Bioanalytische Lösungen für Pharma

Unser umfassendes Angebot an bioanalytischen Dienstleistungen ist auf die spezifischen Anforderungen Ihres Projekts zugeschnitten und unterstützt präklinische und klinische Studien. Unter Einhaltung strenger gesetzlicher Vorschriften bieten wir integrierte Lösungen, die unsere Kunden von der Entwicklung bis zur Zulassung von Arzneimitteln begleiten. Mit unserem fundierten analytischen Fachwissen und modernster Ausrüstung sind wir Ihr zuverlässiger Partner, um mit den neuesten Trends in der analytischen Chemie Schritt zu halten.

Unterstützung bei ADME-, DMPK- und DDI-Studien

Umfassendes Metabolite Profiling
Quantitative Bioanalyse für pharmakokinetische (PK), toxikokinetische (TK), pharmakodynamische (PD), Arzneimittel-Arzneimittel-Wechselwirkungs- und Bioäquivalenzstudien

Identifizierung und Analyse von Biomarkern

Non-targeted Screening (NTS) mit hochauflösender LC-MS
Identifizierung von Metaboliten und geeigneten Biomarkern in Plasma und anderen Matrices
Methodenentwicklung und -validierung in Übereinstimmung mit den ICH M10-Richtlinien zur Validierung bioanalytischer Methoden und Probenanalyse
Transfer und cross-validation proprietärer Methoden

Physikochemische Charakterisierung

Plasmastabilitätsstudien
Identifizierung von Abbauprodukten und Arzneimittelverunreinigungen
Enantioselektive Trennung chiraler Substanzen

Targeted und untargeted Metabolomics

Fortschrittliche non-targeted HR-MS-Workflows für die metabolische Profilerstellung
Quantitative Bestimmung des Fettsäure-/Aminosäurestoffwechsels sowie von Entzündungs- und oxidativer Stress-Biomarkern

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Bioanalytik von Small Molecules

