Analyzing Multiple Biomarkers with IHC: putting a 6-plex kit to the challenge
On November 16, 2021 Cerba Research and Akoya Biosciences held a webinar on how to analyze multiple biomarkers using Immunohistochemistry (IHC). The session was a deep dive in the Tissue Microenvironment (TME) with multiplex IF (Opal™) technology, discovering how to visualize, analyze, and quantify multiple phenotypes in situ.
As part of a long-standing collaboration with Akoya Biosciences, we agreed to test our pre-validated 6-plex panel kits, including one suitable for carcinoma immune-contexture investigations (CD8, CD68, FoxP3, PD1, PD-L1, PanCK). We were also able to put into practice Akoya’s pre-set imaging protocol on the Vectra® Polaris™ and related data analysis algorithm with inForm® software.
- Ivan Masetto, PhD, Field Application Scientist South of Europe at Akoya Biosciences
- Maroua Tliba, Image Analyst at Cerba Research
The Value of Biomarkers from Discovery to Commercialization
Why do some patients respond to therapy while others do not? The answer can be found in the concept of biomarkers: objective, measurable indicators of the
presence or severity of disease. Used for decades to aid medical diagnosis, researchers today use biomarkers in every phase of drug discovery and development.
There’s good reason. Biomarkers can triple drug development success rates, accelerating the availability of new therapeutics.
Download our article by Jérôme Sallette, CSO at Cerba Research, to learn more on the advantages of biomarkers in clinical research.
Cerba Research Expands U.S. Immuno-Oncology Center of Excellence to Strengthen Its Precision Medicine Offerings
Cerba Research established its United States presence as a leading clinical diagnostics and clinical laboratory services provider when it opened a New York facility 20 years ago. To further support our global client base, Cerba Research recently expanded this facility — now our U.S. Immuno-Oncology Center of Excellence — which allows us to provide even more comprehensive, integrated central lab services, specialty lab and biomarker solutions, and diagnostic services worldwide.
Over one weekend in July, with no loss in activity, Cerba Research U.S. moved into a 30% larger facility, giving the lab 35,000 more square feet than before. To make best use of that space, the U.S. team brought in additional state-of-the-art equipment, expanded its testing, sample handling and logistics areas, and welcomed additional scientific and operational experts.
“It’s a new space with a lot of light and a lot of color,” says Chief Operating Officer Nele Langenaken, who founded Cerba Research U.S. in 1999. “Overall, it provides a clean, inviting, positive environment, which helps improve efficiency and motivation among staff, as well as helps us attract and retain top scientific talent.”
Cerba Research U.S. will maintain its close partnership with Northwell Health, the largest laboratory in the region. With more than 75 pathologists and a lab that processes more than 30,000 tests per day, its support allows Cerba Research U.S. to manage rapid turnaround and large-volume requests.
That said, its expert scientists and state-of-the-art equipment make Cerba Research U.S. a first choice for precision medicine clinical trials. “The industry is moving from quantity to quality and from routine to specialized,” says Cerba Research Chief Executive Officer Mario Papillon. “Nele created an ideal environment for customized assay development and validation for R&D projects.”
The most exciting updates to Cerba Research U.S. include:
Triple the flow cytometry capacity. The expansion allowed Cerba Research U.S. to more than triple its complex flow cytometry capacity. Equipment additions include automated flow cytometers and full spectrum machines that demonstrate up to 40 colors.
“We not only expanded our capabilities, we also optimized the process and created space for a new level of excellence in flow cytometry,” says Langenaken.
Quadruple the PBMC capacity. Peripheral blood mononuclear cells (PBMCs) are critical components of immunology, infectious disease, and oncology research. With the expansion, Cerba Research U.S. increased PBMC and cell isolation capacity to handle up to four times more sample volume than the previous location.
New histopathology immunohistochemistry (IHC) lab. For the first time, Cerba Research U.S. contains an in-house histopathology lab with tissue processing, cytology, and IHC solutions for biomarker discovery through to clinical validation. Our IHC capabilities include automated, multiplex, and specialized IHC.
Increased kit production. Cerba Research U.S. increased kit production by 40% in 2021 compared to this time last year. The expanded facility will allow it to expand that production even further.
Increased sample reception and storage. The expanded Cerba Research U.S. laboratory receives between 8,000 and 10,000 tubes per day. We expect that number to increase by 20 to 25% over the next few years. Additional storage capacity includes temperatures from ambient to -20°, -80° C, with available liquid nitrogen, all centrally monitored by a temperature monitoring system.
An even stronger team. With the expanded facility comes an expanded team. Additional scientists and operational experts give the U.S. team the depth to handle even the most complex projects.
