SERVICE BROCHURE
Cytek® Design-In Services
Cytek Design-In Services offers expertise in panel design, development, and validation to empower pharmaceutical companies and their CRO partners with innovative flow cytometry solutions. Whether there is a need to enable bio-marker discovery, further translational science discovery, or assist an analytical development team, Cytek Design-In Services will condense the time it takes to implement next-generation spectral flow cytometry panels and drive acceleration of your therapeutic programs.
Panel Design
Crafting an effective full spectral flow cytometry panel requires careful consideration of fluorochrome properties, clone selection, antigen density, marker co-expression, fluorochrome spillover, analytical strategies, and intended use. Our panel design services include:
- Panel specific literature review: We collaborate with you to identify key cellular markers tailored to your research question
- Panel method feasibility assessment: Before commencing panel design, we will assess the feasibility of the requested assay format and sample type
Panel Optimization
Once the panel design is finalized, panel development begins:
- Antibody titration: We optimize antibody concentrations to achieve the best signal-to-noise ratio
- Unmixing control optimization: Development includes establishing fluorescence-minus-one (FMO) controls, and isotype controls
- Multicolor testing: Panels are evaluated for steric hindrance, allowing the optimization of reagent addition order
- Protocol development: A detailed staining and acquisition protocol is provided
Panel Validation
Validation is critical to ensure your panel performs reliably under real-world conditions and is conducted in accordance with Clinical & Laboratory Standards Institute (CLSI) Document H62 guidelines:
- Precision: Assess intra- and inter-assay reproducibility (e.g., CV < 20% for major populations)
- LLOD: Lower Limit of Detection
- LLOQ: Lower Limit of Quantitation
- Specificity: Demonstrate no significant non-specific binding or cross-reactivity
- Stability: Evaluate sample stability and anti-coagulant preference for whole blood (EDTA, sodium heparin, Cyto-Chex® BCT tubes upon request); evaluate post-stain stability or Cytodelics cryopreserved sample upon request
- Sample types: Optimize sample type for intended use
- Five independent analytical runs: Data generation
- Fluorescence-minus-one (FMO) controls: Assess spillover and Limit of Blank (LOB), as required
- Data analysis:
- Perform spectral unmixing and analysis using SpectroFlo® software
- Perform additional analysis in OMIQ or FCS Express software as required
- Deliverables:
- Validation plan: Detailed plan submitted for approval prior to execution
- Validation report: Summary of results for each population outlined in the validation plan
- Gating guide & analysis template(s)
- Raw data: FCS files
- Normal sample reference ranges
Custom Conjugation
Our world-class team specializes in providing custom antibody conjugations that enable panel optimization and implementation. Once these custom reagents are integrated into an ongoing program, we ensure a secure supply during panel use with a multi-year agreement.
- Expertise: Our team is comprised of flow cytometry specialists with years of experience in spectral technologies
- Customization: Every panel is designed to meet your unique needs, including custom conjugation
- State-of-the-art technology: Cytek Full Spectrum Profiling™ flow cytometers are used for development and validation
- Collaborative approach: We work closely with you at every step, ensuring transparency and alignment with your goals
Applications
Our services support a wide range of applications, including:
- Exploratory panels for translational science
- Immunophenotyping of complex cell populations (e.g., immune cells, cancer cells)
- High-dimensional biomarker discovery (e.g., 40-50 markers)
- Biomonitoring for cell and gene therapy
- Backbone panels with guidelines for marker addition
Samples Supported
Our services support a wide range of sample formats:
- Tumor in transport media (with enzymatic dissociation performed by Cytek)
- Whole blood in EDTA, heparin, acid-citrate-dextrose (ACD), sodium citrate, and Cyto-Chex® tubes
- Lymph node (stored in cold RPMI/shipped overnight; with enzymatic dissociation performed by Cytek)
- Bone-marrow
- Cryopreserved PBMCs
- Cytodelics stabilized cryopreserved whole blood
Process Overview
- Consultation: We begin with a detailed discussion of your project goals, sample types, and instrumentation
- Design phase: A preliminary panel designed and refined based on your feedback
- Development phase: The panel is brought up and optimized in our lab
- Validation phase: Rigorous testing ensures performance meets your specifications
- Delivery: You receive the validated panel, protocols, and supporting documentation
Meet One Of Our Experts
Mark Edinger, Vice President of Scientific Affairs
Mark began his flow cytometry career at the Cleveland Clinic Foundation (CCF) where he instituted flow cytometry in the late 1970’s. During his tenure at CCF he developed some of the techniques and assays employed for clinical practice and academic research used today. While at CCF, Mark was also a consultant for Becton Dickinson (BD) and in 1998 formally joined BD Biosciences, where he founded and managed the Technical Applications Group, and later founded the R&D Systems Validation Laboratory. While at BD, collaborating with scientists at Amgen, Mark developed the whole blood phosphoprotein lysing buffer that is used daily in labs throughout the world. He was also a member of the team that produced CS&T beads and the software that provided automated instrument standardization for the first time. Mark joined Quintiles/IQVIA in 2012 where he developed and established quantitative standardization of flow cytometers, along with other state of the art practices, making IQVIA flow cytometry laboratories the first to offer this level of instrument standardization for global laboratories. Mark implemented next generation full spectrum flow cytometry at IQVIA Laboratories with the placement and integration of Cytek Aurora™ full spectrum instruments in the seven IQVIA Laboratories in the United States, United Kingdom, China, Japan, Singapore, and India. Mark joined Cytek Biosciences in January 2021, where he is working to develop complete integrated systems solutions for flow cytometry.
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For Research Use Only. Not for use in diagnostic or therapeutic procedures.