In recent years, immunology has gained prominence in the life science field, propelled by the literal explosion of cell and gene therapies and novel immunotherapies that train immune cells either to attack various cancers or to be tolerant in autoimmunity. Coupled with a deeper understanding of the immune system’s multifaceted role in immune-related diseases, immune profiling has become a cornerstone in the drug development process.
Immune Profiling: More Than Just A Trend
Imagine immune profiling as a detective piecing together clues at a crime scene. The clues? An individual’s unique immune status, pathophysiology of the disease and presumed or known mechanism of action of the treatment. By examining cellular or humoral evidence, we can assemble a detailed and comprehensive “fingerprint” of each person’s specific immune system and understand their response to a therapy or even predict adverse reactions. This profiling forms a vital part of the drug development process, offering insights into, the functionality of specific cell types, including but not limited to cytotoxicity, proliferation, as well as cytokine production. To fully comprehend these complex immune responses, we rely on multimodal multiplexed analyses.
Our company is excited that immunoprofiling is turning visionary solutions into reality for drug developers. We want people to understand that the recent progress that we’ve seen in the field is just the beginning. It holds potential to strongly impact the way that both clinical trials and bioanalysis are conducted. We view its evolution as a three-stage process which pushes medicine into a new era:
- Access to advanced techniques: A decade ago, many of the techniques we use today were unavailable. Now, armed with highly sophisticated instruments and improved standardization, scientists can profile immune cells and soluble mediators from global clinical sites, unveiling patterns within massive datasets that mirror the diversity and intricacies of immune responses.
- Deeper understanding of the immune system: These improved techniques allow us to expand our understanding of how the immune system interacts with not just infectious diseases, autoimmune disorders and tumors, but also conditions like neurodegenerative diseases.
- Engineering and controlling the immune system: Armed with both expanded tools and knowledge, drug developers are now learning how to better engineer immune cells and fine-tune their control of the immune system to address multiple health issues effectively.
The Advanced Toolbox Driving Immune Cell Profiling
A toolbox of diverse high parameter technologies has made it possible to delve deep into the world of immune cells. Each tool is designed to answer specific questions.
- Flow Cytometry: identifies and characterizes immune cells and their activity. It asks – “What are these immune cells?” and “What state are these cells and their receptors in?” as well as “How do these cells react to a stimulus?”
- ELISpot and Isoplexis: focuses on the cells’ products. They wonder – “What are these cells producing in response to a stimulus?”
- Protein Analysis Technologies: provide information about proteins that are predominantly produced by the immune system. They inquire – “What have these cells done in the past?” or “What environment are these cells currently in?”
By using these complementary technologies together, we can gain a more comprehensive understanding of an individual’s immune composition and state. Flow cytometry is often the go-to technology for immunophenotyping due to its ability to measure a wide range of immunological parameters. This is largely due to the advancements in flow cytometers, antibody production and labeling techniques, providing virtually limitless flexibility in terms of antibody targets and exceptional cell-to-cell resolution. As a result, our highly trained scientists can now concurrently measure over 20 cell surface markers with conventional flow cytometers, like the BD Fortessa and NovoCyte Quanteon platforms in Lyon, Milan and Philadelphia. Additionally, Philadelphia’s Cytek model enables potential measurement of 40+ markers via full spectrum cytometry without compromising data resolution.
Customized Support to Address Challenges in Immune Cell Profiling
Given the intricacies involved in immunoprofiling, having a trusted partner who can provide discipline specific guidance and support is critical. Panel design, sample collection, and reagent management are just three of the many areas where critical decisions need to be made to enable smooth project execution.
We recognize that translational research directors and bioanalytical coordinators experience contradictory pressures to deliver extremely precise data as quickly as possible. To address both goals, we aim for a balance by offering both customized panels and ready-to-use options. Our experience in designing and titrating hundreds of panels for dozens of indications allows us to speed up or bypass some of the method development work, reducing project time and maximizing research budget impact even for custom panels. We have also leveraged more than 300 years of collective flow cytometry experience to pre-validate custom panels for the most commonly used cell subsets, streamlining the path to operational efficiency and again maximizing return on research budgets. We continue to partner with vendors, sponsors, and universities on a global basis to evaluate and implement cutting edge technologies as soon as they are available to open new avenues for pre-clinical and clinical research.
Our experience is also helpful for advising on or helping to develop the pre-analytical treatment of samples. We adhere to a timeless and uncompromising principle: “Garbage in, garbage out”, meticulous execution of all pre-analytical steps, from maintaining sample integrity to harmonizing sample preparation across multi-center studies, is absolutely fundamental. Quality is paramount to ensure accurate and reliable results. Thus, samples need to be either stabilized, frozen, or processed at the right time and in the right way that can be difficult to accomplish without training at a busy clinical site. For a deeper dive into sample preparation standardization, our previous KCAS blog serves as an informative guide.
In addition, we use a robust process to ensure that reagents, selected for a project, are robust enough to provide a secure foundation for decision-making. We have a strict quality assurance process that screens vendors so that only the most stable and reliable tools are evaluated when selecting reagents, fluorochromes, standardization tools, and quality control material. Critical reagents are monitored and compared across lots as needed for long-term clinical studies, and the entire logistical workflow is considered and coordinated at the beginning of the study to create a seamless process. Together, logistical and scientific challenges can be overcome in a way that meets our rigorous GLP or GCLP standards.
Immunoprofiling is emerging as a leading industry trend. As a response of this shift and the rapid technological and therapeutic advancements, we’re strategically investing in people, state-of-the-art technologies, and expanding facilities. Our Philadelphia site is a brand new 26,000 square foot facility that just brought in the most advanced instruments. The modern Lyon site facility is equally equipped with cutting edge technology affirming our position as a premier service provider. Our team’s experience and foresight ensure our immune cell profiling services remain precise, reliable, and accurate – a hallmark of our commitment to excellence.