Driving Cell and Gene Therapy Success, from Translational Insight to Clinical Impact

We offer custom and off-the-shelf molecular (qPCR/ddPCR), flow cytometry, potency, and immunogenicity assays, including vector quantification, CAR expression, activation markers, anti-AAV screening/monitoring, neutralizing antibodies (Nabs), functional potency, and persistence.

We deliver end-to-end sample management with 24/7 support across five continents, including specialized handling for PBMCs, whole blood, bone marrow, and cryopreserved specimens.

We have deep, modality‑specific expertise across the full spectrum of cell and gene therapies. We support a wide range of cell therapy modalities, including autologous and allogeneic CAR‑T therapies, TCR‑T, NK cell therapies, TILs, and other engineered immune cell products.

In addition, we bring extensive experience in gene therapy modalities, notably AAV‑ and lentiviral‑based programs, as well as non‑viral delivery systems and mRNA‑based therapies.

We also support genome editing platforms, including CRISPR‑based approaches, through comprehensive molecular assays, sequencing, vector safety testing, and immunogenicity assessment.

Across all modalities, our services are delivered through harmonized CAP/CLIA and ISO15189‑accredited laboratories worldwide, ensuring consistent, high‑quality analytical, molecular, immunogenicity, and sequencing data.

CAR-T and cell therapy biomarker testing typically covers CAR transgene detection and vector copy number (by qPCR or ddPCR), CAR-T cell enumeration and persistence by flow cytometry, immunophenotyping of activation and exhaustion markers, cytokine profiling for cytokine release syndrome (CRS) monitoring (often 37-plex MSD panels), receptor occupancy assays, and immune repertoire sequencing for TCR/BCR diversity. Pharmacodynamic biomarkers vary by therapy and disease, but the core analytical package combines flow cytometry, molecular biology, and immunoassays delivered through a coordinated global workflow.

Global CGT trials demand strict harmonization because variability between sites can compromise the interpretation of persistence, biodistribution, or immunogenicity data. Consistency is achieved through replicated instrumentation across regions (e.g., matched Cytek Aurora or ddPCR platforms in every hub), standardized SOPs and panel designs, cross-site quality control programs, centralized data review by specialist scientists, and proven method transfer protocols. Cerba Research operates harmonized CGT analytical hubs across the United States, Belgium, the Netherlands, China, Taiwan, and Australia under unified quality management.

Specialty laboratories support CGT analytical testing from preclinical and translational research, through method development and validation, into first-in-human and pivotal trial execution, and onto post-approval monitoring. Each stage requires a different analytical approach: discovery and translational work needs flexible, fit-for-purpose assays; clinical phases require validated, regulatory-aligned methods with harmonized workflows across sites; post-approval studies need long-term immunogenicity and persistence monitoring. Cerba Research delivers this lifecycle support across CAP/CLIA and ISO 15189-accredited labs with IVDR-compliant options for late-phase programs.

We efficiently transfer sponsor-developed assays into our harmonized global network through standardized platforms, dedicated tech-transfer teams, proven inter-site method transfer, and the ability to optimize or adapt assays when needed. 

We routinely perform assay adaptation and transfer from sponsors, whether the assay is in a development stage or fully validated. Efficient transfer is supported by harmonized instrumentation, SOPs, and centralized data review across our global laboratories.