Pharmakokinetik (PK), Toxikokinetik (TK) und Pharmakodynamik (PD) Studien

Metabolite Profiling, Substanzidentifzierung und Strukturaufklärung

Biomarker Analysen

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Unsere Biomarker Methoden

Biomarker	Exposure to	Matrix	Analytical Technique	Reference
11-dehydro-TXB2	Inflammation	Urine	LC-MS/MS	publication February 2012 A simple and robust UPLC-SRM/MS method to quantify urinary eicosanoids Sterz K, Scherer G, Ecker J Journal of Lipid Research, Volume 53, doi: 10.1194/jlr.D023739 publication March 2018 Analysis of Urinary Eicosanoids by LC-MS/MS Reveals Alterations in the Metabolic Profile after Smoking Cessation Goettel M, Niessner R, Scherer M, Scherer G, Pluym N Chemical Research in Toxicology, Volume 31, doi: 10.1021/acs.chemrestox publication October 2018 Identifying suitable biomarkers of biological effects (BOBEs) for evaluating reduced risk products Scherer G, Pluym N, Scherer M CORESTA Congress 2018, Biomarker Workshop, Kunming, China publication October 2017 Metabolomic Fingerprinting in Various Body Fluids of a Diet-Controlled Clinical Smoking Cessation Study Using a Validated GC-TOF-MS Metabolomics Platform Goettel M, Niessner R, Mueller D, Scherer M, Scherer G, Pluym N Journal of Proteome Research, Volume 16(10), doi: 10.1021/acs.jproteome.7b00128. publication January 2018 Review of biomarkers to assess the effects of switching from cigarettes to modified risk tobacco products Peck MJ, Sanders EB, Scherer G, Luedicke F, Weitkunat R Biomarkers, Volume 23(3), doi: 10.1080/1354750X.2017.1419284 publication April 2018 Suitability of biomarkers of biological effects (BOBEs) for assessing the likelihood of reducing the tobacco related disease risk by new and innovative tobacco products: A literature review Scherer G Regulatory Toxicology and Pharmacology, Volume 94, doi: 10.1016/j.yrtph.2018.02.002
2,3-dinor-8-iso-PGF2α	Oxidative Stress	Urine	LC-MS/MS	publication February 2012 A simple and robust UPLC-SRM/MS method to quantify urinary eicosanoids Sterz K, Scherer G, Ecker J Journal of Lipid Research, Volume 53, doi: 10.1194/jlr.D023739 publication March 2018 Analysis of Urinary Eicosanoids by LC-MS/MS Reveals Alterations in the Metabolic Profile after Smoking Cessation Goettel M, Niessner R, Scherer M, Scherer G, Pluym N Chemical Research in Toxicology, Volume 31, doi: 10.1021/acs.chemrestox publication October 2017 Metabolomic Fingerprinting in Various Body Fluids of a Diet-Controlled Clinical Smoking Cessation Study Using a Validated GC-TOF-MS Metabolomics Platform Goettel M, Niessner R, Mueller D, Scherer M, Scherer G, Pluym N Journal of Proteome Research, Volume 16(10), doi: 10.1021/acs.jproteome.7b00128. publication April 2018 Suitability of biomarkers of biological effects (BOBEs) for assessing the likelihood of reducing the tobacco related disease risk by new and innovative tobacco products: A literature review Scherer G Regulatory Toxicology and Pharmacology, Volume 94, doi: 10.1016/j.yrtph.2018.02.002
2,3-dinor-TXB2	Inflammation	Urine	LC-MS/MS	publication February 2012 A simple and robust UPLC-SRM/MS method to quantify urinary eicosanoids Sterz K, Scherer G, Ecker J Journal of Lipid Research, Volume 53, doi: 10.1194/jlr.D023739 publication March 2018 Analysis of Urinary Eicosanoids by LC-MS/MS Reveals Alterations in the Metabolic Profile after Smoking Cessation Goettel M, Niessner R, Scherer M, Scherer G, Pluym N Chemical Research in Toxicology, Volume 31, doi: 10.1021/acs.chemrestox publication October 2018 Identifying suitable biomarkers of biological effects (BOBEs) for evaluating reduced risk products Scherer G, Pluym N, Scherer M CORESTA Congress 2018, Biomarker Workshop, Kunming, China publication October 2017 Metabolomic Fingerprinting in Various Body Fluids of a Diet-Controlled Clinical Smoking Cessation Study Using a Validated GC-TOF-MS Metabolomics Platform Goettel M, Niessner R, Mueller D, Scherer M, Scherer G, Pluym N Journal of Proteome Research, Volume 16(10), doi: 10.1021/acs.jproteome.7b00128. publication January 2018 Review of biomarkers to assess the effects of switching from cigarettes to modified risk tobacco products Peck MJ, Sanders EB, Scherer G, Luedicke F, Weitkunat R Biomarkers, Volume 23(3), doi: 10.1080/1354750X.2017.1419284 publication April 2018 Suitability of biomarkers of biological effects (BOBEs) for assessing the likelihood of reducing the tobacco related disease risk by new and innovative tobacco products: A literature review Scherer G Regulatory Toxicology and Pharmacology, Volume 94, doi: 10.1016/j.yrtph.2018.02.002
