Development of Scalable, Thermostable, Spray Dried Vaccine Formulations Applicable for Coronavirus Vaccines

This project will develop spray dried Coronavirus vaccine formulations that do not require extreme cold storage conditions from the point of production to patient application.
Categories
Active Immunization Countermeasures

Industry Need

Most licensed vaccines, including the current COVID-19 vaccines, are liquid formulations that need to be stored and transported in a refrigerated or frozen state, a severe problem for widespread distribution.

Solution

This project sought to address some of the limitations in vaccination logistics, namely the relatively short shelf life of many vaccines and the need for a cold chain.

Outputs/Deliverables

  • Generate RBD of SARS-CoV-2 vaccine antigen and a VLP vaccine antigen.
  • Generate test quantities of spray dried RBD and VLP vaccine antigens for biophysical and biochemical characterization.
  • Conduct solid state analysis of the RBD and VLP vaccine antigens post-spray drying to assess their biophysical properties.
  • Conduct solution state analysis of the RBD and VLP vaccine antigens post-spray drying to assess their biochemical attributes and bioactivity.
  • Screen 24 formulations for each vaccine candidate (12 with and 12 without adjuvant) with a range of excipients and spray drying temperatures. Stability study performed at 4⁰C, 37⁰C and 60⁰C for 14 days.
  • For each lead vaccine candidate (one RBD and one VLP) screen a further 6 iterative formulations (3 with and 3 without adjuvant) by varying percent solids. Stability study performed at 4⁰C, 37⁰C and 60⁰C for 14 days.
  • Generate three batches (reproducibility) of lead spray dried vaccine candidate for RBD antigen and VLP. Stability study performed at -80⁰C, -20⁰C, 4⁰C, 25⁰C, 37⁰C and 60⁰C for 14-days to achieve VVM14 stability.

Impacts

This project will facilitate the development of stable vaccine candidates that do not require a cold chain, allowing them to be quickly, inexpensively, and easily distributed in future coronavirus outbreak, rapidly getting the vaccine to those in need.

Publications

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Project Lead

Fraunhofer USA

Fraunhofer USA