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Stabilization of Proteins in Dry Powder Formulations Using Supercritical Fluid Technology
Abstract
Therapeutic proteins have become essential in the treatment of many diseases. Their formulation in dry form is often required to improve their stability. Traditional freeze-drying or spray-drying processes are often harmful to labile proteins and could be replaced by supercritical fluid (SCF) drying to produce particles with defined physicochemical characteristics in a mild single step. A survey of the current SCF drying processes for proteins is presented to give insight into the effect of SCF drying on protein stability and to identify issues that need further investigation. Methods used for drying aqueous and organic protein solutions are described. In particular, effects of process and formulation parameters on particle formation and protein stability are discussed. Although SCF methodology for drying proteins is still in its infancy, it can provide a serious alternative to existing drying methods for stabilizing proteins.
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Supercritical drying techniques have been shown to be feasible for other macromolecular biotech products, such as proteins.
“they have been shown to be feasible –with their pros and cons– for other macromolecular biotech products, such as proteins (Jovanović et al., 2004).”
From mRNA-lipid nanoparticle COVID-19 vaccines: structure and stability (2021) · cites this paper as Jovanović et al., 2004
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mRNA-lipid nanoparticle COVID-19 vaccines: structure and stability
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Metadata
- Authors
- Jovanović, N., Bouchard, A., Hofland, G. W., Witkamp, G.-J., Crommelin, D. J. A., & Jiskoot, W.
- Affiliations
- Utrecht University (NL)
- Delft University of Technology (NL)
- Corresponding author
- Jiskoot, Wim
- Venue
- Pharmaceutical Research
- Published
- 2004-11
- Volume
- 21
- Issue
- 11
- Pages
- 1955-1969
- ISSN
- 0724-8741 (ISSN-L)
- 1573-904X
- OpenAlex
- W2054260828
- Cited by
- 111
- References
- 54
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 5 · 2023: 4 · 2022: 4 · 2021: 8 · 2020: 3 · 2019: 3 · 2018: 1 · 2017: 3 · 2016: 1 · 2015: 4 · 2014: 3 · 2013: 6 · 2012: 4
- FWCI
- 7.45
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Pharmaceutical Research (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Chemistry › Physical and Theoretical Chemistry › Phase Equilibria and Thermodynamics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
- Life Sciences › Agricultural and Biological Sciences › Food Science › Microencapsulation and Drying Processes
- Keywords
- supercritical drying, protein stabilization, therapeutic proteins, dry powder formulation, freeze-drying alternative, particle formation, protein stability, formulation parameters
- MeSH terms
- Carbon Dioxide, Chemistry, Pharmaceutical, Desiccation, Powders, Proteins, Solutions
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