Accellix™ and Streck Forge Strategic Alliance to Elevate Quality Control Standards in Cell Therapy Through Integrated Flow Cytometry Solutions
In a significant move poised to reshape quality assurance practices in the rapidly evolving field of cell therapy, Accellix™, a trailblazer in automated flow cytometry, has announced a strategic collaboration with Streck, a globally recognized leader in the development of quality control (QC) materials for flow cytometry, hematology, and molecular diagnostics. This partnership centers on the integration of Streck’s CD-Chex Plus® (RUO) control into the Accellix Automated Cell Phenotyping Platform—a compact, fully automated flow cytometer engineered for point-of-need applications. The alliance underscores a shared vision: to deliver robust, simplified, and reliable quality control solutions that empower cell therapy developers, clinical laboratories, and manufacturing facilities to generate trustworthy data with unprecedented ease and speed.
The Accellix platform represents a paradigm shift in flow cytometry. Traditionally, flow cytometry has been a complex, labor-intensive process requiring highly trained personnel, extensive sample preparation, and sophisticated instrumentation typically housed in centralized core laboratories. In contrast, the Accellix system is purpose-built for decentralized, near-patient, or manufacturing environments where speed, consistency, and operational simplicity are paramount. At the heart of its innovation lies a single-use, microfluidic cartridge that seamlessly automates the entire cell phenotyping workflow—from antibody staining and cell washing to flow cytometric acquisition and real-time data analysis. This end-to-end automation eliminates many of the manual steps and variables that can introduce error or inconsistency, thereby ensuring highly reproducible results across users, shifts, and locations.
The newly announced integration of Streck’s CD-Chex Plus (RUO) control into the Accellix ecosystem marks a critical advancement in quality assurance for cell therapy applications. CD-Chex Plus is a well-established, lyophilized whole blood control designed to mimic patient samples and provide consistent, stable performance across a broad range of immunophenotyping assays. It contains stabilized white blood cells expressing key surface markers commonly used in clinical and research flow cytometry panels, including those critical for characterizing immune cell subsets in cell therapy products—such as T cells (CD3, CD4, CD8), B cells (CD19), and natural killer cells (CD16/56). By incorporating this trusted QC material directly into the Accellix workflow, users gain a powerful tool to routinely verify instrument performance, reagent integrity, and assay consistency without disrupting their existing processes.
This integration is particularly transformative for cell therapy manufacturing and quality control labs, where regulatory compliance, product consistency, and rapid turnaround times are non-negotiable. Cell therapies—such as CAR-T cells, TCR-engineered T cells, and other advanced therapeutic medicinal products (ATMPs)—require rigorous characterization at multiple stages of production. Flow cytometry is indispensable in this context, used to confirm identity, purity, potency, and viability of therapeutic cell products. However, ensuring the reliability of flow cytometry data in decentralized or GMP-compliant environments has historically been challenging due to instrument variability, operator-dependent protocols, and the lack of standardized QC materials compatible with automated platforms.
The Accellix–Streck collaboration directly addresses these challenges. With CD-Chex Plus (RUO) now validated for use on the Accellix platform, laboratories can perform daily or batch-based QC checks with minimal effort. The control is simply processed through the same microfluidic cartridge as patient or product samples, generating comparable data that reflects real-world assay conditions. This eliminates the need for separate QC runs on different instruments or complex calibration procedures. Moreover, because the Accellix system automates data acquisition and analysis, QC results are generated rapidly and objectively, reducing the risk of human error and enabling immediate corrective actions if deviations are detected.
Rey Mali, Chief Operations Officer at Accellix, emphasized the strategic importance of this partnership: “This collaboration reflects our unwavering commitment to helping cell therapy developers and laboratories worldwide achieve faster, more reliable results. By aligning with Streck—a company synonymous with quality and consistency in diagnostic controls—and integrating their CD-Chex Plus (RUO) control into our platform, we’re making it significantly easier to implement standardized, instrument-agnostic quality control across diverse settings. Whether in a hospital-based cell processing lab, a biotech startup, or a large-scale manufacturing facility, users can now maintain confidence in their data without adding complexity or relying on centralized infrastructure.”
Matt Thummel, Director of Business Segment – Hematology, Body Fluids and Flow Cytometry at Streck, echoed this sentiment, highlighting the synergy between the two companies’ missions: “We’re excited to work with a team that shares our dedication to supporting laboratories and biopharmaceutical companies with reliable, streamlined solutions that drive positive outcomes in healthcare. Adding the Accellix platform to the list of instruments compatible with CD-Chex Plus (RUO) gives users a dependable, standardized method to monitor performance and maintain confidence in their results—especially in fast-paced, high-stakes environments like cell therapy manufacturing, where every minute and every data point matters.”
The implications of this collaboration extend beyond operational efficiency. As the cell therapy market continues to expand—with hundreds of clinical trials underway and an increasing number of commercial products gaining regulatory approval—the demand for robust, scalable, and compliant analytical methods is intensifying. Regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), emphasize the importance of process validation and ongoing quality monitoring in cell therapy production. The Accellix–Streck solution directly supports these regulatory expectations by providing a traceable, consistent QC framework that can be seamlessly embedded into GMP workflows.
Furthermore, the user-friendly nature of the Accellix platform lowers the barrier to entry for smaller labs or institutions that may lack access to core flow cytometry facilities. By enabling high-quality immunophenotyping at the point of need—whether in a cleanroom, a hospital lab, or a research bench—this technology democratizes access to critical analytical capabilities. When paired with a gold-standard control like CD-Chex Plus, it ensures that data generated in these decentralized settings meets the same rigorous standards as those produced in centralized reference labs.
the partnership between Accellix and Streck sets a precedent for future integrations in the diagnostics and cell therapy space. It exemplifies how collaboration between instrument developers and reagent/control manufacturers can yield holistic solutions that address real-world pain points. As cell therapies become more personalized and complex—requiring multi-parameter characterization and real-time monitoring—the need for integrated, automated, and quality-assured platforms will only grow.
