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Nanoparticles for Protein Sensing in Primary Containers: Interaction Analysis and Application.

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Silver nanoparticles (AgNPs) detect therapeutic protein adsorption in drug containers. This method reveals protein structural changes and container compatibility, crucial for drug development and quality control.

Keywords:
Monoclonal antibodyPrefilled syringesPrimary containerSilver nanoparticlesSynthetic copolymer

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Area of Science:

  • Nanotechnology
  • Biomaterials Science
  • Pharmaceutical Science

Background:

  • Silver nanoparticles (AgNPs) interact with proteins, altering their optical properties.
  • This interaction forms a protein corona and can modify protein structure.
  • AgNP-protein interactions offer potential for sensing protein adsorption in drug packaging.

Purpose of the Study:

  • To characterize AgNP-protein interactions and structural changes.
  • To develop a novel AgNP-based sensing method for protein adsorption in primary containers.
  • To assess the compatibility of therapeutic proteins with prefillable glass syringes (PFS).

Main Methods:

  • Transmission electron microscopy (TEM) and UV-Vis spectroscopy to characterize AgNPs and protein-AgNP complexes.
  • Circular dichroism (CD) and fluorescence spectroscopy to study protein structural modifications.
  • Surface plasmon resonance (SPR) shifts of AgNPs to quantify protein adsorption in PFS.

Main Results:

  • Protein corona formation around AgNPs caused SPR band shifts.
  • Monoclonal antibody (mAb) and synthetic copolymer (SC) showed significant structural changes upon AgNP interaction.
  • 74% of mAb and 94% of SC exposed PFS showed detectable protein adsorption.
  • Negligible adsorption (<1 ng) was observed in 15% of tested PFS.

Conclusions:

  • AgNP-based SPR sensing is a viable method for detecting protein adsorption in primary containers.
  • Therapeutic protein adsorption varies significantly between different PFS models.
  • Case-by-case compatibility assessments are essential for therapeutic proteins and their primary packaging.