Enabling Efficient Design of Biological Formulations Through Advanced Characterization

Jayesh Sonje, Seema Thakral, Susan Krueger, Raj Suryanarayanan

Research output: Contribution to journalReview articlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1459-1477
Number of pages19
JournalPharmaceutical research
Volume40
Issue number6
DOIs
StatePublished - Jun 2023

Bibliographical note

Publisher Copyright:
© 2023, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Keywords

  • characterization
  • differential scanning calorimetry (DSC)
  • formulation
  • protein
  • small-angle X-ray scattering
  • small-angle neutron scattering
  • x-ray diffractometry

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