Preclinical research and testing

Developing drug candidates to proof-of-concept

© Photo Fraunhofer ITEM

We offer preclinical studies with a focus on respiratory diseases such as asthma, COPD, infection, and pulmonary fibrosis. For this purpose, we use disease-relevant and toxicological test systems. Our studies are performed by a highly qualified and dedicated team of immunologists, biologists, toxicologists, and technical assistants. Based on our excellent scientific expertise, we assist our clients in the development of preclinical concepts.

Our experience with partners from the biotech and pharmaceutical industries forms the basis for scientific solutions and custom-tailored services. We assist our clients in developing preclinical testing strategies aimed at ensuring regulatory acceptance.

Different cooperation schemes can be offered: from a joint publication to services aimed at advancing a drug product to the next development phase.

 

Our services and expertise

Efficacy testing of (bio)pharmaceuticals:

  • Disease-relevant models for efficacy testing of drug candidates in all therapeutic areas of respiratory medicine: asthma, COPD, infection, fibrosis, and tumors
  • Broad range of cell, tissue culture, and animal models, used to study different disease aspects

Safety and toxicity testing of (bio)pharmaceuticals: 

  • In-vitro, ex-vivo, and in-vivo studies (relevant species, single-dose and repeated-dose)
  • Safety pharmacology (core battery)
  • Special focus on inhalation toxicology and immunotoxicology
  • Testing strategies to accompany clients during scientific advice and registration processes
  • Study performance in compliance with OECD GLP guidelines

 

Your benefits

  • Preclinical tests with a focus on respiratory diseases, supported by a unique infrastructure
  • Broad diversity of disease models for the respiratory tract
  • Use of human tissue samples to improve predictivity of drug efficacy tests and for testing of biopharmaceuticals
  • Quality guaranteed: the institute’s GLP compliance has been continuously certified by the competent authorities since 1991
  • Academic cooperation with the Hannover Medical School and the German Center for Lung Research (DZL), and involvement in numerous publicly funded research projects (German Research Foundation, German Federal Ministry of Education and Research, and European Union)
  • Scientific synergies from in-house expertise, including GMP manufacturing of investigational medicinal products, preclinical testing, and toxicology

Examples of testing models

Viable lung slices

We frequently use viable lung tissue slices, also referred to as precision-cut lung slices (PCLS), to test the efficacy of a drug candidate. This model is particularly suitable for issues of translational medicine: Is the target relevant in the disease model? Does the drug substance exhibit a disease-relevant effect in human tissue? What species is suitable for further in-vivo testing?

We can thus help you make the right decisions – based on human data – in your drug development process; in some cases even prior to the actual preclinical phase.

Human lung tissue for research on respiratory diseases

© Photo Fraunhofer

© Photo Fraunhofer

The P.R.I.T.® ExpoCube® system: Testing of inhalable medicinal products for biological effects

When testing inhalable pharmacological substances for biological effects, it is of pivotal importance to take into consideration the relevant route of exposure, which is via the lung. Using the P.R.I.T.® ExpoCube® system, Fraunhofer ITEM is able to test active pharmaceutical ingredients in their relevant form of administration in different in-vitro or ex-vivo test systems from human lung.

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Our quality standard

Our scientifically founded approach enables accelerated and reliable drug development, including quality assurance according to GXP guidelines. Based on the principles of Good Laboratory Practice (GLP), we have implemented a quality assurance program that guarantees validity of the data generated in our toxicological, safety pharmacological, and analytical departments.

more information about it: Quality assurance