Send to

Choose Destination
Curr Pharm Biotechnol. 2019;20(3):232-244. doi: 10.2174/1389201020666190214100840.

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

Author information

BMS via PPD, DPST, Material Science & Engineering, New Brunswick, New Jersey 08903, United States.
One Squibb Drive, New Brunswick, New Jersey 08903, United States.
Celgene, 556 Morris Avenue, Summit, NJ 07901, United States.
BMS DPST, PST, New Brunswick, New Jersey 08903, United States.
BMS Research & Development, GRS&B, Princeton, New Jersey 08543, United States.



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 SVPs from non-proteinaceous SVPs 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.


MFI; MVAS; Protein aggregation; discriminant analysis; lumetics link; non-proteinaceous particles; proteinaceous particles; subvisible particles.

[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Bentham Science Publishers Ltd.
Loading ...
Support Center