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Bioanalysis for Cell & Gene Therapies

Support cell and gene therapy development with end-to-end bioanalytical services from SGS – validated methods and regulatory-ready workflows for complex modalities, including mRNA, viral vectors and CAR-T.

Cell and gene therapy (CGT) programs introduce analytical challenges that go beyond traditional drug development. Modalities, such as mRNA, viral vectors and CAR-T, require specialized bioanalytical methods to characterize biological behavior, demonstrate potency, monitor functional response and confirm product quality across discovery, clinical work and commercial release.

We deliver end-to-end bioanalytical solutions for cell and gene therapy programs, combining advanced technologies, validated methods and regulatory-compliant laboratories. Our integrated capabilities support the full lifecycle of CGT products – from early characterization and method development through to clinical bioanalysis and final product release testing – maintaining consistency and compliance across stages.

Support cell and gene therapy programs with specialized bioanalytical capabilities

  • Address complex therapeutic modalities

    Apply specialized bioanalytical methods to mRNA, viral vector and CAR-T programs, including detection of therapy-produced cells and viral vector analysis.

  • Demonstrate potency and functional performance

    Use cell-based bioassays, receptor occupancy and immunophenotyping to characterize biological activity and target engagement.

  • Generate regulatory-ready data

    Apply validated methods and regulatory-compliant workflows to support critical quality attributes across CGT products.

  • Maintain continuity across the life cycle

    Move from early characterization and method development through to clinical bioanalysis and final product release testing through a single, integrated provider.

  • Access advanced analytical platforms

    Use flow cytometry, LC-MS/MS, qPCR and cell-based assay systems to deliver high-quality data for complex therapy programs.

  • Integrate bioanalysis across disciplines

    Combine pharmacokinetic (PK), pharmacodynamic (PD), biomarker, immunogenicity and bioassay work within a coordinated bioanalytical program.

Discover our cell and gene therapies bioanalysis services

  • Core bioanalytical capabilities

    We deliver a comprehensive suite of bioanalysis services to assess how therapies behave and perform in the body, spanning PK/PD, biomarker, immunogenicity and bioassay work.

  • Specialized cell and gene therapy bioanalysis

    We provide tailored solutions for advanced therapies, including molecular analysis, viral vector work and detection of therapy-produced cells such as CAR-T.

  • Bioassays and functional testing

    We support functional and potency assessment through immunophenotyping, including T-cell activation, target protein expression, receptor occupancy and measurement of cellular and soluble biomarkers.

  • Quality, safety and characterization

    We deliver services aligned with critical quality attributes across CGT products, including safety and contamination testing, identity and molecular characterization, potency and functional validation, and purity and batch consistency.

  • Advanced analytical technologies

    We use modern analytical platforms to support sensitive, reliable data generation, including flow cytometry (FACS), LC-MS/MS, qPCR and molecular assays, and cell-based assay systems.

Why SGS?

As a world leader in testing, inspection and certification, we provide specialized expertise in complex modalities including mRNA, viral vectors and CAR-T, combined with advanced technologies, validated methods and regulatory-compliant laboratories. Our integrated bioanalysis capabilities support coordinated work across PK/PD, biomarker, immunogenicity and bioassay disciplines, helping address the analytical complexity inherent to cell and gene therapy programs.

Our global laboratory network supports CGT developers across the full life cycle, from early research through to clinical studies and commercial release, helping you maintain quality, compliance and data integrity at every stage.

SGS Health Science Laboratory Berlin Germany

FAQs

Cell and gene therapy (CGT) bioanalysis covers the analytical work required to characterize, measure and confirm the behavior, performance and quality of advanced therapies. We deliver end-to-end bioanalytical solutions for CGT programs, supporting the full product life cycle from early characterization and method development through clinical bioanalysis to final product release testing.

This work spans PK/PD bioanalysis, biomarker analysis, immunogenicity testing, bioassays and product characterization, with methods tailored to the specific challenges of complex modalities.

Our services support advanced therapies including mRNA, viral vectors and CAR-T programs. We deliver specialized capabilities, such as PK bioanalysis for mRNA and CAR-T quantification, viral vector analysis and detection of therapy-produced cells.

We support the full lifecycle of cell and gene therapy products, from early research through clinical trials and into commercial release. Our integrated capabilities maintain consistency, compliance and continuity across:

  • Early characterization and method development
  • Clinical bioanalysis
  • Final product release testing

We deliver a comprehensive suite of bioanalysis services to support understanding of how therapies behave and perform in the body, including:

  • PK/PD bioanalysis
  • Biomarker analysis (cellular and soluble)
  • Immunogenicity testing
  • Cell-based bioassays (potency, receptor occupancy, immunophenotyping)
  • Hybrid assays (LBA + LC-MS/MS)

Our specialized CGT bioanalysis services include qPCR and molecular analysis, PK bioanalysis for mRNA and CAR-T quantification, PD bioanalysis covering gene expression and knock-down studies, viral vector analysis, detection of therapy-produced cells such as CAR-T, and PBMC isolation.

We support functional and potency assessment through bioassays including:

  • Immunophenotyping, such as T-cell activation
  • Target protein expression
  • Receptor occupancy
  • Cellular and soluble biomarkers

We use modern analytical platforms to deliver high-quality data for cell and gene therapy programs, including:

  • Flow cytometry (FACS)
  • LC-MS/MS
  • qPCR and molecular assays
  • Cell-based assay systems

Our services are designed to support critical quality attributes across CGT products, covering safety and contamination testing, identity and molecular characterization, potency and functional validation, and purity and batch consistency.

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  • SGS - Lithuania - Klaipeda

95112,

Klaipeda,

Lithuania