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H2020Doctoral network2017–2022

A4B · Analytics for Biologics

Horizon 2020 — Marie Skłodowska-Curie Actions

Duration
2017-10-01 → 2022-03-31
EU contribution
€3,933,617
Participants
11
Scheme
MSCA-ITN

Lines connect the coordinator with its partners.

Results in brief

Analytics for Biologics

The market of therapeutic proteins (TPs) is a growing field in the pharmaceutical industry. Production of TPs originates in a mixture of very similar biomolecules, called protein species respectively proteoforms (synonym). Some of these differences can have an impact on stability, half-life, safety, and efficacy of the TP, sometimes with harmful consequences for the patient. Thus, methods for qualitative and quantitative the analysis and purification of TPs are urgently needed as well as specialists in the field of TP manufacturing. In an Europe-wide joint research and training network the graduate school A4B has offered a specific research and training program yielding improved and new methods for analysis and purificaton of TPs as well as the required specialists. Within the joint A4B-project, students focused on the improvement of manufacturing TPs as well as the development of analytical tools for identification and quantification of TP-species (TP-S) and their separation. For controlling effectiveness and design of experiments, especially fast and reliable quantitative methods were developed. The improved and new tools comprise the analysis of many different types of posttranslational modifications (PTMs) including glycans, with which the TPs can be modifed. For this aim, advanced electrophoretic, liquid chromatographic, and mass spectrometric approaches in combination with bioinformatics were applied. The methods developed in the A4B project were used to optimise purification and characterisation of TP-S as well as to study the metabolism of TPs in vitro and in vivo. In summary, the Analytics for Biologics (A4B) ITN was successfully training 15 early-stage researchers (ESRs) to become specialists production, purification and analysis of TP-S. All A4B students received a basic education in manufacturing and marketing of TPS. Through their research projects the students developed in depth expertise in one of the areas covered by the consortium.This project thus generated urgently needed new methods for an improved analysis and purification of TP-S, while at the same time ensuring that well qualified young researchers are available for this rapidly growing area of the pharmaceutical industry.

Data: CORDIS, © European Union

Project objective

Qualitative and quantitative analysis and purification of therapeutic protein species (TP-S) – coded by the same gene, thus chemically often very similar – is one of the most challenging problems in analytical chemistry today. This problem is of huge impact in the area of therapeutic proteins (TPs) – a rapidly growing market – causing a high demand in specialists in the field of TP manufacturing. This demand can currently not be met by single European universities. In an Europe-wide joint research and training network the graduate school A4B will offer a specific training program yielding the required specialists. A4B-PhD students will develop solutions for the most urgent problems in TP production and analysis. Production of TPs is associated with the generation of poorly effective or even harmful species. For an effective removal of these species, A4B-students will develop improved purification methods based on advanced affinity and displacement chromatography. For controlling effectiveness and design of experiments, fast and reliable qualitative and quantitative detection methods are required. The development of these analytical methods will focus on the chemical composition of TP-S including their glycans and other posttranslational modifications (PTMs). We will use high-end electrophoretic, liquid chromatographic, and mass spectrometry approaches in combination with bioinformatics. The developed methods will be tested and used for improving protein production processes and therapy control. All A4B students will receive a basic education in manufacturing and marketing of TPS. Through their research projects the students will develop in depth expertise in one of the areas covered by the consortium. This project will thus generate urgently needed new methods for an improved analysis and purification of TP-S, while at the same time ensuring that well qualified young researchers are available for this rapidly growing area of the pharmaceutical industry.

Original text from CORDIS.

Participants

  • UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF · HamburgCoordinatorGermany
  • ACADEMISCH ZIEKENHUIS LEIDEN · LeidenNetherlands
  • ALPHALYSE A/S · ODENSEDenmark
  • EBERHARD KARLS UNIVERSITAET TUEBINGEN · TuebingenGermany
  • HEXAL AKTIENGESELLSCHAFT · HOLZKIRCHENGermany
  • KUNGLIGA TEKNISKA HOEGSKOLAN · StockholmSweden
  • LUDGER LIMITED · AbingdonUnited Kingdom
  • RIJKSUNIVERSITEIT GRONINGEN · GroningenNetherlands
  • SYDDANSK UNIVERSITET · Odense MDenmark
  • UNIVERSITAET FUER BODENKULTUR WIEN · WienAustria
  • UNIVERSITETET I OSLO · OsloNorway

Links

Data: CORDIS, © European Union