Marie Dekeyrel

Laboratory of Pharmaceutical Process Analytical Technology

Ottergemsesteenweg 460
B-9000 Gent (Belgium) 
Tel.: +32-9-264.8068
E-mail: Marie.Dekeyrel@UGent.be
Education: Industrial Pharmacist (Master in Industrial Pharmacy)

A predictive platform for the fast development of thermostable lyophilized mRNA-lipid nanoparticle vaccines          

mRNA-lipid nanoparticle vaccines demonstrated their effectiveness during the global COVID-19 pandemic. Besides viral applications, mRNA vaccines offer therapeutic potential for protein replacement therapies, cancer immunotherapies, cellular reprogramming, and genome editing. However, the worldwide application of mRNA-lipid nanoparticle vaccines is hampered by instability issues, currently requiring a cold chain for transport and storage. Since these vaccines are particularly susceptible to hydrolysis, lyophilization may provide a solution to ensure their long-term stability.

While traditional batch lyophilization is a time-consuming process, continuous lyophilization offers a more efficient alternative. This technique involves a spin-freezing step, creating a thin product layer over the entire surface of the vial, which significantly reduces drying times.

However, the lyophilization process exposes mRNA-lipid nanoparticle vaccines to various stress conditions such as pH shifts and formation of interfaces between ice and water. Therefore, suitable excipients should be selected to maintain the stability of mRNA-lipid nanoparticle vaccines during lyophilization.

The aim of this project is to develop a predictive platform that streamlines the determination of optimal formulation and process settings for continuous spin-lyophilization of mRNA-lipid nanoparticles. Ultimately, this research can help ensure the accessibility of mRNA-lipid nanoparticles worldwide without the reliance on a cold chain.