Cell and Tissue Engineering

Fraunhofer Institute for Interfacial Engineering and Biotechnology

Zellsysteme

Tissue engineering applies the principles of engineering and life sciences with the aim to generate biological substitutes that restore, maintain or improve the function of damaged or affected tissues and organs. For the development of autologous transplants (from patients’ own cells), primary cells are isolated and expanded by appropriate cell-culture techniques until sufficient cell numbers are available for either the colonization of a matrix scaffold structure or for cell therapy. As your competent R&D partner, the Fraunhofer IGB offers the development of tissue engineering products that can be produced according to GMP guidelines.

Competences

  • Isolation and cultivation of primary cells from different tissues and species according to GLP or GMP regulations
    • Micro- or nanostructured (bio)material surfaces
    • Skin, liver, intestine, trachea, cardiovascular tissue
  • Establishing processes to develop three-dimensional organotypical cell cultures as testing model or for tissue reconstruction
    • Biological vascularized scaffold, BioVaSc
    • Tissue-specific computer-controlled bioreactors
    • Vascularized human liver, intestine and trachea model
  • Establishing methods for non-destructive cell and tissue characterization by means of Raman spectroscopy

With the help of these vascularized human test systems, the absorption, distribution, metabolism, excretion and toxicity (ADMET) of substances or medicinal products can be investigated. These parameters are critical in the characterization of the pharmacokinetic and toxicological properties of active substances. Our findings can be extrapolated directly to the human organism, with the consequence that a large number of animal experiments could be replaced.

Another goal is the use of our complex tissues as transplants in regenerative medicine. In our GMP manufacturing unit, we offer process development and manufacturing of autologous transplants (advanced therapy medicinal products, ATMPs) as investigational medicinal products (IMPs). The first step involves establishing and verifying the specific manufacturing process for a particular ATMP, which is then adapted to regulatory demands. The final step is applying for the manufacturing authorization for investigational medicinal products. At present, we possess manufacturing authorization for an autologous cartilage transplant, an autologous stem cell transplant and an autologous blood vessel transplant for bypass surgery.

Services

  • Cell culture technology of primary human cells and of specific cell culture media
    • In vitro testing of biocompatibility according to DIN ISO 10993-5
  • Cell biology analysis
    • Molecular-biological, histological and immunohistological methods
    • Flow cytometry (FACS), including cell sorting
    • Modern digital image processing techniques such as micro-dissection and Raman spectroscopy
  • Establishing of various 3D tissue models
    • Accredited for REACH testing
    • Alternatives to animal testing in cosmetics R&D
    • ADMET testing in substance and drug screening
    • Target screening for new therapeutics and infection biology
  • Development of specific computer-controlled bioreactor systems for the cultivation of vascularized tissue models
  • Process development, manufacturing and testing of cell and gene therapeutics as investigational medicinal products or ATMPs (phase I/II clinical studies)

Infrastructure, laboratory and technical equipment

  • Cell culture laboratories conforming to safety levels S1 and S2 of the German GenTSV (genetic engineering safety regulations)
  • State-of-the-art equipment like inverse fluorescence microscope, FACS,
    and microdissection instrumentation
  • GMP production unit (cleanrooms, separate quality control area, storage facilities)