PEG-Lipid Nanoparticles in the Development of mRNA Vaccines

The COVID-19 pandemic brought the importance of scientific research into sharp focus as scientists worked (and still work) tirelessly to develop effective vaccines and treatments to combat the virus and protect lives. A promising breakthrough in this pursuit has been the development and scale-up of lipid nanoparticles to deliver mRNA vaccines into cells. The success of this approach hinges on the stability of the lipid nanoparticles, emphasizing the importance of how the PEG-lipids are developed.

PEG (polyethylene glycol) is a hydrophilic synthetic polymer that is often used to aid the solubility and circulating half-life of therapeutics or vaccines by conjugating or modifying the surface of poorly soluble motifs or carrier transport molecules such as lipid nanoparticles. Prior to COVID-19, most pegylation methods were performed at small scale without sufficient characterization or control of process parameters that would enable rapid process scale-up.  

As the COVID-19 pandemic progressed, pharmaceutical companies, CDMOs, and CROs relied on METTLER TOLEDO solutions to speed up the development of PEG-lipids. Our products provided high-quality data the chemists needed to better understand their process, allowing them to complete investigations more quickly. Bioprocess reactors and integrated process analytical technology (PAT) helped scientists and engineers scale up from research and clinical-scale to large-scale production, which was essential during the urgent development of mRNA vaccines. 

EasyMax™ synthesis workstations aided in obtaining valuable data on chemical reactions, optimizing processes, and reducing development times. The use of ReactIR™ in-situ FTIR provided real-time analysis of batch and flow reactions, while EasySampler™ enabled automated and robust inline methods for taking representative samples from reactions during overnight experimentation. ParticleTrack™ with FBRM® technology and EasyViewer™ inline microscopy were used to obtain insight into particle size, shape, and count. In addition to these solutions, METTLER TOLEDO iC Data Center was implemented by many to further streamline the research process through improved data capture, management, and analysis.

The success of the PEG-lipid project has been a critical breakthrough in the fight against COVID-19, and the deployment of cutting-edge equipment and digitalization solutions at R&D sites has set the stage for further collaboration. This partnership between industry and technology providers highlights the crucial role that innovation can play in advancing scientific research. As the broader healthcare field addresses new and ongoing challenges, investments in similar technologies will be vital to overcoming them. METTLER TOLEDO remains committed to providing products and solutions that help scientists and researchers make a real difference in the world.

Driven by need, innovation, and emerging regulatory guidance, the biopharmaceutical industry is adapting new downstream bioprocessing techniques. This guide discusses how scientists are utilizing Process Analytical Technology (PAT) to transform day-to-day workflows and make significant downstream process improvements.