Bioanalytical Solutions for Pharma

Our comprehensive catalogue of bioanalytical services is tailored to meet the specific needs of your project, supporting pre-clinical and clinical trials. Backed by strict regulatory compliance, we offer integrated solutions to support our customers’ drug development journey from start to registration. With advanced analytical expertise and state-of-the-art equipment, we're your trusted partner in keeping pace with the latest trends in analytical chemistry.

ADME, DMPK & DDI Study Support

  • Comprehensive metabolite profiling
  • Quantitative bioanalysis for pharmacokinetic (PK), toxicokinetic (TK), pharmacodynamic (PD), drug-drug-interaction, and bioequivalence studies

Biomarker Identification & Analysis

  • Non-Targeted-Screening (NTS) with high-resolution LC-MS
  • Identification of metabolites and suitable biomarkers in plasma and other matrices
  • Method development and validation in compliance with ICH M10 Guidelines on Bioanalytical Method Validation and Sample Analysis
  • Transfer and cross-validation of proprietary methods

Physicochemical Characterization

  • Plasma stability studies
  • Identification of degradation product and drug impurities
  • Enantioselective separation of chiral substances

Targeted & Untargeted Metabolomics

  • Advanced non-targeted HR-MS workflows for metabolic profiling
  • Quantitative determination of fatty acid / amino acid metabolism, and inflammation and oxidative stress biomarkers
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metabolite
Bioanalytical Services for Small Molecules

Bioanalytical Services for Small Molecules

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Comprehensive Pharmacokinetic (PK), Toxicokinetic (TK) and Pharmacodynamic (PD) Studies

Comprehensive Pharmacokinetic (PK), Toxicokinetic (TK) and Pharmacodynamic (PD) Studies

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Metabolite Profiling, Identification and Structural Elucidation

Metabolite Profiling, Identification and Structural Elucidation

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Unlocking Insights with Biomarker Analysis

Unlocking Insights with Biomarker Analysis

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Do you have any questions about our services?

We would be happy to advise and support you with your project or your study. Send us your request and tell us your specific wishes.

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Our biomarker methods

Biomarker Exposure to Matrix Analytical Technique Reference
11-dehydro-TXB2InflammationUrineLC-MS/MS
2,3-dinor-8-iso-PGF2αOxidative StressUrineLC-MS/MS
2,3-dinor-TXB2InflammationUrineLC-MS/MS
8-iso-PGF2αOxidative StressUrineLC-MS/MS
Leukotriene E4InflammationUrineLC-MS/MS
Metabolomics (GC)—Urine, Plasma, Saliva, Exhaled BreathGC-TOF-MS
Metabolomics (LC)—Urine, Plasma, SalivaLC-Orbitrap-MS
PGF2αOxidative StressUrineLC-MS/MS
Prostaglandin DOxidative StressUrineLC-MS/MS
Prostaglandin EOxidative StressUrineLC-MS/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.

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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

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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

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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

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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

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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

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Conference contribution|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

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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

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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

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Pioneers in biomarker research

Almost all of the biomarker methods developed at ABF were published in peer-reviewed journals, a fact that supports the validity, transparency and scientific evidence of the bioanalysis especially of importance for regulatory submissions

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