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Gauging colloidal and thermal stability in human IgG1-sugar solutions through diffusivity measurements
Jonathan Rubin1, Aditi Sharma, Lars Linden
1School of Chemical & Biomolecular Engineering, Georgia Institute of Technology , Atlanta, Georgia 30332-0100, United States.
The Journal of Physical Chemistry. B
|February 22, 2014
Summary
This study introduces a rapid method to assess sugar stabilization for monoclonal antibodies. Measuring the protein
Area of Science:
- Biopharmaceutical formulation
- Protein stability analysis
- Protein-sugar interactions
Background:
- Monoclonal antibodies (mAbs) are a rapidly expanding class of biotherapeutics.
- Ensuring the colloidal and conformational stability of mAbs in liquid formulations is critical for therapeutic efficacy and economic viability.
- Traditional methods to determine optimal sugar stabilizers are time-consuming and sample-intensive.
Purpose of the Study:
- To develop a rapid, high-throughput method for evaluating the stabilizing effects of different sugars on monoclonal antibodies.
- To correlate protein-sugar interaction parameters with established stability metrics.
- To facilitate the formulation of stable protein therapeutics.
Main Methods:
- Utilized dynamic light scattering (DLS) to measure the diffusive virial coefficient (kD) of a human IgG1 antibody in the presence of various sugars.
- Correlated kD values with experimental aggregation rate constants at the onset of aggregation.
- Assessed correlation with antibody melting temperatures (Tm) in different sugar solutions.
- Employed circular dichroism spectroscopy to investigate sugar-mediated thermal stabilization mechanisms.
Main Results:
- The diffusive virial coefficient (kD) accurately predicts the extent of stabilization provided by different sugars for the human IgG1 antibody.
- kD measurements showed a strong correlation with experimental aggregation rates and melting temperatures.
- Dynamic light scattering offers a noninvasive, high-throughput approach to assess protein-sugar interactions.
Conclusions:
- The diffusive virial coefficient (kD) serves as a reliable indicator for selecting optimal sugar stabilizers in monoclonal antibody formulations.
- This DLS-based method significantly accelerates the screening process for protein therapeutic formulation.
- Understanding sugar-protein interactions is key to enhancing the stability and efficacy of biotherapeutics.
