Luminex Licensed Technologies Partner Spotlight: Intercientifica

Reliable prenatal testing and newborn screening based on xMAP® Technology

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xMAP Technology Enables Reliable Prenatal Testing and Newborn Screening

Prenatal testing and newborn screening programs are among the most effective tools to ensure that babies have the best chance to grow into healthy children. In Brazil, one company has lead the charge in this area for three decades: Intercientifica.

Founded in 1992 by Claudio Sampaio, Intercientifica runs all its tests on dried blood spot (DBS) samples. To produce a wealth of information from such low-volume samples, the company relies on xMAP® Technology for multiplexing. In 1999, it became one of the first Luminex Licensed Technologies Partners in Latin America. Now, the company has fully automated its xMAP workflow to ensure high-throughput testing with a fast turnaround time.

Intercientifica’s Start in Neonatal Screening

Sampaio never expected his career to lead to newborn screening. In the early 1990s, he was working as a salesman for the laboratory department of a Brazilian company when he had the chance to travel to the U.S. and take a tour of Sigma Aldrich: one of the company’s vendors. During that visit, he met with the leader of Sigma’s newborn screening business. “She told me that it would soon be mandatory to have newborn screening in Brazil, and that I should look into it,” Sampaio recalls.

That conversation altered the trajectory of his career—and the health of babies across Brazil.

“I took a deeper look at the market and was very excited,” Sampaio says. “It was a very small niche and nobody else was doing this in Brazil. I could see that it would be good for communities and good for children.”

He launched Intercientifica as a startup enterprise from his own home, receiving business and technical advice from newborn screening and laboratory testing experts around the world. Today, the company maintains a large, GMP-compliant manufacturing and testing facility in Brazil, while its subsidiary in the U.S., Intercientifica, creates its own kits for newborn screening and prenatal testing.

Multiplexed Newborn Screening Assays for Congenital Disorders Using xMAP Technology

Luminex Dot Pattern

Serendipity struck Sampaio again in 1999 when he met with the laboratory director for the New York State Department of Health. There, he was introduced to the multiplexing capabilities of xMAP Technology. “I was really excited about this, not only because of the ability to work with multiple markers, but also because of the sustainability,” he says. “With multiplexing, you can reduce the packaging, the water, and the space of your stock.” Additionally, xMAP-based assays require smaller volumes of reagents and antibodies, and the xMAP platform allows the use of just one DBS sample to perform the test. These two factors are beneficial to the economy of blood samples, a very important factor in the case of newborns.

While Sampaio was struck by the practical benefits of xMAP-based testing, he was also impressed by its utility, finding it easy to work with xMAP Technology. Today, the Intercientifica team has now developed several newborn screening and prenatal tests based on xMAP, which they run on a MAGPIX® system. While their first tests multiplexed two analytes, the number of analytes run simultaneously on their tests has steadily expanded over time.

Today, Intercientifica serves the newborn screening and prenatal testing markets in both Brazil and Mexico. Its multiplex product kits can detect common newborn screening targets such as congenital hypothyroidism (TSH and T4), congenital adrenal hyperplasia (17OH), cystic fibrosis (IRT), and infectious diseases.

Automating xMAP-Based Workflows for High-Throughput Neonatal Screening

With so much demand for Intercientifica’s services, Sampaio and his team decided to automate their xMAP workflow for a popular NeoMAP 4Plex newborn screening test. The outcome is the integration of the MAGPIX system with the Hamilton Microlab Nimbus — including the production of data-analysis software for details of each batch as percentile, controls, samples median, and floating cut-off — with capacity to deliver 3,000 results in less than four hours. There are now more than 20 systems installed across Central and South America.

The Intercientifica team worked with Hamilton to design and build the automated workflow it leverages. “Our engineers worked to make the connection between Hamilton automation and the Luminex MAGPIX system,” Sampaio says. The project took a year to complete, and now the company has a fully automated, easy-to-use process for newborn screening. Automation allowed the team to increase their testing capacity by about 50 percent and to reduce the materials used in the workflow.

Learn more about xMAP Technology or about the Luminex Licensed Technologies Partner program.

Discover xMAP Technology Luminex Partner Program

If you’re based in Latin America, please reach out to dmendoza@luminexcorp.com.

