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White paper – Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

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

And much more! Complete the form below to download the white paper now!

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Resource Library

Brochure – Meeting The Challenges You Face With PBMC- All Your Global PBMC Needs Delivered

There are important questions you need to ask yourself and any potential laboratory partner before you start a study including PBMC assays as part of your protocol. When looking at the laboratory partner for your PBMC processing, approaching potential partners with the end in mind is important to ensure that you will be able to generate the data you need in the future.

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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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Resource Library

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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Resource Library

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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Presentation – Translating Scientific Challenges Into Scientific Challenges Into Preclinical Research Solution

Resource Library

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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Reach out to our experts and discover how we can help you transform research and advance health in the field of genomics.

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