Fraunhofer Institute for Cell Therapy and Immunology IZI
Fraunhofer Institute for Cell Therapy and Immunology IZI

Automated production technologies for mRNA-based drugs

Lipid nanoparticle formulation and characterization for nanotherapeutic applications

© Fraunhofer IMM

Formulation

  • Scalable formulation system for screening and process development for nucleic acid encapsulation
  • Process development for continuous manufacturing of micromixer assisted nanocarriers
  • Versatile nanocarrier systems for therapeutic and diagnostic applications
Schematic overview of automated synthesis of different nanocarrier and their characterization
Automated synthesis of different nanocarrier and their characterization.

Characterization

Physicochemical analytical methods:

  • Determination of size 
  • Size distribution
  • Zetapotential
  • Morphology (cryo-TEM)
  • Encapsulation efficiency (Ribogreen Assay, HPLC)
  • RNA integrity testing (Fragment Analyzer)
  • Lipid analytics (LC-MS)
© Fraunhofer IMM
Cryo-TEM image of lipidnanoparticles.
© Fraunhofer IMM
Cryo-TEM image of liposomes.
© Fraunhofer IMM
Cryo-TEM image of coated magnetnanoparticles.

In vitro evaluation

Using your desired cell type (human cell lines as well as primary human cells) we can analyze:

  • Toxicity of the nanocarriers
  • Transfection efficiency using reporter genes
  • Transgene expression (potency) in various cell lines and primary human immune cells
Schematic overview of in vitro evaluation process

In vivo evaluation

Having several animal study approvals, we can offer:

  • Biodistribution studies and tissue targeting using reporter genes in wild type mice
  • Immune cell targeting in humanized mice
Schematic overview of in vivo evaluation process

Relevant publications

  • Bär C, Blache U, Tretbar US (2025). Advanc­ing mRNA-Based Cell Therapies: The Crucial Role of mRNA Optimization for therapeutic efficacy. Viewpoint Article, Nucleic Acid Insights 2025; 1(2), 1–5, doi: 10.18609/nuc.2025.001
  • Kitte R, Serfling R, Blache U, Seitz C, Schrader S, Köhl U, Fricke S, Bär C, Tretbar US (2025). Optimal chimeric antigen receptor (CAR)-mRNA for transient CAR T cell generation. IJMS, Volume 26,  Issue 3, doi: 10.3390/ijms26030965
  • Kitte R, Rabel M, Geczy R, Park S, Fricke S, Koehl U, Tretbar US (2023). Lipid Nanoparticles outperform Electroporation in mRNA-based CAR T cell Engineering. Molecular Therapy – Methods and Clinical Development, 31, 101139, doi: 10.1016/j.omtm.2023.101139

Industrial collaboration & partnering

  • Development and testing of mRNA nanoformulations
  • Customized building of formulation and analytic modules
  • Technology transfer and licensing
  • Protocol assistance 
  • Scientific consulting