Global Specialty Laboratory Services

Every breakthrough therapy demands analytical excellence under pressure.

Biomarker validation programs that must deliver consistent results across global trial sites. Complex assays validated to withstand regulatory scrutiny. Flow cytometry panels harmonized between hemispheres.

Scientific decisions that can’t wait for vendor delays.

Your most ambitious research deserves laboratory partners who understand these challenges.

At Cerba Research, we combine deep scientific expertise with cutting-edge technology to support your critical decisions from discovery through commercialization. 12 specialty laboratories across five continents, backed by a global central laboratory network, delivering customized solutions without compromising on scientific rigor.

Histopathology and IHC: Precision pathology for biomarker-driven trials

When tissue-based biomarkers drive clinical decisions.

Modern oncology and immunology trials demand expert pathology interpretation. From PD-L1 expression to multiplex tumor microenvironment analysis, histopathology and IHC provide the critical tissue-based insights that guide precision medicine. Our global network of board-certified pathologists and state-of-the-art platforms ensures consistent, reproducible results across your trial sites.

Core capabilities:
  • 250+ targets, protocols, and clones for clinical trials:
    • Simplex IHC: ~160 targets
    • Multiplex IHC: ~30 panels
    • Special stains: ~30 types
    • Performed across multiple platforms: Roche Ventana, Dako Omnis, and Akoya PhenoImager.
  • Digital pathology with AI-powered image analysis (Halo®, Visiopharm®, Inform®)
  • International network of board-certified pathologists for centralized review
  • Spatial biology solutions (NanoString® GeoMx, FISH, ISH/RNAScope)
  • Fit-for-purpose validation with 3-7 month timelines for regulatory submission and depending on validation level

From companion diagnostics to exploratory biomarkers, we provide the histopathology expertise that transforms tissue samples into actionable clinical insights.

Think global, act local

12 specialty laboratories across five continents with advanced technology platforms and therapeutic area expertise

Belgium (Ghent)

Routine, Molecular Biology,
Bioanalytical Lab, Flow
Cytometry, Microbiology

Industriepark-Zwijnaarde 3,
9052, Belgium

  • Office number: +32 94 96 80 28
  • Direct line: +32 94 96 82 19

France (Paris & Montpellier)

Genetics/NGS, Molecular Biology,
IVD, Flow Cytometry,
Histopathology/
IHC, Virology, Biorepository, BSL3

Paris:
Zac des Epineaux 10 Avenue Rolland Moreno CS 51312 95740, FREPILLON, France
Quality Charter

Montpellier:
126 Rue Emile Baudot,
34000, France

South Africa (Johannesburg)

Routine, Genetics/NGS, Molecular
Biology, Virology, Microbiology,
BSL3, Biorepository

China (Shanghai)

Routine, Genetics/NGS, Molecular Biology,
Flow Cytometry,
Bioanalytical Lab/PK,
Histopathology/IHC

Taiwan (Taipei)

Routine, Genetics/NGS, Flow
Cytometry, Histopathology/IHC Lab,

Sydney (Australia)

Routine, Molecular Biology,
Flow Cytometry, Virology

Tokyo (Japan)

Shinjuku I-Land-Tower 10F
6-5-1, Nishishinjuku, shinjuku-ku
163-1310, Japan

The Netherlands

BSL3, Pre-clinical, Molecular
Biology, Genetics/NGS,
Pathology, Virology

Rotterdam:
Rotterdam Science Tower
Marconistraat 16
3029 AK, The Netherlands

Rijswijk:
Visseringlaan 25
2288 ER, The Netherlands

Schaijk:
Nistelrooise Baan 3
5374 RE, The Netherlands

New York (North America)

10 Nevada Drive
Lake Success, NY 11042, USA

Routine, Genetics/NGS,
Molecular Biology, IVD, Flow
Cytometry, Bioanalytical Lab/PK,
Histopathology/IHC, Virology

Montreal (North America)

3150 Rue Delaunay
Laval, QC, Canada, H7L 5E1

Routine, Genetics/NGS,
Molecular Biology, IVD, Flow
Cytometry, Bioanalytical Lab/PK,
Histopathology/IHC, Virology

