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Fluorescence detection methods for microfluidic droplet platforms
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Micro-flow imaging multi-instrument evaluation for sub-visible particle detection.

Ibrahim Fawaz1, Simone Schaz1, Armin Boehrer2

  • 1Boehringer Ingelheim Pharma GmbH & Co. KG, Innovation Unit, Pharmaceutical Development Biologicals, 88397 Biberach an der Riss, Germany.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|January 28, 2023
PubMed
Summary

This study evaluated seven Micro-Flow Imaging (MFI™) instruments for sub-visible particle (SVP) analysis in biologics. Results showed instrument comparability and precision varied with particle type, highlighting challenges in consistent data interpretation across multiple devices.

Keywords:
BMI - Backgrounded membrane imagingFlow imagingLO - light obscurationLight obscurationMFI - Micro Flow ImagingParticle sizingSub-visible particles

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Biotechnology

Background:

  • Sub-visible particles (SVPs) are critical quality attributes in pharmaceutical products, necessitating robust monitoring during development.
  • Pharmacopeial methods like light obscuration (LO) have limitations, particularly for smaller translucent SVPs (<10 µm).
  • Micro-Flow Imaging (MFI™) offers improved sensitivity but widespread use across multiple devices presents data consistency challenges.

Purpose of the Study:

  • To systematically evaluate the counting and size precision and accuracy of seven MFI™ instruments.
  • To assess instrument comparability using an inter-comparable approach mimicking daily workflows.
  • To compare MFI™ performance against alternative methods like LO and Backgrounded Membrane Imaging (BMI).

Main Methods:

  • Evaluation of seven MFI™ instruments using NIST certified counting standards, protein-coated particles, and stress-induced monoclonal antibody particles.
  • Inter-instrument comparison employing an approach to mimic routine laboratory operations.
  • Comparative analysis with light obscuration (LO) and Backgrounded Membrane Imaging (BMI) methods.

Main Results:

  • Instrument precision and accuracy, along with inter-instrument comparability, were found to be dependent on particle source and material properties.
  • MFI™ instruments demonstrated high precision (<15%) for NIST standards, with data generally within the same order of magnitude.
  • Limitations were observed in the upper and lower detection limits for MFI™ instruments, contrary to manufacturer claims. Proteinaceous particles showed statistically significant differences in counts, though diameter measurements were consistent.

Conclusions:

  • While MFI™ instruments show high precision for specific particle types, their performance and comparability vary based on sample characteristics.
  • The study identified challenges in achieving consistent SVP quantification across multiple MFI™ devices, impacting data interpretation and reliability.
  • Further standardization and validation are needed to ensure accurate and reproducible SVP analysis using MFI™ technology in pharmaceutical development.