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Biomarker Services

Support drug development decisions with comprehensive biomarker services from SGS – accurate measurement of biological response across small molecules, biologics and advanced therapies.

Understanding biological response is central to demonstrating mechanism of action, monitoring efficacy and generating regulatory-ready data across drug development. As programs advance through early research, clinical trials and commercialization, the demand for accurate, reproducible biomarker data grows in scope and complexity – particularly for biologics, advanced therapies and translational studies.

We provide comprehensive biomarker services that combine advanced analytical technologies with in-depth scientific expertise. Our integrated capabilities support small molecule, biologics and advanced therapy programs from early development through to commercial quality control, delivering data aligned with regulatory expectations.

Generate robust biomarker data across the development life cycle

  • Demonstrate mechanism of action

    Measure biological drug response, target engagement and pathway activity to support translational and clinical decision-making.

  • Support regulatory submissions

    Generate validated, reproducible biomarker data suitable for regulatory review across global markets.

  • Address complex therapeutic modalities

    Apply biomarker analysis to cell and gene therapy, mRNA and CAR-T programs, including detection of therapy-produced cells.

  • Integrate with broader bioanalysis

    Combine biomarker work with pharmacokinetic (PK), pharmacodynamic (PD), immunogenicity and cell-based bioassays through a single, integrated provider.

  • Access advanced analytical platforms

    Use flow cytometry, qPCR, ddPCR, LC-MS/MS and multiplex immunoassays to deliver high-quality data across diverse biomarker types.

  • Scale across the development life cycle

    Move from early research through clinical studies and into commercial quality control with consistent analytical support.

Discover our biomarker services

  • Cellular biomarker analysis

    We deliver immunophenotyping, including T-cell, B-cell and immune profiling, alongside cell activation and functional response assays, detection of therapy-produced cells such as CAR-T, and PBMC isolation and processing.

  • Soluble biomarker analysis

    We provide cytokine and chemokine profiling, protein biomarker measurement using ligand-binding assays and ELISA, multiplex biomarker panels and quantification of circulating biomarkers.

  • Molecular biomarker services

    We perform gene expression analysis, qPCR and nucleic acid quantification, mRNA analysis and knock-down studies, supported by biomarker assay development and validation.

  • PD biomarkers

    We measure biological drug response, conduct receptor occupancy assays, and support target engagement, pathway analysis and mechanism-of-action studies.

  • Integrated bioanalytical support

    We integrate biomarker services with our broader bioanalysis capabilities, including PK/PD bioanalysis, immunogenicity testing, cell-based bioassays and hybrid assays combining ligand-binding with LC-MS/MS.

  • Advanced technologies and platforms

    We use flow cytometry (FACS), qPCR, ddPCR and molecular techniques, LC-MS/MS and multiplex immunoassays to deliver accurate, high-quality biomarker data.

Why SGS?

As a world leader in pharmaceutical testing, inspection and certification, we combine advanced analytical platforms with in-depth scientific expertise to deliver biomarker services across diverse therapeutic modalities. Our integrated bioanalysis capabilities support small molecule, biologics and advanced therapy programs, with established experience in cell and gene therapy, mRNA and CAR-T applications.

Our global laboratory network and end-to-end analytical capabilities enable consistent support from early research through clinical studies and into commercial quality control, helping you maintain quality, compliance and data integrity across the development life cycle.

SGS Health Science Laboratory Berlin, Germany

FAQs

We deliver a comprehensive suite of biomarker services covering four core analysis areas: cellular biomarker analysis, soluble biomarker analysis, molecular biomarker services and pharmacodynamic biomarkers. These services support decision-making across drug development, with capabilities tailored to biologics, small molecules and advanced therapies.

Our biomarker work is integrated with our broader bioanalysis capabilities, including PK/PD bioanalysis, immunogenicity testing, cell-based bioassays and hybrid assays.

Our biomarker services support small molecule, biologics and advanced therapy programs. We have established experience supporting complex therapies, including:

  • Cell and gene therapy programs
  • mRNA programs
  • CAR-T programs

This includes detection of therapy-produced cells, supporting safety, efficacy and translational insights from early development through clinical studies.

We support biomarker work across the full development life cycle, from early research through clinical trials and into commercial quality control. Our integrated capabilities enable consistent analytical support as programs progress, helping you maintain data quality and continuity across stages.

We use advanced platforms to deliver accurate, high-quality biomarker data, including:

  • Flow cytometry (FACS)
  • qPCR, ddPCR and molecular techniques
  • LC-MS/MS
  • Multiplex immunoassays

These platforms support our cellular, soluble, molecular and pharmacodynamic biomarker capabilities.

We measure biological drug response through PD biomarker services, including receptor occupancy assays, target engagement studies and pathway analysis. These capabilities support mechanism-of-action work and translational decision-making throughout drug development.

Our cellular biomarker analysis includes immunophenotyping such as T-cell, B-cell and immune profiling, cell activation and functional response assays, detection of therapy-produced cells such as CAR-T, and PBMC isolation and processing.

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  • SGS - Sweden - Linkoping

Olaus Magnus väg 27,

583 30,

Linkoping,

Sweden