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Multiscale Diffusion, Dynamic Cluster Formation, and Intermolecular Interactions in Pharmaceutically Relevant

Ilaria Mosca1,2, Christian Beck1,2, Laura Mateo-Miñarro1,2,3

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Molecular Pharmaceutics
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Summary
This summary is machine-generated.

Highly concentrated monoclonal antibody (mAb) formulations for subcutaneous injection face viscosity challenges. Neutron scattering reveals that short-lived mAb clusters significantly increase viscosity, impacting drug formulation and delivery.

Keywords:
collective diffusionintermolecular interactionsmonoclonal antibodiesneutron spin-echo spectroscopyself-associationsmall-angle neutron scatteringtransient clustersviscosity

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Area of Science:

  • Biopharmaceutical formulation
  • Protein aggregation dynamics
  • Neutron scattering applications

Background:

  • Monoclonal antibodies (mAbs) are key biopharmaceuticals, often given intravenously.
  • Subcutaneous (SC) injection of mAbs offers patient convenience but requires highly concentrated formulations.
  • High mAb concentrations can increase solution viscosity, challenging SC injectability and stability.

Purpose of the Study:

  • Investigate the factors affecting viscosity in concentrated mAb solutions for SC injection.
  • Determine the relationship between mAb concentration, temperature, and solution properties.
  • Understand the protein dynamics and interactions influencing mAb formulation viscosity.

Main Methods:

  • Employed complementary neutron scattering techniques: neutron spin-echo (NSE) and small-angle neutron scattering (SANS).
  • Studied nine different IgG1/IgG4 subtype mAbs in aqueous solutions.
  • Analyzed protein concentration and temperature effects on mAb diffusion, interactions, and dynamics.

Main Results:

  • Confirmed that the formation of short-lived mAb clusters (more than two monomers) is a primary driver of high solution viscosity.
  • Demonstrated the link between mAb clustering, phase separation, and solution opalescence.
  • Bridged the time-scale gap between neutron backscattering (NBS) and viscometry for mAb solutions.

Conclusions:

  • Short-lived mAb clustering is critical for understanding and controlling viscosity in subcutaneous injection formulations.
  • Neutron scattering techniques (NSE and SANS) provide essential insights into mAb solution behavior.
  • Findings aid in developing stable, injectable mAb formulations for improved patient self-administration.