Cell Therapy Biomarker and Bioanalytical Solutions
Specialist cell therapy bioanalysis services supporting translational and clinical development.
Harness Synexa's Expertise to Advance Your Cell Therapy Development
Synexa Life Sciences offers a comprehensive range of biomarker and bioanalytical solutions to de-risk and accelerate the development of next-generation cell therapies. Our services provide integrated insights into therapeutic performance from initial discovery through to clinical persistence monitoring. By integrating cellular and genomic insights, we enable developers to navigate the unique complexities of “living drugs” and their functional interactions within the human disease environment.
Utilising advanced techniques such as high-parameter flow cytometry (validated to CLSI H62 standards), GCLP-accredited genomics (dPCR and qPCR), and single-cell functional analysis, we provide a detailed view of cell phenotype, potency, and safety. Our approach focuses on generating high-resolution data on therapeutic longevity and immune activation, providing the critical insights needed to predict clinical success.
Explore our End‑to‑End Cell Therapy Bioanalysis Solutions
Translational Science
Reduce clinical trial risk by validating therapeutic biology in human disease models. We generate mechanistic data from fresh patient samples to predict clinical response, inform biomarker strategy, and strengthen regulatory submissions ahead of clinical entry. We specialise in oncology and autoimmune conditions which are highly heterogeneous and require multi-pronged analytical approaches.
Immune Monitoring
Our GCLP-compliant ELISpot and FluoroSpot assays detect low frequency T cell and B cell responses critical for CAR-T assessment and immunotherapy monitoring.
Flow Cytometry
Gain reproducible cellular insights with custom high-parameter flow cytometry panels validated to CLSI H62 standards:
- Rare Cell Immunophenotyping: Identify and track specific cell subsets
- Target Engagement: Measure how effectively your cell therapy interacts with its intended target
- Immune Function: Validated assays to guide development decisions and assess cell potency
Proteomics and Soluble Biomarkers
Understand the mechanism of action and pathway modulation through advanced protein analysis.
- Olink Proteomics: Analyse up to 92 proteins from just 1 µL of sample, ideal for mechanism of action and patient stratification studies.
- Custom Panels: Measure disease activity and pathway modulation using MSD, LC-MS/MS, and ELISA platforms to drive decisions from Phase I through to approval
GCLP Accredited Genomics
Precision bioanalysis is critical for tracking cell therapy performance. Our genomics services include:
- Persistence: Monitoring the longevity of modified cells using sensitive qPCR and dPCR.
- Viral Shedding Studies: Essential for safety and regulatory compliance when using viral vectors.
- Advanced Detection: Targeted sequencing and circulating cell free DNA (ccfDNA) quantification across diverse sample matrices
Immunogenicity Assessment
Mitigate clinical risk by comprehensively evaluating unwanted immune responses to synthetic constructs and delivery vehicles.
- Therapeutic Component Profiling: Evaluate humoral and cellular immune responses to synthetic or non-human elements.
- Delivery System Monitoring: Identify and quantify anti-drug antibodies (ADAs) and anti-vector responses that may compromise the efficacy of viral vectors, providing critical data for the design of safe and effective repeat dosing regimens.
Improving the quality of human health
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Discuss biomarker and bioanalytical solutions to accelerate your therapeutic pipeline
