Expertise

Overview of the expertise pooled in the Fraunhofer CIMD

Biomarker analysis and development

  • Biobank
  • Biopsies (synovia, pleura, liquid biopsy)
  • Cell isolation
  • Proteome, metabolome, and lipidome analyses
  • Epigenetics
  • Sequencing
  • Next-generation cytometry
  • Biosensors
  • Single-cell diagnostics
  • Omics platforms
  • LC-MS/MS analyses 

Lead discovery

  • Cryo-electron microscopy
  • Multi-epitope ligand cartography
  • Next-generation cytometry
  • Mass spectrometry
  • Cell-based assays
  • High-throughput screening
  • Drug design
  • Medicinal chemistry 

 

Treatment concept

  • Development planning and target product
  • Profiles of innovative concepts and products
  • Cost efficiency
  • Genetically engineered cell therapy
  • Therapeutic antibodies
  • Nucleic acid-based therapy
  • Chemically defined therapeutics
  • Vaccination
  • Omics technologies
  • CyTOF technologies

 

 

Preclinical development

  • Cell-based human in-vitro systems (e.g. lab on a chip, 3D tissue models)
  • Human organotypic systems (e.g. ex-vivo tissue cultures)
  • Animal models (e.g. CRISPR/Cas9-based)
  • Zebra fish models
  • Insect models
  • Imaging techniques
  • Bioanalytics
  • GLP testing (safety pharmacology, toxicology) 

GMP manufacturing

  • Process development and GMP-compliant manufacturing (e.g. biopharmaceuticals, cell and gene therapeutics, candidate drugs, master and working cell banks)
  • Formulation, sterile fill and finish
  • Low-energy electron irradiation
  • Quality assurance 

Performance of phase-I and phase-II trials

  • Clinical research center
  • Acting as a sponsor
  • Phase-I units
  • Proof-of-concept studies, phase-I/phase-II trials, phase IV trials
  • Patient and volunteer database
  • Clinical project management
  • Clinical pharmacology
  • Regulatory Affairs
  • Pharmacovigilance
  • Biostatistic
  • Data management

 

Marketing authorization

  • Regulatory expertise from the preclinical stage to market entry
  • Health technology assessment and AMNOG processes

Early Diagnosis and Individualized Treatment of Immune Diseases

Our brochure gives you an insight into the work of the Fraunhofer CIMD: We present the indication area of immune diseases, our bundled expertise, the path from medical need to new drugs and our biobanks.

From medical need to novel medication

© Fraunhofer CIMD

The development of a new drug must follow a multi-stage process that is required by law. On average, it takes more than 13 years from the initial idea to the first marketing approval. Most of this time is spent on studies to test the drug's efficacy and tolerability and to determine the most appropriate dosing protocol.

Biobanks: high-quality biomaterials

© Fraunhofer IME

High-quality biomaterials are essential for conclusive, unbiased medical research. In the context of immune-mediated diseases, the collection of such materials is often a limiting factor. The biobanks of Fraunhofer IME, Fraunhofer IZI and Fraunhofer ITEM store blood, tissue, stool and urine samples. These biomaterials can be used for research purposes whenever needed.

We have access to the following biomaterials from patients via our institutes’ biobanks:

Diagnoses

  • Ataxia teleangiectasia
  • Asthma (LPS challenge)
  • Asthma (rhinovirus challenge)
  • Chronic inflammatory bowel disease
  • COPD GOLD 1-4
  • Eosinophilic fasciitis
  • Lupus erythematosus
  • Granulomatosis with polyangiitis
  • Psoriatic arthritis
  • Psoriasis vulgaris
  • Rheumatoid arthritis
  • Rhinitis
  • Sarkoidosis
  • Spondyloarthritiden
  • Systemic sclerosis
  • Tumor

Samples

  • Bronchoalveolar lavage
  • Citrate plasma
  • DNA, RNA
  • EDTA whole blood
  • Skin biopsies
  • Heparin plasma
  • Lung biopsies
  • Nasopharyngeal lavage
  • PAXgene
  • PBMCs
  • Serum
  • Sputum
  • Stool, urine
  • Synovial fluid and synovia (tissue)
  • Cells from BAL (bronchoalveolar lavage), NAL (nasal lavage), and sputum
  • Cell culture supernatant