Bioanalytical Services
Cellular assay services for immunology and pharmacodynamic studies
Crux Biolabs provides pharmacodynamic (PD) cellular assay services to support clinical development programs. Our cell-based assay capabilities help characterise treatment-related immune and cellular responses, generating reliable data to inform clinical development and therapeutic evaluation.
Cellular insights for confident clinical development decisions
Understanding how treatment affects cellular responses is central to evaluating pharmacodynamic activity and therapeutic effect. Crux Biolabs designs and performs fit-for-purpose cellular assays that assess immune-cell populations, activation states, receptor engagement and functional responses.
Our end-to-end service includes PBMC isolation, processing, cryopreservation, storage and downstream analysis. We work closely with sponsors to align assay strategies, sample handling and data outputs with the objectives of each clinical study, including immuno-oncology and cell-therapy programs.
Our cellular assay capabilities
PBMC processing and biobanking
We provide robust PBMC isolation, processing, cryopreservation and storage to protect sample integrity and enable reliable downstream analysis. Our team applies established processing approaches, including Ficoll® density-gradient centrifugation, SepMate™ and CPT™ tubes, supported by electronic sample tracking for end-to-end traceability.
Dedicated cellular laboratory suite
Our dedicated cellular laboratory suite supports controlled handling, processing, cryopreservation, storage and analysis of cellular samples. Defined procedures, trained personnel and electronic sample tracking support sample integrity and end-to-end traceability across the cellular bioanalysis workflow.
High-parameter spectral flow cytometry
Our Cytek Aurora spectral flow cytometry platform supports up to 40-colour analysis. Applications include activation assays, intracellular marker and cytokine analysis, phospho-flow and CAR-T cell characterisation.
In-vitro functional cellular assays
We perform proliferation, viability, inhibition, stimulation and cytotoxicity assays using primary cells and cell lines. Our capabilities also include cytokine release assays and cell-mediated immunity assays to assess treatment-related functional immune responses. These assays can be integrated with flow cytometry and complementary biomarker analyses to provide a clearer view of cellular function and treatment response.
Why partner with Crux Biolabs for cellular assays
Crux Biolabs combines specialist immunology expertise with fit-for-purpose cellular bioanalysis delivered through controlled processes. We work closely with sponsors to develop, optimise and deliver assay approaches aligned to the therapeutic mechanism, study design and intended data use.
Our services are supported by NATA-accredited processes and participation in the Immunovirology Research Network Quality Assurance Program. Together with robust sample management and experienced scientific oversight, this provides confidence in the quality, traceability and consistency of your cellular assay data.
Quality and compliance
Crux Biolabs’ cellular assay services are delivered within a quality framework aligned with applicable regulatory expectations for clinical bioanalysis. We apply fit-for-purpose assay development, optimisation, qualification and validation approaches based on each assay’s intended use, the cellular matrix and the requirements of the study.
Crux Biolabs operates an ISO/IEC 17025-accredited, GCLP-compliant quality management system. Controlled processes, documented procedures and data-review practices support reliable, traceable and scientifically defensible results for clinical research.
