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

Srivalli N Telikepalli1, Michael J Carrier2, Dean C Ripple2

  • 1NIST, Biomolecular Measurement Division, Maryland, Gaithersburg, USA. srivalli.telikepalli@nist.gov.

AAPS Pharmscitech
|December 16, 2022
PubMed
Summary
This summary is machine-generated.

Developing visible protein-like particle standards aims to enhance biotechnology visual inspection and appearance testing. An interlaboratory study found mixed but valuable feedback on particle types for standardization.

Keywords:
reference standardsvisible particlesvisible protein particlesvisual inspection

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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.