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
Bioanalytical Solutions for Pharma
Human Biomonitoring: Advancing Public Health through Exposure Assessment
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Bioanalytical Services for Small Molecules
Bioanalytical Services for Small Molecules
At ABF, we specialize in the precise quantification of drugs, narcotics, metabolites, and endogenous compounds in various biological matrices. Our dedicated bioanalytical department comprises an experienced team of scientists and technicians with decades of experience in bioanalysis.
Our state-of-the-art laboratory is equipped with six triple quadrupole LC-MS/MS instruments, ensuring high sample throughput, sensitivity, and selectivity.
Our comprehensive services include:
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- Analytical method development and validation in full compliance with ICH M10 guidelines
- Method transfer and cross-validation of sponsor-supplied methods
- Non-proprietary assays to support bioequivalence, drug-drug interaction, and various other study types across all phases of drug development
- Quantitative sample analysis in human and animal matrices, including blood, plasma, serum, urine, saliva, feces, and tissues
- Bioanalytical reports compliant with GLP and GCP standards for global regulatory submissions
- Stability testing in plasma and other matrices (serum, urine, saliva etc).
Comprehensive Pharmacokinetic (PK), Toxicokinetic (TK) and Pharmacodynamic (PD) Studies
Comprehensive Pharmacokinetic (PK), Toxicokinetic (TK) and Pharmacodynamic (PD) Studies
Understanding the fundamentels of pharmacokinetics (PK), pharmacodynamics (PD), and toxicokinetics (TK) is of utmost importance in drug development. At ABF, we boast a wealth of experience in this field, offering ultra-sensitive, cost-efficient, and high-throughput analytical methods adhering to ICH M10 guidelines and GLP/GCP principles.
Our validated, ultrasensitive LC-MS/MS methods have supported multiple regulatory submissions to the U.S. Food and Drug Administration (FDA), establishing ABF as a trusted partner in PK, PD and TK analysis.
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Metabolite Profiling, Identification and Structural Elucidation
Metabolite Profiling, Identification and Structural Elucidation
ABF is a reliable partner to support your drug development program. We provide full services in chemical structure elucidation, metabolite profiling, impurity identification, and degradation product analysis. Our non-targeted screening (NTS) platform utilizes high-resolution Orbitrap-MS analysis for metabolite identification. Identified substances can then be further analyzed through the development of targeted, validated LC-MS/MS methods, ensuring accurate and sensitive quantification. With deep expertise in metabolite profiling and impurity identification, ABF is your trusted partner for preclinical and clinical trials, ensuring compliance with all regulatory requirements.
From in vitro metabolite identification to human ADME studies, our highly experienced scientists offer direct support. We partner closely with our clients to provide valuable insight, detailed explanations, and cost-effective solutions.
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Unlocking Insights with Biomarker Analysis
Unlocking Insights with Biomarker Analysis
Unlock valuable insights into drug safety and efficacy with biomarkers. ABF provides a diverse range of innovative technology platforms to help you select the perfect solutions for your requirements. We offer comprehensive, end-to-end bioanalytical services by integrating non-targeted screening with the development of validated LC-MS/MS methods to ensure the accurate and sensitive quantification of drug metabolites in plasma. With more than forty years of experience in biomarker research, we have accumulated a wealth of knowledge in the analysis of various matrices, including serum, plasma, urine, saliva, sputum and tissue. Our research has been published in peer-reviewed journals, demonstrating our dedication to enhancing the field. We comply with all international regulatory guidelines to guarantee exceptional standards in 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.
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
Frequently searched biomarkers