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SIGNATOPE GmbH

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Reutlingen, DE

About SIGNATOPE GmbH

SIGNATOPE develops highly sensitive quantitative protein tests to detect and monitor side effects of new medical entities in early stages of drug development.

SIGNATOPE`s tests are unique, since they function in many different species, covering practically all pharma-relevant animal models. Their use helps... Show more »

SIGNATOPE develops highly sensitive quantitative protein tests to detect and monitor side effects of new medical entities in early stages of drug development.

SIGNATOPE`s tests are unique, since they function in many different species, covering practically all pharma-relevant animal models. Their use helps to speed up pre-clinical development and helps to avoid substantial risks and costs due to a later failure.

Harmful side effects which go undetected until late stages of drug development account for losses that can go into hundreds of millions. Early detection of unwanted effects is therefore imperative for efficient drug development. SIGNATOPE’s tests are suitable to analyze a wide range of biological liquids and tissues from many species used in pharmaceutical research and provide accurate results from minute sample quantities. SIGNATOPE offers a direct assay service to the pharmaceutical industry. Based on proprietary cross species antibodies, we can quantify a multitude of biomarkers in one sample by mass spectrometry. These antibodies bind to signature sequences which are conserved between different species. SIGNATOPE’s clients are R&D departments of pharmaceutical companies.

Perhaps the most valuable USP of SIGNATOPE’s technology platform is the capacity to develop novel custom made assays in a fraction of the time required by traditional Sandwich ELISA tests. This will enable our clients to better characterize their NMEs and consequently make faster progress in their R&D pipelines.

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Our Services (22)


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CYP Induction Assay

Price on request

CYP450-Immunoaffinity LC-MS/MS Potein Quantification

Drugs are predominantly metabolized in the liver. The cytochrome P450 family (CYP) is involved in the oxidative (phase I) metabolism. In the second phase, these metabolites are modified by glucuronosyl- and sulfotransferases (phase II enzymes). Finally they are actively... Show more »

CYP450-Immunoaffinity LC-MS/MS Potein Quantification

Drugs are predominantly metabolized in the liver. The cytochrome P450 family (CYP) is involved in the oxidative (phase I) metabolism. In the second phase, these metabolites are modified by glucuronosyl- and sulfotransferases (phase II enzymes). Finally they are actively eliminated by transporters (phase III). These proteins significantly affect the bioavailability of drugs. Hence, new substances need to be tested for their potential to induce such enzymes and transporters. The FDA recommends using mRNA profiling to assess the induction of cytochrome P450 in preclinical studies.
However, SIGNATOPE offers protein-based assays, because protein levels have a higher predictive value. Our SignaXENO assays allow to measure 100s of samples per week, using less than 20 μg of human hepatocyte material. This is a 50-fold improvement in sample throughput and tissue usage compared to other methods.

Currently we have established assays for quantifying Cytochrome P450 isoforms 1A1, 1A2, 2B6, 2C8, 2C9, 2C18, 2C19, 2E1, 2D6, 3A4, 3A5, 3A7 and CPR. on Protein level

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Quantitative Proteomics

Price on request

Signatope provides project-oriented assay development services to pharmaceutical and academic partners.

More than 150 proprietary antibodies towards short terminal epitopes have been developed so far. This allows us to enrich thousands of different peptides in the digested proteome of a single species. The combination of... Show more »

Signatope provides project-oriented assay development services to pharmaceutical and academic partners.

More than 150 proprietary antibodies towards short terminal epitopes have been developed so far. This allows us to enrich thousands of different peptides in the digested proteome of a single species. The combination of Signatope's antibodies and the high sensitivity and specificity of mass spectrometers allows us rapid assay development by use of quantitative mass spectrometry.

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Immunoassay Development

Price on request

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... Show more »

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.

More than 150 proprietary antibodies towards short terminal epitopes have been developed so far. This allows us to enrich thousands of different peptides in the digested proteome of a single species. The combination of Signatope's antibodies and the high sensitivity and specificity of mass spectrometers allows us rapid MS-based immunoassay development by use of quantitative mass spectrometry.

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In vivo Toxicity Testing

Price on request

Organ Injury

Organ Injury

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Dog Rodents CNS/Neurology Nephrology and Urology Hepatology

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Assay Development

Price on request

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... Show more »

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.

More than 150 proprietary antibodies towards short terminal epitopes have been developed so far. This allows us to enrich thousands of different peptides in the digested proteome of a single species. The combination of Signatope's antibodies and the high sensitivity and specificity of mass spectrometers allows us rapid MS-based immunoassay development by use of quantitative mass spectrometry.