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At IMMUNOLOGY2023, Multiplex Technology was in the Spotlight

Multiplex immunoassays support vaccine development, immunology research, and other key applications within immunology

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IMMUNOLOGY2023: The Largest Conference of Immunology Professionals

The Luminex team was thrilled to attend IMMUNOLOGY2023, the annual meeting of the American Association of Immunologists. Held this year in Washington, D.C., the event is the largest conference dedicated to immunology research in the world, bringing together thousands of experts from academia, industry, and government to share the latest updates in immunology research, vaccine development, looming public health threats, and more.

Distinguished Speakers and Presentations at IMMUNOLOGY2023

The meeting is famous for its highly-regarded key opinion leaders and presentations, and the 2023 show did not disappoint. Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases, gave a lecture about what experts within the field can learn from the COVID-19 pandemic to better inform future pandemic preparedness efforts. Two other distinguished lectures, one from Douglas Green at St. Jude Children’s Research Hospital and the other from Leslie Berg at the University of Colorado, focused on T cells — it’s encouraging to see how much progress has been made in understanding the role of these cells and how we can utilize them to deliver better patient care.

Workshop Presentations: Harnessing Multiplexing for Immunology Studies

world vaccine week presenter

Immunology is a popular application for users of xMAP® Technology. Whether you’re measuring cytokine response or detecting the full range of antibodies relevant to a potential infection, having a bead-based multiplex assay to support your research provides an enormous advantage. Immunologists were among the earliest groups of scientists to see the value of stepping away from single-plex ELISAs to adopt our customizable, bead-based multiplex technology to generate more data while using minimal sample volumes.

Such was the focus for two workshop presentations at the conference. In one, Anthony Saporita from MilliporeSigma spoke about xMAP Technology and how multiplexing kits allow for lot-to-lot consistency, sensitivity, flexibility, and reproducible sample measurement. He also highlighted the benefits of using extremely sensitive assays for the detection of low-abundance cytokines. In a separate talk, Luminex’s own Joanna Dragich gave a presentation on the power of xMAP multiplexing technology for vaccine development applications, from drug product characterization to serotype monitoring, lot-release testing, and post-market surveillance. She also spoke about how scientists may best approach designing custom multiplex assays for vaccine development.

Looking Ahead: IMMUNOLOGY2024 in Chicago, IL

If you attended IMMUNOLOGY2023, we hope you found it as illuminating as we did. We’re already looking forward to next year’s event in Chicago, IL!

Curious how xMAP Technology advances other immunology studies?

Check out our Immunology Resource Hub >>

For Research Use Only. Not for use in diagnostic procedures.

Top Six Challenges in Biomarker Research and Analysis

Here are some helpful tips for the top six challenges of your biomarker research and analysis, as well as how xMAP’s multiplexing technology can help you ensure swift, accurate results and accomplish your goals.

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1) Variability in Biomarker Results

Variability in biomarker test results can present complications for health scientists across research areas. Because biomarkers are often measured from biological samples, such as blood, urine, or tissue. These samples are susceptible to various biological and environmental factors, which may lead to variability in results. This variability can make it difficult to identify true biomarker signals and to replicate findings.

  • Luminex xMAP® Technology addresses this issue by allowing for the simultaneous measurement of multiple biomarkers in a single sample. Utilizing a single sample reduces variability in biomarker results—which often comes from using multiple samples and assays—to occur. Further, Luminex xMAP Technology is highly sensitive, enables robust detection with small sample sizes, and can be used along with automation, which ensures reproducibility and accuracy of results. For these reasons, using Luminex xMAP Technology is an effective way to reduce variability and achieve consistent and reliable biomarker measurements.

2) No Standardized Protocol for Biomarker Research

There is currently no standardized protocol for biomarker research, including sampling methods, storage conditions, and analytical techniques. This lack of standardization can lead to differences in results between studies and make it difficult to compare findings.

  • Using Luminex xMAP Technology can address the lack of standardization in biomarker research by providing a standardized platform for multiplex analysis of biomarkers. This technology allows for the simultaneous analysis of multiple biomarkers in a single sample, reducing the amount of sample needed and increasing efficiency. Luminex, along with our four research partners, also has standardized protocols for sample preparation, storage, and analysis, ensuring consistency across different studies and improving the reliability of results. By using this technology, researchers can compare results across multiple studies and evaluate the effectiveness of different interventions.

3) Disease Biology is Complex

The underlying biology of many diseases is intricate and multifaceted, making it difficult to identify a single biomarker or set of biomarkers able to accurately reflect disease status

  • xMAP multiplexing technology offers more comprehensive insight into potential biomarkers, allowing researchers to draw a more complete picture of complex biological mechanisms or disease states.
  • Luminex xMAP Technology currently has one of the largest selections of analytes through our network of partners, including leading life science companies such as Bio-Rad, Millipore Sigma, Bio-Techne, Thermo Fisher, and others.

