An Interlaboratory Study to Identify Potential Visible Protein-Like Particle Standards

Area of Science:

• Biotechnology
• Materials Science
• Analytical Chemistry

Background:

• Visual inspection and appearance testing are critical in the biotechnology industry for biotherapeutics.
• Standardized methods and training are needed to improve consistency across different organizations.
• Visible protein-like particles are potential candidates for developing new reference materials.

Purpose of the Study:

• To evaluate if newly developed particle standards mimic proteinaceous particles in biotherapeutics.
• To assess the suitability of these standards for visual inspection and appearance testing.
• To gather industry feedback for the development of reference materials.

Main Methods:

• An interlaboratory study was conducted with 20 labs from 14 participating organizations (industry and government).
• Participants included analysts from formulation, analytical, quality control, and manufacturing labs.
• Two types of particles were circulated: abraded ethylene tetrafluoroethylene (ETFE) and photolithographic particles.

Main Results:

• Qualitative ratings for particle usability varied substantially among and within participating labs.
• Polydisperse ETFE particles (>150 µm) were rated more favorably by formulation and analytical scientists.
• Largest monodisperse photolithographic particles (~300 µm) were rated equally to ETFE by all scientists.
• Modifications to ETFE solutions (settling rate, optical properties) resulted in lower ratings.
• Both particle types received mixed ratings for usability in visual inspection and training.

Conclusions:

• Visible protein-like particle standards show potential for improving standardization in biopharmaceutical quality control.
• Further development and refinement are needed based on mixed industry feedback.
• The study provides valuable insights for the National Institute of Standards and Technology (NIST) in creating effective reference materials.