Reference material development for calibration and verification of image-based particle analyzers.

Area of Science:

• Biopharmaceutical Analysis
• Particle Characterization
• Instrument Calibration

Background:

• Accurate measurement of suspended protein particles in biopharmaceuticals is critical.
• Current polystyrene bead standards do not adequately challenge particle analysis instruments.
• Instrument variability in protein particle measurement necessitates improved reference materials.

Purpose of the Study:

• To evaluate a novel reference material for calibrating particle analysis instruments.
• To harmonize the performance of Micro-Flow Imaging (MFI) instruments.
• To improve the accuracy and consistency of protein particle concentration measurements.

Main Methods:

• Evaluation of a promising reference candidate with properties similar to protein aggregates.
• Application of the reference material to harmonize Micro-Flow Imaging (MFI) instrument performance.
• Comparative analysis of particle measurements using the new reference material.

Main Results:

• The evaluated reference candidate demonstrated suitability for particle analysis.
• Use of the reference population significantly increased measurement consistency among instruments.
• Harmonized MFI instruments showed improved agreement in characterizing protein particle suspensions.

Conclusions:

• A suitable reference population is essential for accurate and consistent protein particle sizing and quantification.
• The developed reference material effectively harmonizes Micro-Flow Imaging (MFI) instrument performance.
• This work advances reliable particle analysis in biopharmaceutical development and quality control.