Modules
Module 1: Advanced separation materials
The goal in this module is the development of advanced separation materials for analytical and preparative scale chromatography in various application areas such as pharmaceutical chemistry, clinical, toxicological and biomedical analysis, as well as proteomics and metabolomics research. The primary focus is to develop dedicated functionalized microparticulate and monolithic materials with new improved and more flexible selectivity profiles. This can be accomplished, for example, on the basis of chemoselectivity principles by the combination of specific molecular recognition increments. The new materials should have, in particular, enhanced separation capabilities for polar substances like hydrophilic peptides, exogenic and endogenic human metabolites, as well as plant metabolites. Besides broader application spectra and more flexible selectivity adjustment enhanced loading capacities in preparative scale chromatography is another optimization goal for the new separation media. The project includes the devising and delivering of protocols how to optimally use these materials, as well as their testing in real applications such as bioanalytical studies or preparative scale chromatographic purification of e.g. synthetic or biotechnologically synthesized peptides. The industry partner is Merck KGaA.
Module 2: Chiral recognition
The majority of modern drugs are chiral and exist as pair of enantiomers (stereoisomers). The opposite enantiomers may exhibit significantly different pharmacological and toxicological profiles. Moreover, they are indistinguishable in achiral environments such as common reversed-phase HPLC systems. To be able to recognize and separate the individual enantiomers of a racemate or a non-racemic mixture, chiral stationary phases which carry effective chiral selector moieties are needed. Such chiral stationary phases are designed and synthesized in the CD-laboratory. From the scientific viewpoint, the project includes also the investigation of the underlying chiral recognition and enantioselective separation mechanisms. The peculiarity of the chiral stationary phases that are developed in the CD-laboratory is their action by an enantioselective ion-exchange process. The fact that drugs usually contain ionizable functional groups makes this concept most qualified for the intended purpose. Enantioselective separation methods have received extraordinary importance in drug discovery and are nowadays indispensable in modern drug research both from an analytical and preparative perspective. The industrial partner of this module is the pharmaceutical company AstraZeneca.
Module 3: Biochromatography
Biopharmaceuticals such as hormones, blood coagulation factors, therapeutic vaccines or antibodies belong to the segment in pharmaceutical industry that shows an above-average growth. As a matter of fact a bright future is predicted for these pharmaceutical products. Unfortunately, their production is associated with high costs not least due to the highly demanding purification strategies. These proteinogenic biopharmaceuticals are produced by biotechnological processes and it is common to use chromatographic processes for product capture and purification of the cell supernatant that contains, besides a variety of other components, the target protein in highly diluted form. Together with Merck KGaA, specifically functionalized organic polymer based separation media are to be developed, which act by chemoaffinity principles and exhibit selectivity as well as enhanced binding capacities for the target protein classes. This module is focused in particular on the delivery of advanced separation materials for glycoproteins and antibodies.
Module 4: Amino acid and peptide analytics
The goal of this module is to provide concepts and methods for a comprehensive analysis of amino acid and peptide samples from stability testings of an amino acid drug formulation for parenteral nutrition. The developed analysis methods should allow to establish a comprehensive qualitative and quantitative impurity profile. This is a challenging task and requires multidimensional analysis concepts as well as hyphenation with advanced detection systems such as tandem mass spectrometry. The project has mainly an analytical focus and should provide the information on the stability of the drug formulation. Such data are required by the industry partner Fresenius Kabi Austria for the approval of the formulation.
