JR Centre for Development of Comprehensive Analytical Tools for the Pharmaceutical Industry

The demands on analytics in the pharmaceutical industry are high. This JR Centre researches analytical methods that cover all stages of the production chain as well as the interaction of the finished product with the drug packaging.

Analysis plays an important role in the development of pharmaceutical products at various levels. For example, the exact composition of all starting materials and all current product batches must be known precisely.

Information on the structure of product impurities, which can arise e.g. through degradation of the active ingredient, is essential for efficacy and health safety and can only be generated using complex analytical detection methods.

The high standards of analytics are defined by the International Committee on Harmonisation (ICH) and the national and international regulatory authorities and must be demonstrated with every new marketing authorisation submission. This applies to both original pharmaceutical development and the development of generics.

The aim of this JR Centre is to develop a comprehensive screening platform for starting materials, process intermediates, the finished drug product and process- or degradation-related impurities, which enables the identification of specific quality markers in the development of pharmaceutical products. Current Directives of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) also require the implementation of innovative analytical procedures in order to meet the increasing requirements with regard to patient safety. This applies in particular to the migration of potentially harmful substances from packaging materials. The analytical methods should therefore also allow the chemical characterisation of polymer-based packaging and process materials, as well as well-founded statements on the interaction of the drug with packaging materials. Corresponding analytical studies should therefore be implemented at the beginning of the drug development process in order to allow sufficient leeway in terms of method design.

The analytical techniques used include complex high-end analytical methods that detect non-volatile, semi-volatile and volatile organic compounds. The knowledge gained serves as the basis for the development of a customised, process-accompanying monitoring system. By systematically improving existing approaches in the area of product development, the corresponding production processes are to be continuously optimised or, if necessary, redesigned at the same time as knowledge is gained in the area of instrumental analysis. This is the only way to guarantee the development of high-quality medicinal products on a scientific basis.