Heat stable and intrinsically sterile liquid protein formulations
Abstract Over 80% of biologic drugs, and 90% of vaccines, require temperature-controlled conditions throughout the supply chain to minimize thermal inactivation and contamination. This cold chain is costly, requires stringent oversight, and is impractical in remote environments. Here, we report chem...
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2024-12-01
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| Series: | Nature Communications |
| Online Access: | https://doi.org/10.1038/s41467-024-55304-9 |
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| author | Atip Lawanprasert Harminder Singh Sopida Pimcharoen Mariangely González Vargas Arshiya Dewan Girish S. Kirimanjeswara Scott H. Medina |
| author_facet | Atip Lawanprasert Harminder Singh Sopida Pimcharoen Mariangely González Vargas Arshiya Dewan Girish S. Kirimanjeswara Scott H. Medina |
| author_sort | Atip Lawanprasert |
| collection | DOAJ |
| description | Abstract Over 80% of biologic drugs, and 90% of vaccines, require temperature-controlled conditions throughout the supply chain to minimize thermal inactivation and contamination. This cold chain is costly, requires stringent oversight, and is impractical in remote environments. Here, we report chemical dispersants that non-covalently solvate proteins within fluorous liquids to alter their thermodynamic equilibrium and reduce conformational flexibility. This generates non-aqueous, fluorine-based liquid protein formulations that biochemically rigidify protein structure to yield thermally stable biologics at extreme temperatures (up to 90 °C). These non-aqueous formulations are impervious to contamination by microorganismal pathogens, degradative enzymes, and environmental impurities, and display comparable pre-clinical pharmacokinetics and safety profiles to standard saline protein samples. As a result, we deliver a fluorochemical formulation paradigm that may limit the need for cold chain logistics of protein reagents and biopharmaceuticals. |
| format | Article |
| id | doaj-art-f363ec71031d49c785184cf3bc309500 |
| institution | Kabale University |
| issn | 2041-1723 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Nature Communications |
| spelling | doaj-art-f363ec71031d49c785184cf3bc3095002025-01-05T12:35:52ZengNature PortfolioNature Communications2041-17232024-12-0115111010.1038/s41467-024-55304-9Heat stable and intrinsically sterile liquid protein formulationsAtip Lawanprasert0Harminder Singh1Sopida Pimcharoen2Mariangely González Vargas3Arshiya Dewan4Girish S. Kirimanjeswara5Scott H. Medina6Department of Biomedical Engineering, Pennsylvania State UniversityDepartment of Biomedical Engineering, Pennsylvania State UniversityDepartment of Biomedical Engineering, Pennsylvania State UniversityDepartment of Biomedical Engineering, Pennsylvania State UniversityDepartment of Veterinary and Biomedical Sciences, Pennsylvania State UniversityDepartment of Veterinary and Biomedical Sciences, Pennsylvania State UniversityDepartment of Biomedical Engineering, Pennsylvania State UniversityAbstract Over 80% of biologic drugs, and 90% of vaccines, require temperature-controlled conditions throughout the supply chain to minimize thermal inactivation and contamination. This cold chain is costly, requires stringent oversight, and is impractical in remote environments. Here, we report chemical dispersants that non-covalently solvate proteins within fluorous liquids to alter their thermodynamic equilibrium and reduce conformational flexibility. This generates non-aqueous, fluorine-based liquid protein formulations that biochemically rigidify protein structure to yield thermally stable biologics at extreme temperatures (up to 90 °C). These non-aqueous formulations are impervious to contamination by microorganismal pathogens, degradative enzymes, and environmental impurities, and display comparable pre-clinical pharmacokinetics and safety profiles to standard saline protein samples. As a result, we deliver a fluorochemical formulation paradigm that may limit the need for cold chain logistics of protein reagents and biopharmaceuticals.https://doi.org/10.1038/s41467-024-55304-9 |
| spellingShingle | Atip Lawanprasert Harminder Singh Sopida Pimcharoen Mariangely González Vargas Arshiya Dewan Girish S. Kirimanjeswara Scott H. Medina Heat stable and intrinsically sterile liquid protein formulations Nature Communications |
| title | Heat stable and intrinsically sterile liquid protein formulations |
| title_full | Heat stable and intrinsically sterile liquid protein formulations |
| title_fullStr | Heat stable and intrinsically sterile liquid protein formulations |
| title_full_unstemmed | Heat stable and intrinsically sterile liquid protein formulations |
| title_short | Heat stable and intrinsically sterile liquid protein formulations |
| title_sort | heat stable and intrinsically sterile liquid protein formulations |
| url | https://doi.org/10.1038/s41467-024-55304-9 |
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