMID: 30767738 [PubMed - as supplied by publisher]

Source: Current Pharmaceutical Biotechnology - February 13, 2019 Category: Biotechnology Authors: Akhunzada ZS, Hubert M, Sahin E, Pratt J Tags: Curr Pharm Biotechnol Source Type: research