develops the next generation of protein biomarker assays using a novel type of mass spectrometry-based immunoassays.
SIGNATOPE (SIGNAture epiTOPE) immunoassays are capable of detecting and quantifying protein biomarkers in humans and all pharmacologically relevant model species. Antibodies comprising epitopes of 4 amino acids are the key reagents of SIGNATOPE´s immunoassays. The short epitope allows us to establish quantitative assays for the same protein in different species and for isoforms of protein families. Even immunoassays for notoriously difficult proteins like drug transporters can be established while providing the speed and the sensitivity of an antibody-based method.
|Homo sapiens||NIFLASFVH EYSR|
|Macaca mulatta||NIFLASFVH EYSR|
|Canis familiaris||FTY EYSR|
|Mus musculus||MFMASFLH EYSR|
|Rattus norvegicus||LLFMASFLHH EYSR|
Basically, the proteins of a biological samples are enzymatically degraded down to peptides in optimized sample preparation procedure. Then our proprietary antibodies recognize only a tiny part of the peptide, the signature epitope. Such epitopes have been selected to be identical in human and all pharmacologically relevant model species: Using these antibodies in combination with a species specific isotopic labelled reference peptides we can accurately quantitate the relevant protein biomarker via their peptide surrogate even if they are a little different in every kind. The peptides are then analyzed and quantified by mass spectrometry. Quantities of the protein can be determined indirectly by comparing the signal intensities of the target peptides to heavy isotope labelled standards.
SIGNATOPE’s testing service is offered to the pharmaceutical industry and CROs in three areas:
SIGNATOPE’s core team has more than 30 years of project experience in applied research for clients from industry and public institutions. The team leaders, Oliver Poetz and Thomas Joos, have an excellent network of international pharma partners and academic researchers. Octavian Schatz, a serial biotech entrepreneur, supports the management to implement the business strategy. SIGNATOPE will initially be hosted by the NMI Natural and Medical Sciences Institute, a renowned research institution and high-tech incubator for several successful start-up companies.
Oliver has over 10 years of experience in assay development, antibody generation and characterization. The main focus of his work is the development of multiplexed protein assays, especially immuno-affinity-based proteomics approaches. His team has been awarded a €1.7m GO-Bio grant for a project on novel cross-species assays for organ toxicity biomarkers for use in drug development.
Thomas is Deputy Managing Director of the NMI, which he joined in 1998. He is a board member of numerous distinguished companies and institutions. His excellent contacts with decision-makers in pharma/biotech have helped him to secure industry contracts for the NMI worth more than €5m.
Hannes has designed the antigen selection and epitope analysis software. In addition, he supports the team in the analysis and statistical evaluation of MS data. He is enrolled in an MBA programme at the highly ranked ESB Business School at Reutlingen University and serves as SIGNATOPE’s director of finance/administration.
Michael is a clinical pharmacologist by training and has extensive experience in pharmaceutical drug development from preclinical and clinical development to post-marketing pharmacovigilance. He has been co-leading with Thomas the IMI SAFE-T consortium, that achieved regulatory support for sets of new safety biomarkers for drug-induced kidney, liver, and vascular injury. At Signatope, he is providing strategic input and establishing contact to scientific working groups and public private partnerships.