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A Thermostable, Flexible RNA Vaccine Delivery Platform for Pandemic Response

View ORCID ProfileAlana Gerhardt, Emily Voigt, Michelle Archer, Sierra Reed, Elise Larson, Neal Van Hoeven, Ryan Kramer, Christopher Fox, Corey Casper
doi: https://doi.org/10.1101/2021.02.01.429283
Alana Gerhardt
1Product Development Group, Infectious Disease Research Institute, Seattle, WA, USA.
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  • ORCID record for Alana Gerhardt
  • For correspondence: alana.gerhardt@idri.org emily.voigt@idri.org
Emily Voigt
2RNA Vaccines Group, Infectious Disease Research Institute, Seattle, WA, USA.
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  • For correspondence: alana.gerhardt@idri.org emily.voigt@idri.org
Michelle Archer
1Product Development Group, Infectious Disease Research Institute, Seattle, WA, USA.
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Sierra Reed
1Product Development Group, Infectious Disease Research Institute, Seattle, WA, USA.
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Elise Larson
3Formulation Sciences Group, Infectious Disease Research Institute, Seattle, WA, USA.
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Neal Van Hoeven
2RNA Vaccines Group, Infectious Disease Research Institute, Seattle, WA, USA.
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Ryan Kramer
1Product Development Group, Infectious Disease Research Institute, Seattle, WA, USA.
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Christopher Fox
3Formulation Sciences Group, Infectious Disease Research Institute, Seattle, WA, USA.
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Corey Casper
1Product Development Group, Infectious Disease Research Institute, Seattle, WA, USA.
2RNA Vaccines Group, Infectious Disease Research Institute, Seattle, WA, USA.
3Formulation Sciences Group, Infectious Disease Research Institute, Seattle, WA, USA.
4Departments of Medicine and Global Health, University of Washington, Seattle, WA, USA.
5Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
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Abstract

Current RNA vaccines against SARS-CoV-2 are limited by instability of both the RNA and the lipid nanoparticle delivery system, requiring storage at −20°C or −70°C and compromising universally accessible vaccine distribution. This study demonstrates the thermostability and adaptability of a nanostructured lipid carrier (NLC) RNA vaccine delivery system for use in pandemic preparedness and pandemic response. Liquid NLC is stable at refrigerated temperatures for ≥ 1 year, enabling stockpiling and rapid deployment by point-of-care mixing with any vaccine RNA. Alternatively, NLC complexed with RNA may be readily lyophilized and stored at room temperature for ≥ 8 months or refrigerated temperature for ≥ 21 months. This thermostable RNA vaccine platform could significantly improve distribution of current and future pandemic response vaccines, particularly in low-resource settings.

One Sentence Summary An RNA vaccine delivery system stable at room temperature for 8+ months and refrigerated for 21+ months.

Competing Interest Statement

C.F. and N.V.H. are co-inventors on patent applications relating to PCT/US2018/37783, Nanostructured Lipid Carriers and stable emulsions and uses thereof. M.A., A.G., and R.K. are co-inventors on U.S. patent application nos. 63/075,032 and 63/107,383, Co-lyophilized RNA and Nanostructured Lipid Carrier. All other authors declare they have no competing interests.

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
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Posted February 02, 2021.
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A Thermostable, Flexible RNA Vaccine Delivery Platform for Pandemic Response
Alana Gerhardt, Emily Voigt, Michelle Archer, Sierra Reed, Elise Larson, Neal Van Hoeven, Ryan Kramer, Christopher Fox, Corey Casper
bioRxiv 2021.02.01.429283; doi: https://doi.org/10.1101/2021.02.01.429283
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A Thermostable, Flexible RNA Vaccine Delivery Platform for Pandemic Response
Alana Gerhardt, Emily Voigt, Michelle Archer, Sierra Reed, Elise Larson, Neal Van Hoeven, Ryan Kramer, Christopher Fox, Corey Casper
bioRxiv 2021.02.01.429283; doi: https://doi.org/10.1101/2021.02.01.429283

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