Enabling Efficient Design of Biological Formulations Through Advanced Characterization

Jayesh Sonje; Seema Thakral; Susan Krueger; Raj Suryanarayanan

doi:10.1007/s11095-023-03495-z

Enabling Efficient Design of Biological Formulations Through Advanced Characterization

Jayesh Sonje, Seema Thakral, Susan Krueger, Raj Suryanarayanan

Pharmaceutics

Research output: Contribution to journal › Review article › peer-review

3 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 language	English (US)
Pages (from-to)	1459-1477
Number of pages	19
Journal	Pharmaceutical research
Volume	40
Issue number	6
DOIs	https://doi.org/10.1007/s11095-023-03495-z
State	Published - Jun 2023

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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

PubMed: MeSH publication types

Journal Article
Review

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10.1007/s11095-023-03495-z

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title = "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.",

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author = "Jayesh Sonje and Seema Thakral and Susan Krueger and Raj Suryanarayanan",

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AU - Thakral, Seema

AU - Krueger, Susan

AU - Suryanarayanan, Raj

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AB - 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.

KW - characterization

KW - differential scanning calorimetry (DSC)

KW - formulation

KW - protein

KW - small-angle X-ray scattering

KW - small-angle neutron scattering

KW - x-ray diffractometry

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Enabling Efficient Design of Biological Formulations Through Advanced Characterization

Abstract

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