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In vitro Drug-Drug Interaction Studies

Price on request

Drugs (XENObiotics) are predominantly metabolized in the liver. The cytochrome P450 family (CYP) is involved in the oxidative (phase I) metabolism. In the second phase, these metabolites are modified by glucuronosyl- and sulfotransferases (phase II enzymes). Finally they are actively eliminated by transporters (phase III). These... Show more »

Drugs (XENObiotics) are predominantly metabolized in the liver. The cytochrome P450 family (CYP) is involved in the oxidative (phase I) metabolism. In the second phase, these metabolites are modified by glucuronosyl- and sulfotransferases (phase II enzymes). Finally they are actively eliminated by transporters (phase III). These proteins significantly affect the bioavailability of drugs. Hence, new substances need to be tested for their potential to induce such enzymes and transporters. The FDA recommends using mRNA profiling to assess the induction of cytochrome P450 in preclinical studies.
However, SIGNATOPE offers protein-based assays, because protein levels have a higher predictive value. Our SIGNAXENO assays allow to measure 100s of samples per week, using less than 20 µg of human hepatocyte material. This is a 50-fold improvement in sample throughput and tissue usage compared to other methods.

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Safety Pharmacology

Price on request

Safety Toxicology. During the lengthy process of drug development, comprehensive tests need to be carried out to analyse organ toxicity. This includes mandatory tests in different animal species such as rodents and dogs (mainly for liver and kidney toxicity). Such tests must comply with specifications stipulated by the FDA, the... Show more »

Safety Toxicology. During the lengthy process of drug development, comprehensive tests need to be carried out to analyse organ toxicity. This includes mandatory tests in different animal species such as rodents and dogs (mainly for liver and kidney toxicity). Such tests must comply with specifications stipulated by the FDA, the ICH and the EMA. Besides acute toxicity, long-term toxicity, toxicokinetics and pharmacokinetics, and organ toxicity have to be tested to detect potential side effects on the cardiovascular and nervous systems, the lung, liver and kidney.

FDA's Critical Path Initiative and the Innovative Medicine Initiative foster research to identify novel biomarkers that can predict organ damage early on. Tests for such markers are likely to become recommended for the approval of new drugs.

Translational safety biomarkers (SIGNATOX)

SIGNATOPE is currently developing immunoassays for drug-induced kidney and liver injury. The testsystem is the only method capable of quantifying identical protein biomarkers in all species using identical tests in the preclinical and clinical phases. Standardized cross-species assays will streamline test procedures in pre-clinical and clinical development and make cross-validation of different tests obsolete.

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Proteomics Consulting

Price on request
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Custom Proteomics

Price on request
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Toxicity Animal Models

Price on request
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Dog Rodents CNS/Neurology Nephrology and Urology Hepatology

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Pharmacology & Toxicology

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Immunoassays

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Bioanalytical Assays

Price on request

Bioanalytical Assays Services

Bioanalytical Assays Services

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Custom Immunoassay Development

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Proteomics

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Liquid Chromatography Coupled Mass Spectrometry Methods

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Liquid Chromatography Coupled Mass Spectrometry Methods Services

Liquid Chromatography Coupled Mass Spectrometry Methods Services

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Mass Spectrometry

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Mass Spectrometry Services

Mass Spectrometry Services

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Spectroscopy

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Spectroscopy Services

Spectroscopy Services

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Imaging & Spectroscopy

Price on request

Imaging & Spectroscopy Services

Imaging & Spectroscopy Services

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Drug Transporter Quantification

Price on request

Drugs are predominantly metabolized in the liver. The cytochrome P450 family (CYP) is involved in the oxidative (phase I) metabolism. In the second phase, these metabolites are modified by glucuronosyl- and sulfotransferases (phase II enzymes). Finally they are actively eliminated by transporters (phase III). These proteins... Show more »

Drugs are predominantly metabolized in the liver. The cytochrome P450 family (CYP) is involved in the oxidative (phase I) metabolism. In the second phase, these metabolites are modified by glucuronosyl- and sulfotransferases (phase II enzymes). Finally they are actively eliminated by transporters (phase III). These proteins significantly affect the bioavailability of drugs. Hence, new substances need to be tested for their potential to induce such enzymes and transporters.
SIGNATOPE offers protein-based assays for transporters. Our SignaXENO assays allow to measure 100s of samples per week, using less than 50 μg of human hepatocyte material. This is a 50-fold improvement in sample throughput and tissue usage compared to other methods.

Currently we have established assays for BSEP. MATE1. MATE2, MDR1, MRP1, MRP2,MRP3, NTCP, OAT2, OAT3, OAT7, OCT2, SLCO1B1 , & SLCO2B1.

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LC-MS/MS

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In vitro ADME/DMPK Studies

Price on request

In vitro ADME/PK Studies Services

In vitro ADME/PK Studies Services

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