Bioanalytical Services
Spectral flow cytometry for PK and PD studies
Crux Biolabs provides spectral flow cytometry services for clinical research programs. Our experienced scientists design fit-for-purpose assays that generate robust cellular data for pharmacokinetic, pharmacodynamic and immunological endpoints.
Flexible flow cytometry solutions
for clinical development
Our spectral flow cytometry capability supports complex clinical research programs, generating robust cellular data to help sponsors understand therapeutic activity, immune responses and biological mechanisms.
Our capabilities support pharmacokinetic (PK) and pharmacodynamic (PD) assessments, including receptor-occupancy and target-engagement assays, immune-cell phenotyping, cell-mediated immunity assessment, vaccine-response evaluation, biomarker analysis and custom panel development.
For applicable modalities, including cell and gene therapies, flow-cytometry-based assays can support cellular PK assessment alongside PD, target-engagement and receptor-occupancy endpoints.
Using Cytek Aurora 5-laser spectral flow cytometry platforms, we can measure up to 40 parameters in a single run. This capability supports detailed cellular characterisation, including complex immune profiling, rare-cell analysis and assessment of therapeutic effects.
We develop fit-for-purpose panels aligned with each study’s objectives, sample type and required endpoints, enabling flexible study design and reliable, reproducible data generation.
Applications in clinical research
Crux Biolabs supports spectral flow cytometry studies across a range of clinical research applications, including:
Receptor occupancy and target engagement
Assessing therapeutic interaction with cellular targets
Immune-cell phenotyping
Characterising immune-cell populations and changes over time
Cell-mediated immunity and vaccine response
Evaluating cellular immune responses to vaccines and immunotherapies
Custom panels for complex studies
Developing fit-for-purpose panels for the study population, sample type and required endpoints
Biomarker and pharmacodynamic assessment
Monitoring cellular markers associated with biological activity and therapeutic response
Quality and compliance
Crux Biolabs’ flow cytometry services are delivered within a quality framework aligned with applicable regulatory expectations for clinical research.
Our spectral flow cytometry methods are developed, qualified and validated using fit-for-purpose approaches informed by applicable CLSI H62 guidance. This includes appropriate assessment of assay performance characteristics such as precision, accuracy, specificity, stability and robustness, based on the intended use of the method.
Crux Biolabs operates an ISO/IEC 17025-accredited, GCLP-compliant quality management system. Our controlled processes, documented procedures and data-review practices support reliable, traceable and scientifically defensible data for clinical research.
Why choose spectral flow cytometry?
Spectral flow cytometry enables simultaneous assessment of multiple markers in a single assay, supporting high-dimensional cellular analysis. It helps characterise complex cell populations and therapeutic effects while enabling more efficient panel design for challenging clinical-study samples.
This makes spectral flow cytometry particularly valuable for complex immune profiling, rare-cell analysis, biomarker assessment, receptor occupancy studies and vaccine-response evaluation.
Crux Biolabs works closely with sponsors to select markers and design assay panels aligned with each study’s scientific objectives and required endpoints.
Start local. Go global.
Through Crux Biolabs’ alliance with KCAS Bio, sponsors can access harmonised spectral flow cytometry support across participating laboratories in Australia, the United States and Europe.
Our Melbourne-based team provides direct scientific and project support, backed by aligned platforms, processes and quality oversight designed to support multi-region clinical programs.
Accelerate your program with established flow cytometry panels
Crux Biolabs offers selected established flow cytometry panels that can provide an efficient starting point for suitable clinical research applications.
| Assay kit | Platform | Sample matrix | Biomarkers measured |
|---|---|---|---|
| BD Multitest™ 6-color TBNK | Flow Cytometry | Whole blood collected in Cyto-Chex or sodium-heparin (NaHep) tubes | CD3, CD16/CD56, CD45, CD4, CD8 and CD19 |
| Cytek® cFluor® Human Pan Leukocyte Kit, LNW | Flow Cytometry | Whole blood collected in sodium-heparin (NaHep) tubes | CD45, CD3, CD4, CD8, CD14, CD16, CD19, CD20, CD56, CD66b, CD34, CD123, CD193 (CCR3), CD7, and HLA-DR |
If an established panel is not suitable for your required sample matrix, analytes or intended use, we can define a fit-for-purpose alternative or develop a customised flow cytometry panel.
