Drug development

In drug development, we create human test systems that already allow statements to be made in preclinical research about the effect and side effects of potential highly specific drug candidates that cannot be provided in animal models. We achieve this by developing organoid in vitro models, from three-dimensional in vitro models of human tissue to organ-on-a-chip systems. Our many years of experience in molecular cell technology enable us to precisely develop receptor-based assays for drug validation as well as production cell lines for biologicals.

New innovative therapeutic approaches are developed at the IGB using viruses. Our long-standing experience in virus engineering enables the tailor-made design of viruses for targeted prevention (vaccines) and therapy (oncolytic viruses).

For the targeted transport and controlled release of active substances (drug delivery and release), we formulate active substances, for example, in a matrix consisting of biobased, polymeric or silicate materials.

Screening systems

Often the cause of a disease lies in a faulty interaction of the body's own molecules, for example due to altered receptors or enzymes, which play a decisive role in the cellular signal chains. Knowledge of the altered cellular target structures is therefore essential for a therapy that starts at the cause.

 

Drug screening and validation with immune receptors

The innate immune system has a great influence on the course of allergies, infections, tumors or autoimmune diseases. Central regulators of the innate immune system are different classes of immune receptors. Agonists and antagonists of these immune receptors therefore represent a new therapeutic approach for immunotherapy: Receptor agonists stimulate the innate immune system, while antagonists inhibit inflammatory processes.

Based on its own patents, Fraunhofer IGB has developed various screening systems, from simple cell-based assays to complex human tissue models with components of the immune system. This allows the interaction of different cell types, e.g. in autoimmune diseases such as psoriasis or dermatitis, or host-pathogen interactions to be analyzed at the molecular level. This enables us to identify target structures for the development of antibiotics/anti-infectives or for the modulation of our own immune system. 

Cell-based assay for pyrogen detection.
Cell-based assay for pyrogen detection.

3D tissue models as in-vitro test systems

A large number of drug candidates still fail in the early clinical phases, e.g. due to lack of efficacy or unexpected side effects. This is because even highly developed animal models are not capable of reproducing the complex human body and especially human diseases. Fraunhofer IGB is therefore working on three-dimensional in vitro models and organ-on-a-chip systems based on human cells and tissue, which allow statements to be made about effects and side effects in preclinical research and can replace animal experiments. Organ-on-a-chip systems combine the features of classical cell assays (human genes) and animal models (3D tissue and blood circulation) and offer the possibility of reducing animal experiments and increasing the significance of preclinical results according to the 3R principle (Replace, Reduce, Refine). We characterize potential active ingredients in vitro using complex 3D models of both "healthy" and "diseased" tissue.

Organ-on-a-Chip.
© Bernd Müller / Fraunhofer IGB

Production cell lines for biologicals

For the production of pharmaceutical proteins, we develop processes ranging from the establishment of new expression vectors to strain development in microorganisms and mammalian cells, the optimization of fermentation processes and the purification of pharmaceuticals. We offer the GMP-compliant production of clinical test products through a cooperation in the Fraunhofer-Group for Life Sciences. The first generic biologicals such as beta-interferon as well as proprietary developments such as Soluferon are already on the market or have been out-licensed using processes developed at Fraunhofer IGB.

Virus engineering

New innovative therapeutic approaches are being developed at the IGB using viruses. Our many years of experience in virus engineering enable the tailor-made design of viruses for targeted prevention (vaccines) and therapy (oncolytic viruses).

Using PCR technologies, we have also developed a rapid test for the detection of viruses based on nucleic acids, a nucleic acid-based lateral flow assay.

Plaque formation by green fluorescent HSV1 viruses.
Plaque formation by green fluorescent HSV1 viruses.

Drug delivery and release

A decisive factor in the development of functional ingredients or active substances is the transport of the substances to their destination, for example into a tissue or cell. The Fraunhofer IGB is working on materials and structures that transport substances to their target (drug delivery) and release them there in a controlled manner (drug release).

 

Formulation and release systems for active substances

For example, we develop matrices from biobased, polymeric or silicate materials in the form of (nano-)particles or layers. Spray drying is used to encapsulate active ingredients and effect substances in (bio)polymer-based materials. By chemical modification, the release properties can be adjusted and customized.

Chitosan particles.
© Fraunhofer IGB