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Poster – Validation Of NanoString® Technologies For Solid Tumor Clinical Studies

Cerba Research Montpellier (CRM), a leader in histopathology and part of the Cerba Research group, is revolutionizing solid tumor clinical trials with our cutting-edge NanoString® platforms. Specializing in multiplex immunofluorescence for FFPE tissues, our lab now offers unparalleled transcriptomic and proteomic analysis capabilities.

Transforming Solid Tumor Clinical Trials with NanoString® Technology

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.

NanoString’s nCounter Pro analysis system

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Poster – Implementation Of Cytek® Aurora Instruments In Clinical Trials: A Multi-step Process Including Performance Qualification And Standardization


Experience the power of Cytek® Aurora instruments in global clinical trials. Our multi-step process, led by a team from Cerba Research and Cytek Biosciences, focuses on performance qualification and standardization to unlock the full potential of high-parameter spectral flow cytometry. Explore our journey through performance qualification, assessing optical alignment, system resolution, stability of lasers and detectors, and analytical validation.

Harmonizing Excellence: Unleashing High-Parameter Spectral Flow Cytometry in Global Clinical Trials with Cytek® Aurora Instruments

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.

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Poster – Validation Of A Flow Cytometry Assay On Cytek® Aurora To Monitor Immune Cells In Peripheral Whole Blood For Clinical Trials

Discover the cutting-edge of immune monitoring in global clinical trials. Our 14-color assay, validated meticulously for hematological malignancies, utilizes spectral flow cytometry for a comprehensive understanding of T cells, B cells, NK cells, monocytes, and subsets. Elevate standards in drug development and improve patient outcomes worldwide.

Advancing Immune Monitoring: Validation of a 14-color Assay for Hematological Malignancies and Cell & Gene Therapy 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.

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Poster – Comparison Of BD FACSLyric™ Instrument Performance In A Global Setting

Flow cytometry, recognized for its unparalleled capacity in characterizing cellular populations, necessitates the implementation of standardized instruments both within and across various laboratories, particularly for conducting global clinical trials. A pivotal component in achieving this standardization is the Cytometer Setup & QC software featured in the BD FACSLyric™ instrument. This software is engineered to correct daily fluctuations not only within a single instrument but also across multiple instruments, leveraging the Bright Bead Median Target Values (BBMTV).

Enhancing Standardization in Flow Cytometry for Global Clinical Trials

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.

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Poster – Development And Validation Of Flow Cytometry Assays For Autologous And Allogenic CAR T In Global Clinical Programs

The advancement in cell and gene therapies, particularly chimeric antigen receptor (CAR) T cell therapy, marks a significant breakthrough. A prevalent approach in current CAR T cell therapies involves using the patient’s own modified T cells, known as autologous CAR T cells. However, due to their cost-effectiveness and ready availability, there is an increasing shift towards next-generation allogeneic CAR T cells in clinical trials. These allogeneic CAR T cells are derived from healthy donors and engineered for therapeutic use.

Innovative Techniques for CAR T Cell Detection and Monitoring

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.

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Case Study – Revolutionizing Flow Cytometry: The Development Of A Ki-67 Expressing Cell Mimic For Advanced Assay Validation

In the rapidly evolving landscape of immuno-oncology research, Cerba Research has set a new standard with its latest project in collaboration with Slingshot Biosciences. This case study delves into the critical challenges and innovative solutions in the realm of flow cytometry and assay validation. At the heart of this groundbreaking project was the development of a Ki-67 expressing cell mimic, a crucial tool for advancing flow cytometry assays.

Overcoming The Scarcity Of Ki-67 Expressing Cells

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.

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White Paper – The Importance Of NGS Panel Customization For Your Assays: Good Practices And Key Takeaways

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.

 

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Brochure – Your Preferred Virology Contract Research Organization

Elevate your research and development with exceptional preclinical and clinical test services.

At Cerba Research we stand as your ideal virology contract research organization, redefining excellence in preclinical and clinical testing. Our commitment to innovation and precision drives us to deliver exceptional solutions for vaccines, antivirals, and diagnostics development.

Dive into our arsenal of clinical diagnostic services, including serology assays, molecular assays, and more, all designed to elevate your research.

Discover all our capabilities in our Virology & Vaccine Lab Brochure.

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Case Study – Evaluation Of Precision Of Quantitative Measurement Procedures: Support For CE IVD Marking For An Immunoassay Instrument

The concept of analytical performance includes different parameters that must be considered in the context of ensuring the quality, safety, and efficacy of an IVD device before placing it on the market. One of these parameters is precision (repeatability and reproducibility) which is summarized as the agreement between different independent measurement results of a sample in a series of measurements or between different series of measurements. Our customer sought our expertise to meet predetermined accuracy requirements on 26 parameters in the areas of bacterial infectious diseases, prenatal screening, oncology, and endocrinology to obtain CE marking for this instrument.

Discover the whole story in the case study below

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Webinar – Cytek Aurora Instrument Standardization For Patient Testing In Global Clinical Trials

Recently Cerba Research’s Regional Head of Flow Cytometry, Veronica Nash, PhD, presented at CYTO 2023 and talks through Cerba’s work on Cytek Aurora instrument standardization for patient testing with the purpose of using them for global clinical trials.

Discover the full video here

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