4) Sample Size and Data Analysis

Biomarker research often requires large sample sizes and extensive data analysis, which can be costly and time-consuming. Additionally, finding reliable and accurate biomarkers requires a great investment of time and money from pharmaceutical and biotech companies.

  • xMAP multiplexing technology allows researchers to simultaneously detect multiple biomarkers in a single sample, thereby reducing the time required to analyze each biomarker individually. This increased throughput can lead to faster and more efficient biomarker studies. The ability to detect multiple biomarkers in a single sample also reduces the cost of reagents and sample preparation and the time and labor associated with running multiple assays separately.

5) Protein Biomarker Sensitivity and Specificity

Measurement of protein biomarkers may not be sensitive or specific enough for accurate detection or prediction of disease-related outcomes.

  • Luminex xMAP Technology uses microsphere-based assays that can detect multiple analytes simultaneously in a single sample, allowing for more comprehensive biomarker profiling. This technology also employs fluorescently encoded microspheres, which can be distinguished based on their unique spectral signatures, enabling the detection of multiple biomarkers with high sensitivity and specificity. Luminex xMAP Technology also offers the flexibility to customize panels based on specific disease or research needs, providing a more tailored approach to biomarker detection and profiling. Overall, the use of Luminex xMAP Technology can improve the accuracy and precision of biomarker detection, leading to improved disease diagnosis and prediction of outcomes.

6) Heterogenous Biological Samples

Biological samples are often heterogeneous and include different cell types and physiological conditions that can affect the accuracy of protein biomarker research.

  • Luminex xMAP Technology allows for the analysis of multiple proteins simultaneously in a single sample, using fluorescently labeled microspheres specific to each protein. This allows for the detection of protein biomarkers in a heterogeneous sample and can identify specific changes in protein expression among different cell types and physiological conditions. Additionally, Luminex xMAP Technology offers high sensitivity and improved accuracy in identifying low-abundance proteins. Overall, using Luminex xMAP Technology can provide a more comprehensive and accurate assessment of protein biomarkers in complex biological samples.

Learn more about how to get started with xMAP Technology, here!

Discover xMAP Technology

For Research Use Only. Not for use in diagnostic procedures.

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With Record Attendance, AACR 2023 Spotlights Diagnostics

Protein and molecular-based research and diagnostics, including multiplexed bead-based assays, were front and center at the 2023 cancer research conference

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Every year, thousands of the world’s leading cancer researchers convene to share the latest scientific advances and clinical research discoveries at the annual meeting of the American Association for Cancer Research. The Luminex team was excited to attend another insightful AACR annual meeting at the Orange County Convention Center in Orlando, Fla., where more attendees than ever gathered for the event.

The era of genomics and rapid progress in cancer research

After decades of slow but steady progress in understanding the underlying mechanisms of cancer, the era of genomics has transformed the pace of cancer research. We love attending the annual AACR meeting because it provides a great snapshot of the most exciting recent developments in the genomic advancements in cancer research, as well as a reminder of just how quickly these advances are happening. From large-scale genomics studies to deep dives into the interplay of a tumor and surrounding environment, the results reported at AACR meetings are likely to drive improvements in how cancer is treated in the future. This year, a track about multiomics in diagnosis and care management was especially popular, and sessions of particular interest to us include those on the biology of early cancers, precision prevention, and early cancer detection.

Advancements in molecular diagnostics: spotlight on xMAP® multiplexing technology

In addition, we were eager to see several posters highlighting the use of xMAP® Technology applications in cancer research. One from Hideki Furuya, PhD, a scientist at Cedars-Sinai Medical Center in Los Angeles, illustrated how Furuya and his team used Bio-Techne assays based on xMAP Technology to detect, monitor, and predict urothelial carcinomas. It was an impressive demonstration of how multiplexing technology can help scientists achieve more than they could with conventional single-plex tests.

Another poster from Cuipeng Qiu and colleagues at the University of Texas at El Paso showcased how scientists developed a panel of anti-tumor associated autoantibodies for detecting prostate cancer. Furthermore, two additional posters were presented by scientists at Millipore Sigma: one featuring immune checkpoint biomarkers in mouse tumor models, and another about a 48-plex cytokine assay for colorectal cancer.

