Preclinical research and testing

Bringing your drug candidates into clinic

© Photo Fraunhofer ITEM

Are you looking for assistance in the preclinical development of your drug candidate? We offer a broad spectrum of disease-relevant and toxicology models – no matter whether your aim is to evaluate the pharmacological efficacy of a drug, test substances for toxic side effects, or elucidate the fate of large or small molecules, cells, or tissues in the organism. Our special focus is on providing assistance and consultancy services in the development of preclinical and clinical concepts.

Our outstanding expertise, many years of experience with partners from the biotech and pharmaceutical industries, and state-of-the-art equipment form the basis for our scientific solutions and custom-tailored services. In addition, we assist our clients in developing preclinical testing strategies aimed at ensuring regulatory acceptance.

Different cooperation schemes can be offered: Are you seeking a partner for a joint publication, or do you need a particular service to advance your product to the next development phase? Please do not hesitate to contact us.

Efficacy

We offer disease-relevant models for efficacy testing of drug candidates in all relevant therapeutic areas (e.g. COPD, asthma, and infection) of respiratory medicine.

Safety

We offer toxicology, toxicokinetic, and safety pharmacology models for risk assessment and registration of drug candidates.

Viable lung slices

© Photo Fraunhofer ITEM

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

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.

Quality assurance

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

© Photo Fraunhofer ITEM

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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