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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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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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Poster – Workflow And Troubleshooting For Performance Qualification Of Cytek Aurora Instrument In A Clinical Setting

The ability of developing high-parameter assays allows for a deeper characterization of patients’ immune subsets with limited sample availability. Spectral flow cytometry is used to assess high-parameter immune profiling in global clinical trials. To date, there are no specific guidelines for Performance Qualification (PQ) of spectral flow cytometers. Here, we describe an in-house developed workflow for performing PQ of a Cytek® Aurora instrument in a clinical laboratory.

Cerba Research US - Flow Cytometry Cytek Aurora

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Poster – Upscaling Of A Clinical Flow Cytometry Laboratory

As flow cytometry is one of the go-to methods for fast and in-depth monitoring of immune cell populations at single cell level, clinical laboratories are observing an increase in assay complexity and number of samples to process. To scale up our operations in a qualitative and efficient manner, several aspects of the laboratory design were improved and are discussed below.

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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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E-book – CAR+T Drug Development The Critical Role Of Flow Cytometry

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.
Cerba Research - Ebook - CAR+T Drug Development The Critical Role of Flow Cytometry
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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

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

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 central 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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Webinar – Turning Precision Medicine Into Action In Immuno-Oncology

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

Resource Library

Flyer – CerbACT Asia – Center Of Excellence In Immuno-Oncology

CerbACT Asia empowers precision medicine development and drives better patient outcomes by applying deep biomarker expertise to research & clinical development strategies, combining the strengths of Cerba Research and ACT Genomics. We are enabled by cutting edge technologies in Flow Cytometry (FCM), Immunohistochemistry (IHC), and PBMC/cell isolations, while functioning as a central laboratory in the APAC region. Working with biotech, pharma, government and nongovernmental organizations, our team is ready to turn precision medicine into action!

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