Cape Town

Birkdale building 2
Riverpark Business Park
Mowbray, South Africa

Durban

95 King Cetshwayo Highway
Block A, 2nd Floor Westridge
4001, South Africa

4 Key Regions

North America Europe Asia-Pacific Africa
New York, Montreal Paris, Ghent, Rotterdam, Montpellier Shanghai, Taipei, Sydney, Japan Johannesburg partnership
New York (histopathology/IHC, flow cytometry: Cytek Aurora, NGS), Montreal (bioanalytical: PK/ADA/immunogenicity, immunoassays) Paris/Frépillon (Complete platform: IHC/multiplex, flow cytometry, NGS, AAV testing, bioanalytical services), Ghent (bioanalytical, flow, immunoassays), Rotterdam (pre-clinical, pathology, BSL3), Montpellier (histopathology/IHC/Nanostring) Shanghai (flow, NGS, IHC, bioanalysis), Taipei (flow, NGS, IHC), Sydney (flow cytometry) Johannesburg partnership (BSL3, infectious disease, flow cytometry)

Therapeutic area excellence through scientific depth

Specialized expertise where complexity meets innovation

Oncology

210+ trials since 2018
75% with specialty testing
32 market authorizations in both solid and liquid tumors

 

 

Learn more

Infectious Diseases & Vaccines

400+ trials since 2018
75% with specialty testing
BSL3 network
27 market authorizations
Expertise in TB, HIV, RSV, COVID-19

 

Explore more

Cell & Gene Therapy

50+ trials since 2018
85% with specialty testing
CAR-T, TCR-T, CAR-NK, AAV, gene editing support
5 market authorizations including 3 CAR-T therapies

 

 

Discover more

Inflammation & Immunology

125+ trials since 2018
50% with specialty testing
Expertise in IBD, osteoarthritis, autoimmune diseases, atopic dermatitis

 

 

Find out more

Rare Diseases

230+ trials since 2018
Customized biomarker strategies
Gene therapy validation
44 market authorizations
Expertise in rare neoplasms, infectious or parasitic diseases, skin diseases

 

Uncover more insights

Metabolic & Neurology

Specialized testing
Biomarker discovery
Advanced genomics support

 

Explore Metabolic capabilities
Discover Neurology capabilities

State-of-the-art platforms for complex biomarker strategies
From sample to insight: comprehensive specialty testing capabilities

Histopathology & IHC

  • 50+ validated antibodies and protocols
  • Simplex and multiplex IHC (Roche Ventana Discovery Ultra, Dako Omnis, Akoya PhenoImager HT)
  • Board-certified pathologists with centralized review
  • Digital pathology with AI-powered image analysis (Halo®, Visiopharm®, Inform®)
  • Spatial biology solutions (NanoString® GeoMx, FISH, ISH/RNAScope)
  • Tissue biorepository services
  • 3-7 month fit-for-purpose validation timelines

Flow Cytometry

  • Conventional and spectral platforms (BD FACSLyric, Cytek Aurora 5-laser)
  • Validated panels for immune monitoring, CAR-T enumeration, MRD detection (for MM only)
  • Custom assay development with early scientific engagement
  • Intracellular cytokine staining (ICS)
  • Global harmonization across five flow cytometry hubs
  • 14-25 color immunophenotyping capabilities

Next Generation Sequencing & Genomics

  • Comprehensive oncopanels, broad panels and custom panels
  • Liquid biopsy (ctDNA, circulating tumor cells)
  • TCR/BCR sequencing
  • RNA-seq
  • Whole exome/whole genome sequencing
  • HLA typing
  • Optical genome mapping (next-generation cytogenetics)
  • Vector copy number analysis
  • NanoString® spatial genomics

Immunoassays & AAV Testing

  • IVDR-compliant anti-AAV antibody assays for gene therapy programs
  • Large amount of validated ligand-binding assays
  • Cytokine profiling (37-plex for CRS monitoring)
  • Soluble protein analysis (BCMA, biomarkers)
  • MSD, ELLA, ELISA, ELISpot platforms
  • GLP and non-GLP studies for pre-clinical and clinical programs

