Enabling Efficient Design of Biological Formulations Through Advanced Characterization
- PMID: 36959413
- DOI: 10.1007/s11095-023-03495-z
Enabling Efficient Design of Biological Formulations Through Advanced Characterization
Abstract
The present review summarizes the use of differential scanning calorimetry (DSC) and scattering techniques in the context of protein formulation design and characterization. The scattering techniques include wide angle X-ray diffractometry (XRD), small-angle neutron scattering (SANS) and small-angle X-ray scattering (SAXS). While DSC is valuable for understanding thermal behavior of the excipients, XRD provides critical information about physical state of solutes during freezing, annealing and in the final lyophile. However, as these techniques lack the sensitivity to detect biomolecule-related transitions, complementary characterization techniques such as small-angle scattering can provide valuable insights.
Keywords: characterization; differential scanning calorimetry (DSC); formulation; protein; small-angle X-ray scattering; small-angle neutron scattering; x-ray diffractometry.
© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
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References
-
- Carpenter JF, Chang BS, Garzon-Rodriguez W, Randolph TW. Rational design of stable lyophilized protein formulations: theory and practice. Rational design of stable protein formulations. 2002 109–133.
-
- W W. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm. 2000;203:1–60.
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