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Review
. 2023 Jun;40(6):1459-1477.
doi: 10.1007/s11095-023-03495-z. Epub 2023 Mar 23.

Enabling Efficient Design of Biological Formulations Through Advanced Characterization

Jayesh Sonje  1   2 , Seema Thakral  3 , Susan Krueger  4   5 , Raj Suryanarayanan  6
Affiliations
Review

Enabling Efficient Design of Biological Formulations Through Advanced Characterization

Jayesh Sonje et al. Pharm Res. 2023 Jun.

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.

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