Booklets and Flyers

Integrated Production Platforms

© Fraunhofer IME

Biotechnology is a key 21st century technology. As such, biotechnological products are already changing our lives, for example as active pharmaceutical ingredients (APIs) in new medicines that facilitate the treatment of challenging diseases such as cancer. The number of such biopharmaceuticals has increased over the last years, accounting for about 30% of all new medicines approved by the regulatory authorities. But before any such medicines enter the market, they must undergo an extensive development process comprising API design, proof of concept, process development and scale up, production under good manufacturing practice (GMP) conditions, clinical trials and regulatory approval. Although such processes may involve different steps and unit operations, they all trace back to acommon origin: a brilliant idea for a new API.

Process Development

© Fraunhofer IME

Recombinant proteins are widely used in the life sciences and reliable production options are required. Researchers may need proteins for characterization, animal experiments or for analytical or diagnostic tests. At some stage, it will always be necessary to scale up production and develop a reproducible process to provide sufficient product quantities for extended testing, e.g. clinical studies. The department IPP as part of the Fraunhofer IME offers diverse contract research and development services in this sector, including process design and scale-up.

GMP-Compliant Production of Biopharmaceuticals

© Fraunhofer IME | Stephan Hellwig

The development of powerful tools in life sciences research and the enormous increase in screening capacity for novel therapeutics have fueled a dramatic rise in the number of biopharmaceutical candidates in the development pipelines of global players and SMEs. APIs must be produced according to good manufacturing practice (GMP) for clinical trials. As soon as proof-of-principle for a drug candidate has been established and a molecule is needed in milligram to gram quantities for characterization and preclinical testing, production process development begins to ensure the API is produced with sufficient quality (e.g. purity) at an acceptable scale and cost while complying with regulatory requirements.

Applied Ecology News

© Fraunhofer IME | Photo: MEV-Verlag

2018

Contamination of food by chemical substances results from transfer processes. We explore such processes by carrying out a large variety of studies. To elucidate the transfer of fluorinated alkyl substances via feeding material into animal products we develop methods aiming at their total detection. For the prediction of metabolites originating from pesticides and reaching farmed fish via feedstuff we have developed a method to replace animals. In addition, we describe how we improve the determination of the degrading behaviour of chemicals in soil by investigating the reliability of recording experimental conditions.We also introduce Dr. Kerstin Derz, Deputy Head of the Department Ecological Chemistry.

© Fraunhofer IME | Photo: Klaus Peter Kappest

2017

Analyzing the environmental risk of chemical substances and assessing the quality of environmental media – these are key tasks of the Applied Ecology Division at Fraunhofer IME. In this issue we present a novel test system for sensitive lotic invertebrates and a new method to prove the occurrence of Anticoagulant Rodenticides in German inland waters using a multi-method developed for the German  Environmental Specimen Bank. Taking wastewater treatment as an example we explore whether the chemical composition of nanomaterials can give a hint on their ecotoxicity. We also introduce Matthias Teigeler, head of our worldwide recognized fish laboratory.

© Fraunhofer IME | Photo: Walter Pfliegler

2016

Chemicals reach the environment via production, transport, use and disposal of consumer products. From there they find their way into raw food materials. The limits of detection are continually decreasing, more and more substances can be identified in increasingly smaller concentrations. Acting as a mediator between industry and regulatory bodies we are involved in the development of many international test procedures for substance evaluation. In this first issue of the Applied Ecology Newsletter we present some of these activities. We also introduce Dr. Burkhard Knopf who retrospectively identifies substance
concentrations in the framework of the German Environmental Specimen Bank.

Higher Tier Aquatic Risk Assessment

© Fraunhofer IME | Klaus Peter Kappest

Standard risk assessments are designed to be protective and are not necessarily realistic. There are several options to refine these assessments using higher tier studies. We design and execute such studies under GLP conditions, assessing aquatic effects in order to provide more realistic effect data and reduce the uncertainties in extrapolation to a field situation. Necessary fate and exposure analysis is conducted in close co-operation with our chemical departments in-house.

Nanomaterials - Behavior, Fate and Effects

© Fraunhofer IME | Klaus Peter Kappest

Nanomaterials are capturing the European market in a rapidly increasing number of products, available both for industry and private consumers. They offer a wide spectrum of technical and commercial  opportunities, e.g. as ingredients of foods, pharmaceuticals and cosmetics. Evidence published in scientific literature during the past few years, however, suggests that some nanomaterials, due to hazardous properties, might give reason for health and safety concerns with regard to humans and organisms in the environment. While draft guidance of competent authorities is still under development, we are able to provide a full spectrum of experimental methods to test and assess the behavior, fate and effects of nanomaterials in a way that fully complies with regulatory requirements.

Fraunhofer-Allianz Food Chain Management

© Thorwald Hoffmann

Food enterprises compete in a tough market environment. The safeguarding of secure and sustainable food becomes more and more challenging in times of complex global flow of foods. The customers seek safe and healthy food in good quality and at a favourable price. However, even today, about 30 percent of the global produced food is spoiled during transport. Emerging trends in the food sector target faster food supply times requiring highly efficient logistics for fast handling

Booklets of the Fraunhofer Society

© Fraunhofer IME | Peter Müschen

Booklets of the Fraunhofer Group for Life Sciences

© Fraunhofer IME | Peter Müschen