Scalable nanomedicine platform for mRNA, LNP, and continuous nanoformulations

A nanoparticle-based platform for future healthcare solutions

Fraunhofer IMM develops scalable platforms for the continuous production, purification, and analysis of nanoformulations, including mRNA/LNP systems. Our technology combines microreactor technology, tangential flow filtration, and inline DLS to enable reproducible process development from screening through scale-up.

 

Offer to our customers


Our Research and Development Services

  • Scalable mRNA formulation system for screening and process development
  • Process development for the continuous production of micromixer-based nanocarriers
  • Versatile nanoparticle systems for therapeutic and diagnostic applications
  • Optimization and implementation of (inline) nano- and bioanalytics
  • Sample analysis, protocol support, and scientific consulting

Our Core Competencies

  • Formulations (e.g., polymer/lipid nanoparticles, liposomes/lipoplexes, and niosomes/polymersomes)
  • Hybrid extracellular vesicle technology
  • Downstream bioprocessing
  • Magnetic particle imaging (MPI)
  • Hyperthermia (magnetic fluid hyperthermia)

 

 

PATENTS           PROJECTS          Further Information    

Equipment

Featured inhouse laboratory instruments
(patented technology)

  1. Inline dynamic light scattering (DLS) – DLS on Flowing Dispersions (DE102016212164B3)
  2. Microfluidic Liposome Production (DE102020214601A1)
  3. Inline Magnetic Particle Spectroscopy (MPS) (developed in cooperation with the German National Metrology Institute - PTB)
  4. Micro-TFF – Tangential flow filtration for minimal sample volumes - patent submitted 20.12.2024

 

Other devices

  1. Sunscreen - LNP Formulation screening device for various nanoformulations
  2. Stunner AF – High-throughput characterization of nanoformulations using DLS, UV/VIS, and fluorescence
  3. NanoFCM Flowanalyzer - Flow cytometry for the analysis of individual nanoparticle populations
  4. 5200 Fragment Analyzer - Capillary electrophoretic analysis and sizing of DNA/RNA fragments
  5. Spark® Multimode Microplate Reader - Versatile reader for absorption, fluorescence, and luminescence assays
  6. Liberty Blue 2.0 Microwave peptide synthesizer
  7. Zetasizer Ultra - Dynamic light scattering (DLS)
  8. 1260 Infinity II/6530 Q-TOF LC/MS
  9. 1260 Infinity II GPC/SEC
  10. CPS DC24000UHR High-resolution disc centrifuge
  11. Spark® Multimode microplate reader
  12. Libra® 120 - Transmission electron microscopy (cryo-TEM)
  13. Expression-L Compact Mass spectrometer with APCI / ESI

 

 

Projects

1. NEXTGENMEDINKUBATOR  - The modular biological laboratory in a container

In collaboration with the ERDF-REACT program, we are driving innovation through the miniaturization and automation of process steps to improve integration capabilities within complex workflows and enable a seamless transition to container-based concepts. Our modular container-based biolaboratory offers flexible solutions for biotechnology startups and enables faster implementation of biotechnological processes.

to project page

 

2. RNAuto  - Automated production technologies for mRNA-based vaccines and gene and cell therapies

Globally, the lack of GMP-compliant production facilities and mature production technologies for innovative nanomedicines and cell therapies poses significant challenges for the healthcare system. To expand the use of mRNA-based vaccines for future pathogens and promote the application of mRNA-based tools for personalized medicine, such as gene and cell therapy, it is essential to remove these barriers. Our goal is to develop automated and digitally supported production technologies for faster, safer, and more reliable processes for mRNA-based nanomedicine that meet pharmaceutical manufacturing standards.

Duration: January 1, 2022 – December 31, 2025

to Flagship project RNAuto

 

3. BioTherNa  - Biomimetic thermoresponsive nanomaterials for more effective cancer therapies

Tumor cells typically have a temperature that is about 1–2°C higher than that of the surrounding tissue. By encapsulating potent drugs, we can deliver these cancer medications directly to their target. The shells are made of a temperature-controllable material inspired by a biomimetic concept and modeled after the completely natural process of the double helix of DNA strands. This approach is intended to be more compatible with conventional chemotherapy through targeted and controlled release.

Duration: October 1, 2020 – March 31, 2026

 

 

4. KmR - KONSORTIUM mRNA

The consortium, funded by the BMWK, focuses on improving production capacities as well as on the research and development of specialized lipids and other excipients for mRNA-based drugs. In particular, we contribute our expertise in formulation technology and specialized nanoanalytics to develop microtechnological formulations. This also includes the scalable production of novel lipid- and polymer-based delivery systems for mRNA administration and theranostic systems.

Duration: January 1, 2023 – June 30, 2027

to Consortium mRNA

 

5. SFB 1552: Material design through defect inspection

The exploitation of “defects” is crucial, for example, to the functioning of semiconductors or the properties of mechanical components. In contrast, the effects of such defects have been scarcely studied in colloid science. This question is being investigated in an interdisciplinary Collaborative Research Center (CRC) funded by the German Research Foundation (DFG), in collaboration with Johannes Gutenberg University Mainz and the Max Planck Institute for Polymer Research. Our goal is to introduce various nanoscale colloids as defects into membranes, to influence and understand their properties and effects, and ultimately to be able to use them in a targeted manner.

