RNA-LNPs

iATMP/prophylactic vaccine consisting of (m)RNA encapsulated in lipid nanoparticles (RNA-LNPs).

Manufacturing Process

RNA-LNPs are generated through microfluidic mixing of RNA and lipids with NanoAssemblr Ignite+ nanoparticle formulation system. Subsequently, buffer is exchanged and the RNA-LNPs are concentrated through tangential flow filtration with the KrosFlo® system. Finally, the RNA-LNPs are sterile filtered and filled out in glass vials and frozen down at -80°C.

Quality control tests in place: Appearance, sterility, endotoxins, RNA content, encapsulation efficiency, RNA integrity, size, polydispersity, zeta potential, pH, osmolality, residual solvents, residual ethanol, lipid content and identity

Projects

Galsome-Neo

Glycolipid-adjuvanted mRNA lipid nanoparticle cancer vaccine.

Service: Tech transfer, IMPD writing, Manufacturing, QC for toxicity study and phase I clinical trial

Collaborators: Dr. Ine Lentacker, Dr. Rein Verbeke, Dr. Ine Lentacker, Dr. Rein Verbeke, Prof. dr. Stefaan De Smet, Prof.dr. Karim Vermaelen, Dr. Dieter Stevens, Prof.dr. Diether Lambrechts, Prof. Dr. Jeroen Dekervel

Ongoing

Galsome-NEO is a glycolipid-adjuvanted mRNA lipid nanoparticle (LNP) cancer vaccine encoding neo-epitopes for evaluation in a phase 1 study in patients with non-small cell lung cancer. The inclusion of the glycolipid adjuvant, alpha-galactosylceramide (α-GC), within the LNPs not only activates T cells but also engages invariant natural killer T (iNKT) cells, thereby eliciting a multi-faceted anti-tumor immune response.

The Nanomedicine lab at the University of Ghent has developed a glycolipid-adjuvanted mRNA vaccine. The development of the manufacturing process, the manufacturing and QC of the batch for toxicology, was done at the GMP unit of UZGent.

Preclinical toxicological assessment of an α-galactosylceramide-adjuvanted mRNA cancer vaccine in Wistar Han rats and domestic pigs

Meulewaeter S. et al. Mol Ther Methods Clin Dev 2025

In this study, a preclinical toxicological assessment of an α-galactosylceramide-adjuvanted mRNA cancer vaccine in Wistar Han rats and domestic pigs was conducted as a critical step in advancing toward the phase 1 clinical testing of Galsome-NEO.

Read the publication

Baxerna

Next-Generation Bacterial mRNA Vaccines

Service: CellGENTherapies will be responsible for the production and QC of a mRNA drug substance, and mRNA-LNP drug product batch for a toxicity study and a first-in-human clinical trial.

Ongoing

The project BAXERNA 2.0 will establish a new vaccine development pipeline that relies on breakthrough technologies for the development of novel mRNA-LNP vaccines against Mycobacterium tuberculosis (MTB), Mycobacterium ulcerans (MU), and Acinetobacter baumannii (AB). The new pipeline will overcome current limitations in vaccine development, namely a lack of known antigens and weak cellular immune responses.

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