8-iso-PGF2α	Oxidative Stress	Urine	LC-MS/MS	publication February 2012 A simple and robust UPLC-SRM/MS method to quantify urinary eicosanoids Sterz K, Scherer G, Ecker J Journal of Lipid Research, Volume 53, doi: 10.1194/jlr.D023739 publication March 2018 Analysis of Urinary Eicosanoids by LC-MS/MS Reveals Alterations in the Metabolic Profile after Smoking Cessation Goettel M, Niessner R, Scherer M, Scherer G, Pluym N Chemical Research in Toxicology, Volume 31, doi: 10.1021/acs.chemrestox publication October 2018 Identifying suitable biomarkers of biological effects (BOBEs) for evaluating reduced risk products Scherer G, Pluym N, Scherer M CORESTA Congress 2018, Biomarker Workshop, Kunming, China publication October 2017 Metabolomic Fingerprinting in Various Body Fluids of a Diet-Controlled Clinical Smoking Cessation Study Using a Validated GC-TOF-MS Metabolomics Platform Goettel M, Niessner R, Mueller D, Scherer M, Scherer G, Pluym N Journal of Proteome Research, Volume 16(10), doi: 10.1021/acs.jproteome.7b00128. publication January 2018 Review of biomarkers to assess the effects of switching from cigarettes to modified risk tobacco products Peck MJ, Sanders EB, Scherer G, Luedicke F, Weitkunat R Biomarkers, Volume 23(3), doi: 10.1080/1354750X.2017.1419284 publication April 2018 Suitability of biomarkers of biological effects (BOBEs) for assessing the likelihood of reducing the tobacco related disease risk by new and innovative tobacco products: A literature review Scherer G Regulatory Toxicology and Pharmacology, Volume 94, doi: 10.1016/j.yrtph.2018.02.002
Leukotriene E4	Inflammation	Urine	LC-MS/MS	publication February 2012 A simple and robust UPLC-SRM/MS method to quantify urinary eicosanoids Sterz K, Scherer G, Ecker J Journal of Lipid Research, Volume 53, doi: 10.1194/jlr.D023739 publication March 2018 Analysis of Urinary Eicosanoids by LC-MS/MS Reveals Alterations in the Metabolic Profile after Smoking Cessation Goettel M, Niessner R, Scherer M, Scherer G, Pluym N Chemical Research in Toxicology, Volume 31, doi: 10.1021/acs.chemrestox publication October 2017 Metabolomic Fingerprinting in Various Body Fluids of a Diet-Controlled Clinical Smoking Cessation Study Using a Validated GC-TOF-MS Metabolomics Platform Goettel M, Niessner R, Mueller D, Scherer M, Scherer G, Pluym N Journal of Proteome Research, Volume 16(10), doi: 10.1021/acs.jproteome.7b00128. publication April 2018 Suitability of biomarkers of biological effects (BOBEs) for assessing the likelihood of reducing the tobacco related disease risk by new and innovative tobacco products: A literature review Scherer G Regulatory Toxicology and Pharmacology, Volume 94, doi: 10.1016/j.yrtph.2018.02.002
Metabolomics (GC)		Urine, Plasma, Saliva, Exhaled Breath	GC-TOF-MS	publication October 2017 Metabolomic Fingerprinting in Various Body Fluids of a Diet-Controlled Clinical Smoking Cessation Study Using a Validated GC-TOF-MS Metabolomics Platform Goettel M, Niessner R, Mueller D, Scherer M, Scherer G, Pluym N Journal of Proteome Research, Volume 16(10), doi: 10.1021/acs.jproteome.7b00128. publication February 2014 Untargeted metabolomic profiling in saliva of smokers and nonsmokers by a validated GC-TOF-MS method Mueller DC, Piller M, Niessner R, Scherer M, Scherer G Journal of Proteome Research, Volume 13, doi: 10.1021/pr401099r
