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Updated: Jan 29, 2026
Formulation and Characterization of Bioactive Agent Containing Nanodisks
Published on: March 17, 2023
Separation, Characterization and Discriminant Analysis of Subvisible Particles in Biologics Formulations
Zahir S Akhunzada1,2, Mario Hubert3, Erinc Sahin4
1BMS via PPD, DPST, Material Science & Engineering, New Brunswick, New Jersey 08903, United States.
Background:
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.
Methods:
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.
Results:
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 SVPs from non-proteinaceous SVPs and mixed aggregates.
Conclusion:
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.
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