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Low-volume solubility assessment during high-concentration protein formulation development.

Melanie Hofmann1,2, Matthias Winzer2, Christian Weber2

  • 1Friedrich-Alexander University (FAU) Erlangen-Nuremberg, Erlangen, Germany.

The Journal of Pharmacy and Pharmacology
|August 23, 2016
PubMed
Summary

A new static light scattering method predicts high-concentration protein formulation (HCF) solubility by analyzing protein-protein interactions. This material-saving approach accurately determines protein solubility, aiding formulation development.

Keywords:
high-concentration protein formulationsprotein formulation developmentprotein-protein interactionssolubility

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Area of Science:

  • Biochemistry
  • Pharmaceutical Sciences
  • Chemical Engineering

Background:

  • Protein solubility is a critical factor in developing high-concentration protein formulations (HCF).
  • Traditional methods for determining protein solubility are material-intensive and challenging.
  • There is a need for low-volume, predictive approaches for HCF development.

Purpose of the Study:

  • To introduce a material-saving, predictive method for assessing protein solubility in HCF.
  • To correlate protein-protein interactions with maximum protein solubility.
  • To investigate the influence of formulation composition on protein solubility.

Main Methods:

  • Utilized static light scattering to analyze non-ideal solution behavior and protein-protein interactions.
  • Investigated interactions of four therapeutic model proteins across various formulation compositions.
  • Compared deduced solubility from interactions with apparent solubility measured by turbidity and content.

Main Results:

  • Protein-protein interactions accurately predicted protein solubility across all tested formulations.
  • Protein solubility was minimized near the isoelectric point and influenced by buffer salts and ionic strength.
  • Sucrose and arginine/glycine mixtures enhanced solubility, while polysorbate 20 had no effect.

Conclusions:

  • The static light scattering screening procedure is a valuable tool for early-stage protein formulation development.
  • This method enables reliable prediction of protein solubility based on protein interaction analysis.
  • Provided novel data on excipient effects on therapeutic protein apparent solubility.