Metabolomics (LC)		Urine, Plasma, Saliva	LC-Orbitrap-MS	publication August 2020 Development of a human biomonitoring method for assessing the exposure to ethoxyquin in the general population Stoeckelhuber M, Scherer M, Bracher F, Peschel O, Leibold E, Scherer G, Pluym N Archives of Toxicology, volume 94, doi: 10.1007/s00204-020-02871-7 publication March 2020 Human metabolism and urinary excretion kinetics of the UV filter Uvinul A plus® after a single oral or dermal dosage Stoeckelhuber M, Scherer M, Peschel O, Leibold E, Bracher F, Scherer G, Pluym N International Journal of Hygiene and Environmental Health, 227:113509, doi: 10.1016/j.ijheh.2020.113509
PGF2α	Oxidative Stress	Urine	LC-MS/MS	publication February 2012 A simple and robust UPLC-SRM/MS method to quantify urinary eicosanoids Sterz K, Scherer G, Ecker J Journal of Lipid Research, Volume 53, doi: 10.1194/jlr.D023739 publication March 2018 Analysis of Urinary Eicosanoids by LC-MS/MS Reveals Alterations in the Metabolic Profile after Smoking Cessation Goettel M, Niessner R, Scherer M, Scherer G, Pluym N Chemical Research in Toxicology, Volume 31, doi: 10.1021/acs.chemrestox publication October 2017 Metabolomic Fingerprinting in Various Body Fluids of a Diet-Controlled Clinical Smoking Cessation Study Using a Validated GC-TOF-MS Metabolomics Platform Goettel M, Niessner R, Mueller D, Scherer M, Scherer G, Pluym N Journal of Proteome Research, Volume 16(10), doi: 10.1021/acs.jproteome.7b00128. publication April 2018 Suitability of biomarkers of biological effects (BOBEs) for assessing the likelihood of reducing the tobacco related disease risk by new and innovative tobacco products: A literature review Scherer G Regulatory Toxicology and Pharmacology, Volume 94, doi: 10.1016/j.yrtph.2018.02.002
Prostaglandin D	Oxidative Stress	Urine	LC-MS/MS	publication February 2012 A simple and robust UPLC-SRM/MS method to quantify urinary eicosanoids Sterz K, Scherer G, Ecker J Journal of Lipid Research, Volume 53, doi: 10.1194/jlr.D023739 publication March 2018 Analysis of Urinary Eicosanoids by LC-MS/MS Reveals Alterations in the Metabolic Profile after Smoking Cessation Goettel M, Niessner R, Scherer M, Scherer G, Pluym N Chemical Research in Toxicology, Volume 31, doi: 10.1021/acs.chemrestox publication October 2017 Metabolomic Fingerprinting in Various Body Fluids of a Diet-Controlled Clinical Smoking Cessation Study Using a Validated GC-TOF-MS Metabolomics Platform Goettel M, Niessner R, Mueller D, Scherer M, Scherer G, Pluym N Journal of Proteome Research, Volume 16(10), doi: 10.1021/acs.jproteome.7b00128. publication April 2018 Suitability of biomarkers of biological effects (BOBEs) for assessing the likelihood of reducing the tobacco related disease risk by new and innovative tobacco products: A literature review Scherer G Regulatory Toxicology and Pharmacology, Volume 94, doi: 10.1016/j.yrtph.2018.02.002
Prostaglandin E	Oxidative Stress	Urine	LC-MS/MS	publication February 2012 A simple and robust UPLC-SRM/MS method to quantify urinary eicosanoids Sterz K, Scherer G, Ecker J Journal of Lipid Research, Volume 53, doi: 10.1194/jlr.D023739 publication March 2018 Analysis of Urinary Eicosanoids by LC-MS/MS Reveals Alterations in the Metabolic Profile after Smoking Cessation Goettel M, Niessner R, Scherer M, Scherer G, Pluym N Chemical Research in Toxicology, Volume 31, doi: 10.1021/acs.chemrestox publication October 2017 Metabolomic Fingerprinting in Various Body Fluids of a Diet-Controlled Clinical Smoking Cessation Study Using a Validated GC-TOF-MS Metabolomics Platform Goettel M, Niessner R, Mueller D, Scherer M, Scherer G, Pluym N Journal of Proteome Research, Volume 16(10), doi: 10.1021/acs.jproteome.7b00128. publication April 2018 Suitability of biomarkers of biological effects (BOBEs) for assessing the likelihood of reducing the tobacco related disease risk by new and innovative tobacco products: A literature review Scherer G Regulatory Toxicology and Pharmacology, Volume 94, doi: 10.1016/j.yrtph.2018.02.002
sICAM-1	Inflammation	Plasma	ELISA

Pioniere in der Biomarker-Forschung

Alle im ABF entwickelten Biomarker-Methoden wurden in Fachzeitschriften mit Peer-Review-Verfahren veröffentlicht. Eine Tatsache, die die Validität, Transparenz und wissenschaftliche Evidenz der Bioanalytik untermauert. Dies ist vor allem für Zulassungsanträge bei Regulatoren von Bedeutung.