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A Platform for Preparing Homogeneous Proteinaceous Subvisible Particles With Distinct Morphologies.

Malthe Møhl Schack1, Eva Horn Møller2, John F Carpenter3

  • 1Department of Pharmacy, Section of Pharmaceutical Design and Drug Delivery, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk A/S, Måløv, Denmark.

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|March 26, 2018
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Summary

Researchers developed uniform protein particles from human insulin using specific stress conditions. These well-defined particles can help study the impact of drug product particulates on patients.

Keywords:
microparticle(s)microscopyparticle sizephysical stabilityprotein aggregationprotein formulation(s)

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Area of Science:

  • Biopharmaceutical science
  • Protein aggregation
  • Drug product quality

Background:

  • Growing concern over subvisible particles in biologic drugs and their potential to induce antidrug antibodies.
  • Challenges in identifying risky particle properties due to heterogeneity of protein aggregates.
  • Need for well-defined, homogenous protein particle materials for research.

Purpose of the Study:

  • To develop a method for generating homogenous micrometer-sized protein particles from human insulin.
  • To create a diverse set of particles with varying morphologies and protein conformations.
  • To establish a standardized platform for studying insulin subvisible particles.

Main Methods:

  • Utilized simple, pharmaceutically relevant stress conditions on human insulin formulations.
  • Varied insulin self-association patterns through formulation strategies.
  • Generated 8 distinct populations of homogenous micrometer-sized protein particles.

Main Results:

  • Successfully produced highly homogenous micrometer-sized protein particles from human insulin.
  • Demonstrated that particle formation is dependent on formulation and stress conditions, not random.
  • Characterized particles with diverse morphologies and protein conformations.

Conclusions:

  • The developed method yields reproducible and homogenous protein particles.
  • These homogenous particles serve as a valuable standard for investigating the immunogenicity of insulin drug products.
  • Provides a foundation for understanding the relationship between particle characteristics and biological response.