Rapid Visible and Subvisible Particle Measurements for Development, Formulations, and Quality Control

Rapid Visible and Subvisible Particle Measurements for Development, Formulations, and Quality Control

Brought to you by Waters | Wyatt Technology

Overview

Subvisible particles in biopharmaceuticals are strongly linked to immunogenicity and are a leading cause of FDA drug recalls. Detecting these particles early in drug development is critical for creating safe, stable, and effective therapies. Using United States Pharmacopeia (USP) compliant methods early aligns development with quality control (QC), simplifying and streamlining method transfer.

This application note introduces a precise, high-throughput, automated particle analysis workflow for complex, high viscosity, or low volume biopharmaceuticals like proteins, antibodies, viral vectors, and lipid nanoparticles (LNPs) using backgrounded membrane imaging (BMI). BMI brings USP-compliant particle analysis upstream while remaining QC-ready, enabling earlier detection, faster decisions, and greater confidence in product quality. This simple process minimizes manual effort and integrates with automation tools. Validated with bead standards and human IgG, BMI helps scientists identify risks before they impact clinical progress.

Key Objectives

How to perform high-throughput USP <788> compliant particle analysis.
Why membrane microscopy is the preferred particle method for low-volume, complex samples.
How to maintain reproducibility and ensure particle count accuracy and compliance.
How BMI enables you to count & identify particles from 10 µL to 10 mL of sample.

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