Modern immunology research requires high-complexity panels available wherever the patients are located. Deploying advanced flow cytometry instruments and panels across multiple global sites is therefore a transformative step in harmonizing immunological research and clinical trials.
KCAS Bio has worked closely with Cytek to make this a reality by validating the performance of the 15-color Pan-Leukocyte Panel at all three locations. This promises to bring the power of consistent and comprehensive leukocyte profiling to human whole blood when it cannot be centralized for analysis at a single site. With its robust validation and precision, this panel enables comprehensive and standardized immune monitoring across diverse locations, making it an ideal choice for rapidly changing multi-regional studies.
A Global Platform for Success
The easiest way to ensure harmonization between flow cytometry instruments is to build all of the instruments with that purpose in mind. Towards that end, KCAS Bio was one of the first participants in Cytek’s Harmonization Qualification program, in which multiple units were compared to ensure only the instruments with precisely aligned laser and detector performance criteria were placed at each site.
Once installed, the instruments underwent additional rigorous performance qualification to ensure that the instruments delivered results according to the exacting standards at KCAS. Finally, a global procedure was put in place to maintain calibration at all sites moving forward, with detailed protocols for daily setup and regular performance monitoring.
Three Sites, Two Companies, One Procedure
Effective deployment also requires equipping local teams with the skills to execute the panel’s protocols with precision. KCAS Bio invested heavily in this process by sending the same scientist to oversee work as it was being completed at each site to eliminate any loss of data during transfers. While not required for every transfer, this process was essential to establish a common understanding of systems and options between sites and helped expedite the adoption of globally harmonized processes.
After the training was complete, regular project and harmonization meetings were established to ensure on-going scientific communication between sites and to maintain global documentation. Collaboration between the sites fosters a knowledge-sharing culture, enabling problem-solving and continuous improvement.
Advantages for Clients- Time and Flexibility
Implementing this panel at three distinct global sites in the United States, Europe, and Asia presents opportunities to rapidly initiate or modify studies as clinical requirements change. Barriers such as assay development time, instrument calibration, and training have been removed, allowing for study starts in as little as 2 weeks after contracting.
Once a study is initiated, the ability to integrate data across regions seamlessly simplifies sample logistics. The panel’s validated stability for more than 72 hours post-collection for some markers simplifies sample transport between sites and central laboratories. This feature is critical for studies involving remote or resource-limited locations, ensuring sample integrity during transit. Standardized storage and transport conditions, paired with clear communication channels, prevent data loss and enhance efficiency.
A multisite deployment amplifies the panel’s utility in global clinical trials, enabling diverse participant recruitment alongside robust immune profiling. The standardized data generated across sites supports regulatory submissions, accelerates drug development timelines, and enhances translational research outcomes.
KCAS Bio has succeeded at removing traditional barriers to multisite flow cytometry resulting in accelerating study start times, ensuring data consistency, and enabling global trial scalability.
Ready to take your global immunology studies to the next level? Partner with KCAS Bio to leverage our validated multisite flow cytometry platform and accelerate your path from discovery to regulatory success. Contact us today to learn how we can support your next clinical trial.