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Structural Studies of Macromolecules in Solution using Small Angle X-Ray Scattering
Published on: November 5, 2018
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Small-scale screening method for low-viscosity antibody solutions using small-angle X-ray scattering.
Masakazu Fukuda1, Atsushi Watanabe1, Akira Hayasaka2
1Production Engineering Department, Chugai Pharmaceutical Co., Ltd., 5-5-1 Ukima, Kita-ku, Tokyo 115-8543, Japan.
Summary
This study identifies self-association in monoclonal antibody (mAb) solutions using small-angle X-ray scattering (SAXS). This method enables early screening of low-viscosity antibody formulations for improved drug development.
Area of Science:
- Biochemistry
- Materials Science
- Pharmaceutical Science
Background:
- Monoclonal antibodies (mAbs) are crucial therapeutics, but high concentrations can lead to self-association, increasing viscosity.
- Understanding self-association is key for developing stable, injectable antibody formulations.
Purpose of the Study:
- To determine the concentration range for self-association in humanized IgG mAb solutions.
- To develop a practical method for screening low-viscosity antibody solutions using small-angle X-ray scattering (SAXS).
Main Methods:
- Investigated self-association in mAb solutions across various concentrations.
- Utilized small-angle X-ray scattering (SAXS) for particle size analysis.
- Correlated SAXS data with viscosity measurements at high concentrations.
Main Results:
- Lower-viscosity mAb3 showed no self-association from 1-80 mg/mL.
- Higher-viscosity mAb1 exhibited self-association at 10-20 mg/mL, exacerbated by lower temperatures.
- SAXS particle size parameters at 15 mg/mL correlated well with high-concentration viscosities.
Conclusions:
- SAXS analysis requires minimal sample (0.15 mg), facilitating early-stage development.
- The proposed SAXS method is valuable for developing concentrated mAb therapeutics with enhanced manufacturability and usability for subcutaneous injection.
