Biomarker Analysis

Comprehensive validated biomarker analysis services across all therapeutic areas and stages of drug development.

Biomarkers have become indispensable tools in modern drug development, providing objective and quantitative measures of biological processes, pharmacological responses, and disease states that support critical clinical and regulatory decision-making. The analytical quality of biomarker data is fundamental to ensuring their scientific validity and regulatory acceptance.

AMSbiopharma offers a comprehensive portfolio of biomarker analysis services, covering disease, safety, pharmacodynamic, and response biomarkers across multiple therapeutic areas. Our team combines extensive bioanalytical expertise with in-depth knowledge of biomarker development and strategy to support programmes from early research through clinical development.

All analytical methods are developed and validated according to fit-for-purpose principles, ranging from exploratory assays to fully validated methods suitable for regulatory submissions.

Our catalog of services include

Metabolomics applications

Inflammatory Biomarker Analysis

Inflammatory biomarkers are among the most widely evaluated endpoints in pharmaceutical development, providing critical mechanistic, pharmacodynamic, and safety data across immunology, oncology, autoimmune, metabolic, and central nervous system (CNS) diseases.

AMSbiopharma offers both targeted quantification of specific inflammatory biomarkers and broad inflammatory profiling approaches. Targeted assays provide the precision and validation status required for regulatory-grade pharmacodynamic data, while broad-panel approaches enable comprehensive inflammatory profiling to support biomarker discovery programmes.

Key analytical capabilities

  • Targeted quantification of individual cytokines, chemokines, and acute-phase proteins 
  • Broad-panel inflammatory profiling for biomarker discovery 
  • Development and validation of analytical methods for plasma, serum, and tissue matrices 
  • Applicable to immunology, oncology, autoimmune diseases, and metabolic disorders

Vascular and angiogenesis biomarkers play a central role in oncology, cardiovascular diseases, and ophthalmology. Key mediators such as vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and angiopoietins are widely used as pharmacodynamic endpoints in anti-angiogenic therapy programmes.

AMSbiopharma provides validated analytical services for the quantification of vascular proteins and angiogenic mediators in biological matrices, supporting mechanistic studies, target engagement assessment, and pharmacodynamic evaluations throughout drug development.

Key analytical capabilities

  • Quantification of VEGF, PDGF, angiopoietins, and related vascular biomarkers 
  • Method development and validation for plasma, serum, tissue, and other biological matrices 
  • Analytical support for pharmacodynamic monitoring in anti-angiogenic therapy programmes 
  • Applicable to oncology, cardiovascular diseases, and ophthalmology

Systemic disease biomarkers provide essential diagnostic, prognostic, and pharmacodynamic insights across a broad range of therapeutic areas.

AMSbiopharma provides validated analytical services for the quantification of proteins, enzymes, metabolites, and other disease-associated molecular targets in biological samples. Our methods generate high-quality data suitable for regulatory biomarker submissions and support companion diagnostic (CDx) development programmes.

Key analytical capabilities

  • Quantification of disease-associated proteins, enzymes, and metabolites 
  • Applicable across multiple therapeutic areas and disease indications 
  • Development and validation of analytical methods for pharmacodynamic monitoring in clinical trials 
  • Data packages aligned with FDA and EMA biomarker guidance

Oncology biomarkers are central to the design of modern clinical trials, enabling patient stratification based on predictive biomarker status, pharmacodynamic monitoring of target engagement, and the development of companion diagnostics (CDx).

AMSbiopharma provides bioanalytical services for the quantification of tumour-associated proteins, circulating biomarkers, pharmacodynamic endpoints, and response biomarkers in plasma, serum, tumour tissue, and liquid biopsy samples.

Key analytical capabilities

  • Quantification of circulating tumour biomarkers and pharmacodynamic endpoints 
  • Validated analytical methods for plasma, serum, tumour tissue, and liquid biopsy samples 
  • Analysis of patient stratification biomarkers for oncology clinical trials 
  • Applicable to immuno-oncology, targeted therapies, and antibody-drug conjugate (ADC) development programmes

Biomarkers have become indispensable tools in modern drug development, providing objective and quantitative measures of biological processes, pharmacological responses, and disease states that support critical clinical and regulatory decision-making. The analytical quality of biomarker data is fundamental to ensuring their scientific validity and regulatory acceptance.

AMSbiopharma offers a comprehensive portfolio of biomarker analysis services, covering disease, safety, pharmacodynamic, and response biomarkers across multiple therapeutic areas. Our team combines extensive bioanalytical expertise with in-depth knowledge of biomarker development and strategy to support programmes from early research through clinical development.

All analytical methods are developed and validated according to fit-for-purpose principles, ranging from exploratory assays to fully validated methods suitable for regulatory submissions.

Ceramides and sphingosines are bioactive lipid species with growing importance as biomarkers for cardiovascular risk stratification, metabolic diseases, and oncology.

AMSbiopharma provides validated LC-MS/MS analytical services for the targeted quantification of individual ceramide and sphingosine species in plasma, serum, and other biological matrices, delivering the specificity and sensitivity required for biomarker qualification and translational research.

Key analytical capabilities

  • Targeted quantification of individual ceramide and sphingosine species 
  • Development and validation of highly sensitive and selective LC-MS/MS methods 
  • Data quality aligned with applicable regulatory guidelines

Cortisol is a key biomarker in endocrinology, stress physiology, and hypothalamic–pituitary–adrenal (HPA) axis function, with broad applications in CNS, metabolic disease, oncology, and endocrine drug development.

AMSbiopharma provides validated analytical services for the quantification of cortisol in plasma, serum, urine, and saliva, using validated chromatographic methods with the sensitivity and specificity required to support both preclinical and clinical development programmes.

Key analytical capabilities

  • Quantification of cortisol in plasma, serum, urine, and saliva 
  • Development and validation of analytical methods with the sensitivity required for circadian rhythm monitoring 
  • Applicable to CNS, endocrinology, and metabolic disease programmes

Sphingolipids are bioactive lipid molecules with well-established roles in membrane structure, cell signalling, and inflammatory responses. The sphingolipidome has emerged as an important source of biomarkers for metabolic, neurological, and inflammatory diseases, as well as oncology.

AMSbiopharma provides LC-MS/MS-based analytical services for the targeted quantification and profiling of sphingolipid species in biological matrices, delivering the analytical selectivity required to accurately differentiate and quantify individual molecular species.

Key analytical capabilities

  • Targeted quantification and profiling of sphingolipid species using LC-MS/MS 
  • Applicable to metabolic, neurological, and inflammatory diseases 
  • Development and validation of analytical methods for clinical biomarker studies 
  • Data quality and reproducibility aligned with regulatory expectations