The expanded flow cytometry, PBMC, and IHC capabilities give the U.S. CoE an even broader global footprint with which to serve immuno-oncology clinical trials. The expansion compliments CerbACT Asia, Cerba Research’s other immuno-oncology Center of Excellence, which offers cutting-edge technology in FCM, histopathology, IHC, and NGS sequencing from a purpose-built facility in Taiwan.
“We have a substantial team of flow cytometry scientists in the U.S., all with high international profiles,” says Papillon. “Combined with the clinical expertise of Northwell Health, our capabilities in North America are remarkable.”
As part of a network that includes seven offices and access to over 400 labs across five continents, you can be certain no matter how global your trial, Cerba Research has the capabilities and capacity to support your projects from early research through to commercialization.
Cerba Research, a strategic provider of diagnostic solutions, supports drug development by leveraging patient data and scientific insight to optimize R&D and commercialization globally. Providing early phase research, clinical development through central laboratory and diagnostic testing, assay and biomarker development and validation — through our global network of specialty laboratories. We partner with government agencies, nongovernment organizations, as well as pharma and biotech organizations to change the shape of clinical development, and advance healthcare.
Cerba Research is part of Cerba HealthCare, a leading player in medical diagnosis.
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!
Download the flyer to learn more on CerbACT Asia’s capabilities.
Precision Medicine in Practice for Non-Small Cell Lung Cancer (NSCLC)
At the 16th Biomarkers UK Congress in November 2021, Rania Gaspo, PhD gave a talk on implementing precision medicine for Non-Small Cell Lung Cancer. How can you bring precision medicine into practice? What roles can Immunohistochemistry (IHC), Next-Generation Sequencing (NGS), and ctDNA play?
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.
- 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
Submit your information below to watch the webinar or to download the slide deck to receive our expert’s insights.
Case Study: How Cerba Research Helped Advance a Phase IIB Study in the Middle of a Pandemic and Brexit
How To Improve the Patients Experience in IO Clinical Trials – with the Gustave Roussy Institute
Webinar: The Advantages and Versatility of Flow Cytometry in Clinical Development
It is clear that the therapeutic future lies in biomarkers through the development of immunotherapies and companion diagnostics. Among the techniques of biomarker analysis, there is Flow Cytometry, which allows for precise analysis of liquid samples, but not only that.
Validation test development for specific biomarkers is a prerequisite for a successful application in translational research, preclinical and clinical phases. The advantages and disadvantages of this technique, the samples, the conditions of use: Cerba Research will open the doors of its worldwide laboratories for an hour. To answer all your questions about one of the leading technique of analysis for the development of innovative treatments, our experts will share their knowledge and experience.
Nithianandan Selliah, Ph.D. – Global Head of Flow Cytometry at Cerba Research
Nithianandan obtained his PhD in Immunology and started to work on HIV research. After more than 10 years of HIV research, he joined a biotech company to work on biomarker discovery for autoimmune diseases. His interest in Flow cytometry at the biotech led him to join global CRO to work on assay development and validation in Flow cytometry for global clinical trials. He joined Cerba Research to continue to work on his passion of Flow cytometry in clinical trials and takes on new challenges to build the best Flow cytometry service for the clients. He is working with exceptional scientific teams in the US and Belgium to bring on new assays for various therapeutic indications, including Immuno-oncology and autoimmune diseases.
Ishita Modi – Director, Scientific Customer Solutions at Cerba Research
A microbiologist by education, Ishita finished her studies at Gujarat University in India and moved on to starting her career in the United States. She has more than 15 years of experience in the clinical and diagnostic research industry. Her expertise is in building a strong foundation of clinical operations and clinical research with a commitment to meeting client’s scientific needs to help advance medicine. Ishita has worked at CRO/Central Lab as well as at some of the leading clinical diagnostic labs in the region. Her scientific expertise includes infectious diseases and genetics and gained extensive experience in microbiology, virology, and molecular biology. Ishita is a New York State certified Medical Technologist and also certified IRB (Institutional Review Board) professional. Her experience over the years has made her very strong in all aspects of clinical research and regulatory requirements. She has a passion for advancing science and making a difference in the future of healthcare.
Tech Transfer IFE Reflex Assay China
A Biotech Company in China required our scientific expertise for the Tech Transfer of IFE Reflex Assay on a clinical trial in the Oncology field (Relapsed or Refractory Multiple Myeloma). Cerba Research was not the Biotech’s central or specialty laboratory on the study but brought in for our expertise on the tech transfer.
Download the case study to read more.