Duration: February 1, 2023 – January 13, 2027

to the page of SFB 1552

 

6. HybridCar

The HybridCar project is developing a platform for the production of a hybrid nanocarrier system composed of biogenic and synthetic nanocarriers, designed to enable targeted yet well-tolerated therapy.

Duration: June 1, 2024 – November 30, 2024

 

7. ERDERA (The European Rare Diseases Research Alliance)

ERDERA is co-funded by the European Union and coordinated by the French INSERM. The goal is to improve the health and well-being of the 30 million people living with a rare disease in Europe by making Europe a global leader in research and innovation in the field of rare diseases, thereby providing tangible health benefits to patients with rare diseases through better prevention, diagnosis, and treatment.

With the goal of bringing new effective therapies for rare diseases to market in the EU and beyond, our mission is to advance new types of mRNA nanoparticles such as LNPs, extracellular vesicles (EVs), and biohybrids, and to demonstrate the scalability of targeted and optimized mRNA formulations.

Duration: September 1, 2024 – August 31, 2031

to the alliance page

 

8. Smart-Form – Smart, AI-powered formulation development for effective nanotherapeutics

The Smart-Form project is developing an AI-powered platform to optimize formulation processes for nanomedicines and make them more predictable. The goal is to gain a better understanding of these complex manufacturing processes, which are currently carried out using manual trial-and-error methods. Formulations are analyzed at Fraunhofer IMM, and a comprehensive dataset is created by varying the production parameters. This dataset is processed by Fraunhofer ITWM and integrated into a simulation to make manufacturing more efficient and predictable.

Duration: August 1, 2024 – December 31, 2025

to press release

 

9. ZellPro: Cellular uptake and processing of RNA from LNPs

The KIWI R&D project ZellPro is developing novel lipids and lipid complexes designed to accelerate cellular uptake and ensure high intracellular tolerance for the therapeutics they encapsulate. The new drug delivery systems are designed to recognize specific proteins on the surface of target cells that facilitate the uptake of the drug delivery systems into the cell interior. To achieve this, helper lipids are functionalized with ligands that bind to these specific proteins, thereby improving targeted cellular uptake—i.e., cell specificity.
R&D partners: BioNTech SE, University of Leipzig, Johannes Gutenberg University Mainz, Fraunhofer Institute for Microtechnology and Microsystems, Fraunhofer Institute for Cell Therapy and Immunology, Bioanalytics and Bioprocesses Division

Duration: July 1, 2023 – June 30, 2027

to project page at BMWE

 

10. InnoCar: Innovative hybrid and polymeric carriers as alternatives to lipids

The KIWI R&D project InnoCar is developing and testing new variants of polymeric drug delivery systems for mRNA-based therapeutics. Current mRNA vaccines use lipid nanoparticles to encapsulate mRNA, with the lipids sometimes carrying polymeric chains of polyethylene glycol. These can lead to side effects due to acquired immune system recognition reactions. In InnoCar, new non-immunogenic “stealth polymers” are being developed, which will also lead to increased storage stability. Tissue-specific targeting is to be achieved through appropriate functionalization of these new polymers. A continuous process is being pursued for the encapsulation of mRNA and novel excipients into nanoparticles.

R&D Partners: BioNTech SE, Johannes Gutenberg University Mainz, Fraunhofer Institute for Microtechnology and Microsystems, Fraunhofer Institute for Cell Therapy and Immunology, Bioanalytics and Bioprocesses Division

Duration: January 1, 2023 – June 30, 2027

to project page at BMWE

 

11. NanoMedFutur - Technological innovations in nanomedicine for a successful future in the global fight against cancer

The focus is on the technology transfer of an innovative formulation platform for nanotherapeutics, with the goal of significantly accelerating clinical translation while making it more cost-effective. In addition, scalable and location-independent production concepts are being developed to enable the widespread use of nanomedicine therapies. Through strategic collaborations with industry partners and SMEs, the path to licensing, spin-offs, and successful market entry is being specifically accelerated.

Funded by the Fraunhofer Future Foundation, NanoMedFutur pursues clearly exploitation-oriented goals in line with the “Transfer for Global Challenges” program.

 

Patents

“Thermoresponsive Nanocarrier”

Mixture, aqueous solution containing the mixture, and uses of the aqueous solution. DE Patent, WO Patent Application, Priority 01.03.2022

“Microfluidic Liposome Production”

Method and device for producing a liquid containing liposomes, and produced liquid, DE, EP, CN, IL and US Patent Applications, 19.11.2019

“Dynamic Light Scattering on Flowing Dispersions”

Method for determining the average particle size of particles which are suspended in a liquid and flowing medium, by means of dynamic light scattering, and a device therefore. DE, EP, CN and US-Patent, 04.07.2016

“Single-Core, magnetic iron oxide Nanoparticles”

Method for producing stable dispersible magnetic iron oxide single-core Nanoparticles, stable dispersible magnetic iron oxide single-core nanoparticles and uses of same. EP, US and CN Patent, 18.08.2015

Further information:

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