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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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White Paper – Precision Medicine For Non-Small Cell Lung Cancer (NSCLC) – Emerging Trends In Molecular Analysis

Of all types of cancer, lung cancer caused more deaths worldwide than any other type of cancer. It also causes more deaths than breast and colorectal cancers combined. Patients with the most common lung cancer, non-small cell lung cancer (NSCLC), have higher survival rates than patients with small-cell lung cancer (SCLC), but the outcomes for both remain bleak. According to the National Cancer Institute, the five-year survival rate for NSCLC between 2004 and 2010 was 20.7% compared to only 6.3% for SCLC.2

NSCLC patients also have more promising and more precise, treatment options today compared to even 10 years ago. Advances in biomarker and precision medicine have led to the development of immunotherapies and targeted novel treatments that have the potential to improve patient outcomes. In the United States, the FDA has approved dozens of biomarker-driven therapies for NSCLC, including ALK, EGFR, and ROS1 inhibitors. Meanwhile, more than 1,200 treatments are in development.

Discover the latest trends in precision medicine for NSCLC in this white paper

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Brochure – Cerba Research Genomics Experience In Oncology

Since 1992, Cerba Research/Healthcare has pioneered the art of human genetic testing, Cerba Healthcare builds the start of the art in human genetic testing by being the first laboratory in Europe to introduce Genetic testing.

Thanks to this experience, we are able to collaborate with the life science community to provide the most suitable genomic service and enhance the power of your genetic material.

Cerba Research can work with you to select the most suitable platform and assay to reach your project expectations.

Discover all our capabilities in our latest Genomics Brochure

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Presentation – Automatization Of Immunohistochemistry Data Analysis For Protocol Validation

This presentation was given by Marie Gerus-Durand, Principal Scientist & Validation Engineer at Cerba Research Montpellier at the JMP Discovery Summit Europe.

Cerba Research is a global company providing high-quality, specialized analytical and diagnostic solutions for clinical trials. Cerba Research Montpellier develops customized immunohistochemistry protocols to detect the expression of selected targets on patients’ tissue sections.

To be used in clinical trials, these protocols must meet the regulatory agencies’ criteria to ensure that the protocol will allow consistent results on precious patients’ samples. With the diversity of parameters evaluated and the types of evaluation possible in implementing these custom protocols, automating data analysis became a need.

Thanks to various JMP® tools, we have developed an automated analysis that saves time and homogenizes protocol performance reports by including statistical and graphical data in a Dashboard. This process, submitted as JMP Add-in, has been incorporated into our user workflows, thus facilitating our procedures.

Tour our IHC Centre of Excellence in 360°

Cerba Research takes you on a 360 degree tour of their IHC Centre of Excellence lab

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Webinar – The Added Value Of Flow Cytometry In CAR T-Cell Clinical Trials Webinar

Watch Cerba Research’s latest webinar, ‘The Added Value of Flow Cytometry in CAR T-Cell Clinical Trials’.

The Added Value of Flow Cytometry in CAR T Cell Clinical Trials

Resource Library

Webinar – In Light Of NASH: Liver Biopsy Optimization Webinar

Liver biopsies are the gold standard for Non-Alcoholic Steatohepatitis diagnosis and thus essential to NASH clinical trials, yet obtaining them is invasive, can be painful and comes with risk of complications. Making optimal use of these valuable samples is therefore critical.

In this webinar, our experts will highlight possible ways to get the most out of liver biopsies and moreover, provide an overview of alternative methodologies.

The presenters will discuss available stainings of liver biopsies for diagnosing NASH, how alternative and innovative imaging can facilitate pathologists’ reading of the samples and how the placebo effect can impact study results. Together, they will lead the discussion on how to determine the best process for trials and boost the optimal use of liver biopsies for studies.


Fanny Estermann, PhD, Biomarker Study Team Leader, Cerba Research Montpellier

Fanny Estermann holds a PhD in Biology. She conducted successfully her work on oncolytic viruses at Salk Institute for Biological Studies (La Jolla, CA, USA), paving the way for a new type of targeted cancer therapy. As a specialist in cancer research, she then worked on senescence, cancer and metabolism at the Cancer Institute of Montpellier (ICM, France). She focused her work on metabolism dysfunctions and its consequences in the global health and cancers. She then joined the Montpellier’s University Hospital center (IRMB, France) to develop cutting-edge stem cell, cancer and senescence techniques. After gathering extensive experience in cancer research, stem cells and metabolism, she received a degree in Clinical Trials from the University of Medicine of Montpellier before joining Cerba Research, as Biomarker Study Team Leader and Regional Head of Project Management. Her main goal with her team is to deliver high quality results to clients by designing and conducting custom scientific projects to fit clients’ needs in preclinical and clinical trials. She has been closely involved in the management and development of Cerba Research biopsy processing and new stainings. She is a direct interlocutor of many NASH KOL.

Manon Motte, Head of Image Analysis, Cerba Research Montpellier

Graduated as Master in Skin Biology at the University of Lyon, Manon worked for more than 7 years in the pharmaceutical industry in a Morphology Histologic team (R&D department) for Dermatological projects. She has a strong experience in the implementation of transverse Histology/Omics technology as well as in the validation of Image analysis applications (Pre-clinical and clinical Studies). Manon is also a specialist in histological techniques and related processes. Today, Manon has chosen to extend her experience in the histology and immunohistochemistry department of Cerba Research as an imaging manager and ensures compliance with GLP and ISO17025 standards in order to ensure maximum reliability in the results delivered to our customers. Manon leads the team advancing NASH associated imaging solutions to assist in the pathologist’s evaluation at Cerba Research. This development includes the evolution of digital pathology and software assisted analyses specific for NASH histological stains and their associated scores.

Pablo Ortiz, MD, PhD, Chief Scientific Officer, OWL Metabolomics

Pablo Ortiz became MD by Universidad Autónoma of Madrid (1972-1978) where he also achieved his PhD (1984-1990, Cum Laude) and Postgraduate with Honors in the Autonomous of Barcelona University about “Biostatistics in Medicine” (1980-1981). Pablo Ortiz graduated as an MD from Universidad Autónoma in Madrid (‘72-’78), after which he continued to a Postgraduate with Honors in Biostatistics in Medicine at the Barcelona University (‘80-’81). He also holds a PhD in Biostatistics in Medicine, obtained from Universidad Autónoma.
Pablo has extensive training in managing R&D projects and clinical trials, and over 25 years of experience (1979-2004) within the Medical Department of Boehringer Ingelheim. He was named Honorary Professor at the Faculty of Medicine of Málaga University in 2000 and from 2008 to 2011, and currently teaches in the Master’s in Biotechnology program at the University Pompeu Fabra of Barcelona.  From June 2004 until November 2012, he was CEO at Digna Biotech, a company created as a spin-off of University of Navarra, which he left with 4 clinical-Stage Products (1 small peptide, 2 proteins and 1 viral vector). He was member of the Board of Trustees in Fundación Moderna (Goverment of Navarra) and 2 Biotechs companies (Bionure and ProRetina) from 2010 to 2011. From January 2013 to date, Pablo is head of the Biotech division at Pivotal (Clinical CRO). He joined OWL in January 2013 as a senior consultant, in June 2014 as Chief Executive Officer and is currently its Chief Scientific Officer. He has published more than 30 papers in international peer-reviewed journals.

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