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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

1
BMS via PPD, DPST, Material Science & Engineering, New Brunswick, New Jersey 08903, United States.
2
One Squibb Drive, New Brunswick, New Jersey 08903, United States.
3
Celgene, 556 Morris Avenue, Summit, NJ 07901, United States.
4
BMS DPST, PST, New Brunswick, New Jersey 08903, United States.
5
BMS Research & Development, GRS&B, Princeton, New Jersey 08543, United States.

Abstract

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.

KEYWORDS:

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

[Indexed for MEDLINE]

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