Bioanalytical Services: PK/Immunogenicity/ADA

  • Full PK/ADA/NAb programs for biologics, biosimilars, and cell & gene therapies
  • Pre-clinical (GLP & non-GLP) and clinical (primary, secondary, exploratory endpoints)
  • Method development and validation aligned with regulatory guidelines
  • Immunogenicity testing with T and B cell assays
  • LC-MS and ligand-binding platforms
  • Vector biodistribution studies

Virology & BSL3 BSL3

  • Laboratory network for infectious disease and vaccine research
  • Viral load quantification (PCR, ddPCR)
  • Serology and immunogenicity
  • RCL/RCR testing for gene therapy safety
  • Method transfer to remote regions
  • High-throughput capabilities

Cell and gene therapy: Your complete analytical partner

Every cell therapy program faces endless analytical challenges.

How do you monitor CAR-T persistence across diverse patient populations? How do you validate vector copy number with regulatory confidence? How do you harmonize complex flow cytometry panels across global sites? How do you ensure anti-AAV antibodies don’t compromise gene therapy efficacy?

Cell and gene therapies demand specialized laboratory expertise at every development stage. Our comprehensive guide reveals the analytical strategies that have supported 50+ CGT trials and 5 market authorizations, including 3 CAR-T therapies.

What you’ll discover in our guide:

  • The critical assays for CAR-T monitoring: flow cytometry enumeration, persistence, and phenotyping
  • Strategies for vector copy number, integration site analysis, and biodistribution
  • IVDR-compliant anti-AAV antibody testing for patient selection and monitoring
  • IHC and spatial biology approaches for tumor microenvironment analysis in solid tumor CGT
Download the Cell & Gene Therapy Testing Guide

Europe's largest specialty laboratory

Purpose-built excellence in Frépillon, Paris

This flagship facility represents the pinnacle of specialty laboratory technology. Opened in 2024, this 23,000 square meter laboratory houses the most comprehensive array of advanced testing platforms in Europe, combining cutting-edge instrumentation with deep scientific expertise.

Key capabilities:

  • Unmatched specialty test menu: 2,000+ tests spanning histopathology,
    genetics / genomics, flow cytometry, and bioanalysis
  • State-of-the-art platforms: Roche Ventana Discovery Ultra, Cytek Aurora spectral flow, Illumina NovaSeq, Akoya PhenoImager
  • Scientific depth: 30+ specialized clinical pathologists and 50,000 specimens per day from 50 countries 

 

  • BSL3 containment facilities for infectious disease and vaccine research
  • Backed by high-volume infrastructure processing 50,000+ specimens daily.
  • ISO15189 certified since 2005, CAP accreditation by Q1 2026

Why Cerba Research for specialty laboratory services?

Scientific leadership through early engagement

Our specialist scientists work with you from protocol design to optimize biomarker strategies, develop fit-for-purpose assays, and leverage proven methodologies from hundreds of successful trials. From histopathology validation to complex flow panels, early scientific consultation ensures your testing strategy aligns with regulatory expectations.

Seamless specialty and central lab integration

When your trial demands both advanced biomarker testing and routine safety monitoring, our integrated platform eliminates coordination headaches. One partner, one quality system, seamless data flow. Our global central laboratory network provides comprehensive routine testing alongside specialty capabilities.

Global scale with therapeutic focus

Fourteen specialty laboratories backed by deep expertise in oncology, infectious diseases, cell & gene therapy, and immunology. Harmonized SOPs and centralized scientific oversight ensure consistent excellence across continents. Our technology breadth—from IHC to NGS to AAV testing—means you never compromise on capability.

The accreditations and regulatory experience you expect

CAP

ISO15189

FDA

EMA

CLIA

GLP

IVDR

Our accreditations span continents and therapeutic areas, ensuring your specialty testing meets the highest international standards for regulatory submission across global markets.

Ready to advance your biomarker strategy?

Whether you’re developing a companion diagnostic requiring validated IHC protocols, a CAR-T therapy demanding complex flow cytometry panels, a biologic needing comprehensive immunogenicity testing, or a gene therapy requiring AAV antibody screening, our specialty laboratory services provide the scientific expertise and global infrastructure you need.