In the ever-evolving landscape of healthcare, Cell and Gene Therapy (CGT) stands at the forefront of groundbreaking advancements. With the power to precisely manipulate cells and genes for therapeutic purposes, CGT offers immense promise in treating diseases at their root.

In the whitepaper “Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio.”  we dive into the critical realm of patient safety within CGT. Authored by industry experts, this comprehensive guide presents a novel approach to patient safety monitoring, fusing breakthroughs in flow cytometry and genomics solutions.

Key Topics Covered:

🔍 Understanding the Risks: Ensuring Patient Safety: As CGT continues to revolutionize medicine, it’s imperative to acknowledge the inherent risks associated with these therapies. From the potential for insertional oncogenesis to the emergence of replication-competent viruses, safeguarding patient safety remains paramount.

📊 Key Capabilities: Vector Copy Number (VCN) Testing, Viral Integration Site (VIS) Analysis, Replication Competent Virus Testing, Immunophenotyping and Enumeration.

⚖️ FDA Concerns: FDA’s requirements to ensure safety and adverse events

Our recent acquisition of NanoString® technology enhances precision in solid tumor research. We have validated RNA analysis protocols for both bulk analysis using nCounter and spatial analysis with the GeoMx DSP platform’s whole transcriptome atlas (WTA). This advancement opens new doors in cancer research, extending potentially to other therapeutic areas.

Delve deeper into our innovative approach and its impact on solid tumor clinical trials by exploring our poster from SITC 2023. It showcases our advanced techniques and their applications in transformative cancer research.

Explore the intersection of high-parameter spectral flow cytometry and global clinical trials through our meticulous process at Cerba Research, Ghent, Belgium, and Cytek Biosciences, California, USA. We delve into instrument standardization’s critical role for transparent results across labs and introduce innovative methods for implementing and standardizing Cytek® Aurora Instruments.

Witness our multi-step process, evaluating optical alignment, system resolution, laser and detector stability, and analytical validation. Our in-house workflow ensures precision, with deviations well within acceptance criteria. Discover the effectiveness of SpectraComp® beads for spectral unmixing, reducing errors and optimizing workflow.

Join us as we demonstrate instrument comparability and consistent performance, propelling forward the standardization of Cytek® Aurora Instruments for reliable insights in global clinical trials.

Explore our validated 14-color assay, a breakthrough in immune monitoring for hematological malignancies and cell & gene therapy trials. Using spectral flow cytometry, our method offers in-depth characterization of T cells, B cells, NK cells, and monocytes, crucial for global clinical trials.

The assay’s precision, demonstrated through repeatability, reproducibility, and inter-operator variability, ensures reliable data interpretation. Notably, viability dye titration and sample stability evaluations enhance the assay’s robustness.

Our commitment to advancing drug development is exemplified through this cutting-edge flow cytometry assay, providing a comprehensive and reliable tool for monitoring immune cells in peripheral whole blood across diverse clinical settings.

In our efforts to validate the efficacy of this software module in standardizing flow cytometry assays, we undertook a comprehensive evaluation. This involved assessing the Median Fluorescence Intensity (MFI) both between different instruments and within the same instrument over time. For this purpose, we utilized two distinct types of calibration particles: BD® Cytometer Setup and Tracking (CS&T) beads, provided by BD Biosciences, and SPHERO™ Ultra Rainbow calibration particles, from Spherotech.

The focus on maintaining consistent performance in flow cytometry, through the use of advanced software and calibration methods, is crucial in ensuring the reliability and accuracy of results obtained from these sophisticated instruments. This is especially significant in the context of global clinical trials, where standardization across different settings is key to obtaining universally applicable and credible data.

For the detection and monitoring of CAR T cells in patients, two main techniques are employed: PCR and flow cytometry. Flow cytometry, however, stands out for its ability to determine the phenotype of CAR T cells. This feature of flow cytometry is vital for assessing the expansion and persistence of CAR T cells in patients, aligning with the FDA’s draft guidance recommendations. The role of flow cytometry extends beyond detection to playing a pivotal role in monitoring CAR T cells during clinical trials. It enables investigators to gain deeper insights into the behavior of CAR T cells post-infusion and their interaction with the patient’s endogenous immune system. Understanding these dynamics is crucial for evaluating the efficacy and safety of CAR T cell therapies.

In summary, flow cytometry is not just a tool for detection; it is a critical component in the advancement and monitoring of CAR T cell therapies, offering invaluable insights into the therapeutic potential and interaction of these engineered cells within the patient’s immune system.

In this poster, first presented at ESCCA 2023, discover how Cerba Research has implemented both autologous and allogenic CAR T assays.

Addressing a significant gap in the market, this collaboration aimed to overcome the limitations posed by the scarcity of Ki-67 expressing cells in standard biological samples. The synergy between Cerba Research’s expertise in clinical trial services and Slingshot Biosciences’ cutting-edge technology led to the creation of a custom-made Ki-67 cell mimic.

This solution not only met but exceeded the expectations in assay validation, showcasing a leap forward in flow cytometry techniques. This case study highlights the transformative impact of this project, marking a milestone in assay validation and flow cytometry applications in clinical research.

As cancer remains a major global health concern, precision medicine brings hope for patients for improved treatments and outcomes. Explore the pivotal role of Next-Generation Sequencing (NGS) panel customization in driving advancements in oncology research. From biomarker identification to actionable mutation detection, molecular profiling forms the bedrock of precision medicine. Learn how NGS panel customization is revolutionizing this landscape, enabling simultaneous analysis of diverse genetic aberrations for a comprehensive cancer understanding.

Traditional methods like Sanger sequencing and PCR are limited to single-gene analysis, making them impractical for new target discovery. NGS’s ability to analyse millions of segments in parallel accelerates research, while customized panels provide deeper, cost-effective insights into genomic abnormalities.

Discover insights on:

1. NGS Advantages: Delve into the superiority of NGS over traditional methods, facilitating efficient and sensitive analysis.
2. Clinical Implementation: See how NGS is enhancing patient care through improved molecular profiling in clinical trials and practice.
3. Personalized Therapies: Understand how tailored panels enable personalized and precise targeted therapies by identifying actionable mutations.
4. Latest Techniques: Explore the application of NGS to formalin-fixed paraffin-embedded (FFPE) samples and the innovative use of circulating tumor DNA (ctDNA).

Elevate your understanding of precision oncology’s potential. Download our white paper to harness the benefits of NGS panel customization. Empower your oncology research and clinical practice with insights that will help transform your research and advance health for patients.