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Thin-Film Freeze-Drying Is a Viable Method to Convert Vaccines Containing Aluminum Salts from Liquid to Dry Powder

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Vaccine Delivery Technology

Part of the book series: Methods in Molecular Biology ((MIMB,volume 2183))

Abstract

Aluminum salts are used as an adjuvant in many human and veterinary vaccines. However, aluminum salt-adjuvanted vaccines are sensitive to temperature change and must be stored at 2–8 °C. Inadvertently exposing them to slow freezing temperatures can cause irreversible aggregation of aluminum salt microparticles and loss of potency and/or immunogenicity of the vaccines. There have been efforts to overcome this limitation by either adding stabilizing agents to the liquid vaccine or converting the vaccine from a liquid to a dry powder. Thin-film freeze-drying (TFFD) has proven to be an effective process to convert aluminum salt-adjuvanted vaccines from liquid to dry powder without causing particle aggregation or loss of immunogenicity upon reconstitution. This chapter provides a review of the TFFD process and examples for preparing stable aluminum salt-adjuvanted vaccine dry powders using TFFD.

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Acknowledgments

The authors acknowledge that research supporting this work was funded by a sponsored research agreement from TFF Pharmaceuticals, Inc. (Austin, TX). R.F.A. was supported, in part, by a scholarship from the King Saud University. C.M. was supported, in part, by TFF Pharmaceuticals.

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Authors and Affiliations

  1. Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX, USA

    Riyad F. Alzhrani, Haiyue Xu, Chaeho Moon, Robert O. Williams III & Zhengrong Cui

  2. Department of Biomedical Engineering, Cockrell School of Engineering, The University of Texas at Austin, Austin, TX, USA

    Laura J. Suggs

Authors
  1. Riyad F. Alzhrani
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  2. Haiyue Xu
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  3. Chaeho Moon
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  4. Laura J. Suggs
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  5. Robert O. Williams III
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  6. Zhengrong Cui
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Corresponding author

Correspondence to Zhengrong Cui .

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Editors and Affiliations

  1. Department of Chemical and Biological Engineering, University at Buffalo, The State University of New York, Buffalo, NY, USA

    Blaine A. Pfeifer

  2. Department of Chemical and Biological Engineering, University at Buffalo, The State University of New York, Buffalo, NY, USA

    Andrew Hill

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Alzhrani, R.F., Xu, H., Moon, C., Suggs, L.J., Williams, R.O., Cui, Z. (2021). Thin-Film Freeze-Drying Is a Viable Method to Convert Vaccines Containing Aluminum Salts from Liquid to Dry Powder. In: Pfeifer, B.A., Hill, A. (eds) Vaccine Delivery Technology. Methods in Molecular Biology, vol 2183. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-0795-4_27

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  • DOI: https://doi.org/10.1007/978-1-0716-0795-4_27

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  • Publisher Name: Humana, New York, NY

  • Print ISBN: 978-1-0716-0794-7

  • Online ISBN: 978-1-0716-0795-4

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