Introducing the upgraded xMAP INTELLIFLEX® System

Another AACR 2023 conference highlight occurred at our booth in the exhibit hall, where it was an honor to share the newest capabilities of our xMAP INTELLIFLEX System. With a recent software update, the system is now more flexible, secure, and easy to use, as it incorporates optional modules to enable integration in an automated workflow, electronic records compliance for 21 CFR Part 11 and EU Annex 11, as well as improvements to the user experience.

These updates make the xMAP INTELLIFLEX System a great fit for research that must comply with regulatory oversight and cybersecurity requirements, such as many cancer studies conducted by pharmaceutical and biotech companies. We’ll be rolling out the new software gradually throughout this year.

We hope you had as much fun at AACR as we did. We’re already looking forward to next year’s conference in San Diego!

Keep up with the latest from Luminex year-round and find out which events we’ll be attending by subscribing to the xMAP Resource Round-Up email newsletter—your source for the latest research, resources, and updates for all things xMAP.

Sign up now >>

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Partner Spotlight: ImmunoProfile®

Understanding one’s disease protection begins with confidently knowing one’s antibody status

Co-Authored by Jessica Schneider

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Inspired by the inventive ways our Luminex Partners benefit healthcare, we spotlight one of our newest Partners, ImmunoProfile®. Founded by two veterans in the medical devices industry, ImmunoProfile® offers an IgG serology test panel to easily learn your antibody protection level to each of 11 different infectious diseases. The pathogens they test antibodies for include Hepatitis A, Hepatitis B, H. Influenza B, Measles, Mumps, Rubella, Tetanus, Diphtheria, Pertussis, Varicella Zoster/Chicken Pox, and Polio. One of the advantages of this company’s testing service is the convenience it offers customers through online ordering and an at-home specimen collection kit that utilizes a single finger-prick blood sample. Through the testing of dried blood spots, ImmunoProfile can then evaluate antibody levels of each of the 11 different infectious diseases, all of which are vaccine preventable according to the CDC.

Reliable Results with ImmunoProfile’s Technology

ImmunoProfile’s goal is to “empower people everywhere to protect themselves from infectious diseases,” achieving this by placing the power into the hands of private individuals through an easily accessible affordable system with the convenience of at-home testing. Using the FDA-cleared Luminex technology, the antibody test results are evaluated against World Health Organization (WHO) established standards. Rather than having to travel to a medical facility, customers can obtain their highly accurate and affordable results through a secure and private online portal after they’ve provided their at-home finger-prick blood specimen and mailed it in the pre-addressed UPS envelope to the company’s CLIA/CAP-certified lab. The test is available in all 50 states and Washington, D.C. and HSA/FSA payments are accepted.

The Power of xMAP® Technology in Multiplexing Assays

As part of a growing number of Luminex Partners offering testing services to the public, ImmunoProfile seeks to advance healthcare by applying its business model to a science that is both accessible and affordable. And what is the foundation behind this science? xMAP® Technology. One of the many advantages of Luminex’s multiplexing platform is that it allows users to simultaneously detect up to 500 targets in a single well, providing customized flexibility for both proteomic and genomic assays.

Advancing Healthcare with Innovative Testing Solutions

Partners like ImmunoProfile demonstrate how xMAP Technology is a reliable and well-established multiplexing technology that has performed successfully throughout many markets, including RUO, clinical diagnostics, non-diagnostic at-home sample collection, and others. As with ImmunoProfile, understanding one’s disease protection level begins with confidently knowing one’s antibody status. Be sure to visit their website to learn more about the services performed at ImmunoProfile.

Furthermore, if you are interested in learning more about xMAP Technology for your own testing needs please visit our website and request to speak with our sales team to learn more about our multiplexing platform and benefits of becoming a partner.

Become a Luminex Partner Today!

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World Vaccine Congress: The Growing Need for High-Quality Immune Profiling

Recent innovation in vaccine development spotlights the demand for robust technology to measure cytokines, immunoglobulins, and more

The Luminex team was pleased to attend this year’s World Vaccine Congress, which took place in April in Washington, DC. With so much innovation in vaccine development and commercialization occurring globally, it was exciting to learn about the latest advancements from some of the field’s leaders.

