Thermostabilize Coronavirus Vaccines: Formulation and Process Development and Rapid Scale-up Through Modeling and QbD Experimentation

Physical Sciences Inc (PSI) has been awarded a research program from the National Institute for Innovation Manufacturing Biopharmaceuticals (NIIMBL) to demonstrate the development of a thermostabilized coronavirus surrogate mRNA vaccine. This program is in collaboration with the University of Connecticut (UConn), The University of Massachusetts Lowell (UML), and Merck & Co., Inc.

The program will include the development of a stable surrogate Lipid NanoParticle (LNP) encapsulated mRNA vaccine formulation for freeze-drying and the application of a heat and mass transfer model of heterogeneous primary freeze-drying for manufacturing processes development. This project targets the need for improved thermal stability of vaccines.

Two of the current FDA-authorized COVID-19 vaccines are formulated as LNP-encapsulated mRNA. The LNPs vary between the current vaccines presenting challenges for freeze-drying as each formulation may require different freeze-drying conditions. Testing the stability of LNPs (and mRNA) after lyophilization to ensure efficacy is not lost during freeze-drying is of paramount importance, and it is pertinent to test LNPs and formulations to determine best practices for freeze-drying future coronavirus vaccines.

This effort leverages a primary freeze-drying model developed and tested through NIIMBL support and a pilot-scale freeze-dryer located at the UML LyoBay. This program will mature and validate this model with a focus on considerations specific to vaccines. The model is distinct from many other heat and mass transfer models of lyophilization because it includes calculations to account for process heterogeneity and scale-up.

The overall goal of this program is to develop vaccine lyophilization formulations and processes to thermostabilize coronavirus vaccine surrogates that could then be applied by pharmaceutical companies to produce vaccine stockpiles enabling more rapid response to future viral outbreaks.

For more information, contact:

William Kessler
Vice President, Applied Optics
kessler@psicorp.com
Physical Sciences Inc.
Telephone: (978) 689-0003