Phase 4 Archives - Cerba Research

Being one of the leading technologies for cellular analysis, flow cytometry generates simultaneous high-throughput enumeration and individual cell characterization data. With the breakthrough of cellular immune therapies, such as CAR+ T, flow cytometry became a critical platform, not only for clinical laboratories, but also for drug developers and manufacturers.

Flow cytometry plays a crucial role in the production process of CAR+ T cells, where it is used for assessing transduction efficiency, purity, and characterization of the CAR+ T product before infusion. After manufacturing, when CAR+ T cells are infused into the patients, flow cytometry is used again in clinical laboratories to assess CAR+ T expansion, efficiency, and persistence and to monitor minimal residual disease (MRD).

In this e-book, Ans De Beuckelaer, Regional Head Flow Cytometry EU and Rowan Claeys, Clinical Biologist at Cerba Research, dive deeper into key elements of flow cytometry:

The importance of flow cytometry in Car+T clinical research and its uses
Key aspects in developing a CAR+ T trial
The added value of flow cytometryin multiple myeloma, Minimal Residual Disease (MRD) assessments and multiple Myeloma phenotype
Car+T-cell Therapy: patient treatment, targeted antigens and solutions for MRD assessments and multiple myeloma phenotype assessment.

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Ebook – CAR+T Drug Development The Critical Role of Flow Cytometry

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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.

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Tour our IHC Centre of Excellence in 360°

Cerba Research - Montpellier IHC Lab Tour

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A late-stage biopharmaceutical company dedicated to metabolic and chronic liver diseases is developing an in vitro diagnostic (IVD) test for NASH at-risk patients. The test integrates four independent biomarkers – miR-34a-5p, A2M, YKL-40, and HbA1c. The output is a 0-10 score with threshold values, identifying patients with low risk or high risk of developing NASH.

The main objective of this study is to evaluate the physiological stability of these biomarkers between the fed and fasting state in patients with the target condition (NAFLD) over a 30-day period.

Discover how our team of experts helped this biopharmaceutical company to reach its goals

Case Study – A blood-based biomarker panel for non-invasive diagnosis of non-alcoholic steatohepatitis: a multi-centre prospective and validation study

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In immuno-oncology (I/O), meeting budget and timeline expectations in the journey from translational research to commercialization is a challenge. You need expert, integrated clinical laboratory and diagnostic solutions delivered by top scientists who will help you assess needs and generate early insights that optimize your protocol.

What else should you look for in a clinical laboratory partner? Along with access to a sizable patient database, impeccable performance across the globe, and I/O experience, three main testing capabilities are mandatory for success in this field: immunohistochemistry, flow cytometry, and next generation sequencing.

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White Paper – Nonnegotiable Central Laboratory Capabilities for I/O Clinical Trial Success

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The challenges in immuno-oncology (I/O) drug development require deep scientific insights, generation and analysis of complex biological data, new state-of-the art technologies and both logistical & operational support across continents. The goal of immuno-oncology drug developers is to turn precision medicine into action, bringing life-changing therapies to patients.

In this webinar originally held on October 4 our experts discuss the use of Immunohistochemistry (IHC), Next-Generation Sequencing (NGS), and Flow Cytometry (FCM) within immuno-oncology, and how they can offer the comprehensive insights required for I/O clinical trials.

Speakers

Jérôme Sallette, PhD, CSO Cerba Research
Shu Jen Chen, PhD, CSO ACT Genomics
Sofie Vandevyver, PhD, Head of Business Operations & Marketing Cerba Research
George Wei, PhD, Vice President R&D ACT Genomics
Renaud Burrer, PhD, Head of Histopathology Cerba Research
Nithianandan Selliah, PhD, Global Head Flow Cytometry Cerba Research