Β© 2026 CellCarta - All rights reserved.
When you run a biomarker program in Europe, you're managing a complex system: whether youβre a local pilot or connected to trial sites spanning the EU countries, or the globe, every sample matters. Add time changes between teams in North America and APAC, plus IVDR requirements, and logistics can get complicated.
CellCarta built its EU presence to make immune monitoring more simple. Our lab in Belgium runs on the same protocols, platforms, and quality standards as those across our global network. Plus, CellCarta can provide EU critical biomarker testing using in-house IVDs under Article 5(5) of the IVDR, which may help accelerate the transition from assay development and validation to clinical sample testing, when study conditions are met.
Quality isn't a checkpoint, it's how we work. We can support your immunology programs across all phases of development, from first-in-human through pivotal clinical programs, with a local European flow cytometry centre and the scientific depth and operational discipline to protect your data at every step.
β Science-led biomarker selection and assay development
βGlobally harmonized laboratories, including our Gosselies, Belgium flow cytometry centre.
β Able to provide in-house IVDs when study conditions are met
β All phases of clinical development supported
β Regulatory-ready data for the EMA, FDA, and beyond
Immune monitoring decisions shape the trajectory of your clinical program. Extended shipping timelines, misaligned biomarkers, insufficient assay sensitivity, or cross-site variability can delay timelines and compromise confidence in your data, especially when a program spans Europe alongside other regions.
25 years of clinical biomarker and therapeutic knowledge that allows us to anticipate and reduce risk
Dedicated Project Manager and Scientists for each project, working as an extension of your team
Trusted by top 10 emerging biotech start-ups and & 20/20 leading large pharma companies
Worldwide footprint: our immunology labs are in North America, Europe, China, Australia
Handling all assays: from complex to routine
With an immunology team based in Belgium and connected to CellCarta's global lab network, the right biomarker strategy does more than generate data. It builds the kind of confidence that holds up in every submission, across every region, through every phase.
Quality starts with people. Our Belgium-based team of PhD-level scientists brings deep, hands-on expertise in flow cytometry and immunology, actively contributing to the scientific community through participation in worldwide conferences. By staying closely connected to the latest advancements, we ensure our approaches remain at the forefront of innovation while grounded in proven methodologies .
Built for reliability. Our multi-site infrastructure, including our Belgium laboratory, provides true operational resilience. With established assay transfer capabilities and seamless cross-lab coordination, we maintain continuity even in the face of shifting timelines or unexpected disruptions. This means fewer delays, stronger data integrity, and a partner you can depend on to keep your studies on track.
Quality starts with people. Our team of PhD-level scientists brings deep, hands-on expertise in flow cytometry and immunology, actively contributing to the scientific community through participation in worldwide conferences. By staying closely connected to the latest advancements, we ensure our approaches remain at the forefront of innovation while grounded in proven methodologies .
Immune monitoring decisions shape the trajectory of your clinical program. Misaligned biomarkers, insufficient assay sensitivity, or cross-site variability can delay timelines and compromise confidence in your data.
Quality matters at every stage. With a specialist immunology CRO, the right biomarker strategy does more than generate data. It builds the kind of confidence that holds up in every submission, across every region, through every phase.
Across therapeutics and modalities, flow cytometry can provide key insights. From CAR-T detection and enumeration to TBNK and TBNK+CD20 panels to receptor occupancy assays and more, our Off-The-Shelf and custom panels help advance studies with high quality data.
Across therapeutics and modalities, flow cytometry can provide key insights. From CAR-T detection and enumeration to TBNK and TBNK+CD20 panels to receptor occupancy assays and more, our Off-The-Shelf and custom panels help advance studies with high quality data.
Local isolation and storage of PBMCs allows reduced time in shipping. Isolated PBMCs, including the plasma and cellular components can be used for further downstream application such as flow cytometry, mass spectrometry, MSD and ELISpot.
Following recent updates to the FAMHP Q&A on in-house IVDs, CellCarta can provide EU testing using in-house IVDs under Article 5(5) of the IVDR, which may help accelerate the transition from assay development and validation to clinical sample testing when study conditions are met.
Our Belgium-based immunology team works within the same harmonized quality systems as our labs in North America, Australia, and China, so sponsors running programs in the region get local scientific depth without sacrificing global consistency.
Local isolation and storage of PBMCs allows reduced time in shipping. Isolated PBMCs can be used for further downstream application such as flow cytometry, mass spectrometry, and ELISpot.
Following recent updates to the FAMHP Q&A on in-house IVDs, CellCarta can provide EU testing using in-house IVDs under Article 5(5) of the IVDR, which may help accelerate the transition from assay development and validation to clinical sample testing when study conditions are met.
Our Belgium-based immunology team works within the same harmonized quality systems as our labs in North America, Australia, and China, so sponsors running programs in the region get local scientific depth without sacrificing global consistency.
25 years of clinical biomarker and therapeutic knowledge that allows us to anticipate and reduce risk
Dedicated Project Manager and Scientists for each project, working as an extension of your team
Trusted by top 10 emerging biotech start-ups and & 20/20 leading large pharma companies
Worldwide footprint: our immunology labs are in North America, Europe, China, Australia
Handling all assays: from complex to routine
Handling all assays: from complex to routine