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

Area of Science:

• Biopharmaceutical development
• Formulation science
• Analytical chemistry

Background:

• Subvisible particles (SVPs) in parenteral biologics pose formulation development challenges.
• Differentiating proteinaceous from non-proteinaceous SVPs is crucial for stability assessment.

Purpose of the Study:

• To develop a robust method for characterizing and distinguishing proteinaceous and non-proteinaceous SVPs.
• To overcome limitations of existing methods like light obscuration (LO) for translucent particles.

Main Methods:

• Utilized Microflow Imaging (MFI) coupled with MVAS software (MFI View Analysis Suite).
• Employed two intensity parameters and a morphological filter for particle analysis.
• Processed MFI data using Lumetics LINK software with an in-house developed filter.

Main Results:

• Successfully characterized and distinguished proteinaceous SVPs from non-proteinaceous SVPs and mixed aggregates.
• Demonstrated a robust approach for analyzing SVPs in protein formulations.
• The method showed effectiveness in separating proteinaceous particulates from others.

Conclusions:

• The developed MFI-based method provides a reliable way to differentiate SVP types in protein formulations.
• This advancement aids in monitoring formulation stability and ensuring therapeutic protein quality.
• The approach offers an improvement over traditional methods for SVP analysis.