The Growing Need for Reliable Immune Profiling Technologies in Vaccine Development

The event’s highlights spanned the vaccine development spectrum, from basic research to manufacturing. We heard from government and regulatory experts, pharmaceutical executives, and scientists from leading vaccine research institutions. Along with thousands of attendees, we learned about new findings and progress related to the mRNA vaccine durability research, rational vaccine design, supply and logistics planning, and immune profiling.

world vaccine week presenter

xMAP® Technology: Providing Comprehensive Immune Profiling Insights for Vaccine Development

We were also honored to have our own Dominic Andrada provide a presentation during the meeting’s Immune Profiling session. In his talk, titled “Updated Strategies for Immune Profiling in Vaccine Development with xMAP® Technology,” he explained that immune profiling is a popular application for xMAP Technology because its unique multiplexing capacity allows for truly comprehensive and quantitative views of the many components involved in immune response. This is particularly relevant to the vaccine development community, where advances in mRNA vaccines, cancer vaccines, recombinant antigens, and new adjuvants, among other factors, have been driving demand for immune profiling data.

With so many new avenues for vaccine development, it’s important to have a robust, reliable technology for these immune profiling experiments. As the global community moves beyond its three-year focus on COVID-19 vaccines, there will be a strong need to understand cellular immune response in vaccine candidates.

Applications of xMAP Technology in Vaccine Development

For many xMAP users, cytokine measurement in vaccine response is a key area of interest, and this is an especially good fit for our xMAP INTELLIFLEX® System, which has an optional dual-reporter channel to measure closely related analytes. Relevant real-world examples include an analysis of IgG and IgM antibody responses to SARS-CoV-2 antigens and the use of xMAP Technology to develop a cost-effective COVID-19 vaccine, known as Corbevax at Baylor’s Center for Vaccine Development.

Other relevant applications of our multiplexing technology include the identification of secreted proteins, mechanism of action studies, pathogen detection, genotyping, the measurement of protein-protein interactions, and more.

Request a copy of the immune profiling presentation or learn more about the use of xMAP Technology in vaccine development.

Request the Immune Profiling Presentation

xMAP Technology In Vaccine Development

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xMAP® Connect: Detecting Early Risk of Stroke with a Multiplex Immunoassay

Scientists are using xMAP® Technology to develop a new assay for vascular brain injury

Dr. Jason Hinman

Attendees of our latest xMAP® Connect event learned about the impact of multiplex testing for patients with vascular brain injury from Jason Hinman: Associate Professor at the University of California, Los Angeles and President of Sage Cerebrovascular Diagnostics.

Dr. Hinman and his team developed a new assay for vascular brain injury using xMAP® Technology, making it possible to detect early risk of stroke with a multiplex immunoassay.

Detecting Early Risk of Stroke with a Multiplex Immunoassay

Hinman and his team aimed to develop a blood-based test able to detect key indicators of vascular brain injuries that increase the risk of stroke and dementia. Stroke, for instance, is a leading cause of disability and death around the world, Hinman noted. A more effective test to detect “silent” brain injuries would make it possible to improve treatment for those most in need.

A Multiplex Immunoassay for Vascular brain injury

At the beginning of this effort, Hinman was already acquainted with xMAP Technology, which he had previously used to measure cytokine activity associated with inflammatory signaling in the brain. His familiarity with xMAP Technology inspired him to continue utilizing the bead-based platform for his novel cerebrovascular test, which would aim to diagnose the presence of severe, silent brain injuries. The new assay, which was evaluated on patients at the Ronald Reagan UCLA Medical Center Emergency Room included six biomarkers and generated a composite score of 94% specificity using blood or serum samples.

“The Luminex xMAP Technology is really optimal for the challenge we are facing because it allows us to build a multiplex assay now that we can continue to augment in the future and it allows us to quickly scale,” Hinman explained.

Minimizing Cross-Reactivity in the Cerebrovascular Test

In his presentation, Hinman also spoke about the challenges of assay development and commercialization. His team worked with Luminex partner, Bio-Techne, to obtain robust antibodies for their desired targets. They also spent quite a bit of time minimizing cross-reactivity, ensuring strong performance across Luminex devices, and optimizing additional assay details.

Now, the assay will be tested in NIH-funded studies of up to 14,000 patients. Hinman’s team plans to launch it initially as a laboratory-developed test.

Watch the Presentation Now On-Demand

Watch the on-demand presentation now by visiting our xMAP Connect Virtual Conference Hub on Labroots. While you’re there, be sure to check out more presentations from the xMAP Connect event in La Jolla to learn more about the latest advancements in multiplexing technology.

We hope to see you at the next xMAP® Connect event in Atlanta, GA this November to learn about the latest advancements in multiplexing technology.

Watch Now >>

Read highlights from several more presentations from xMAP Connect in these related blogs:

Video Demonstration: Monitoring Immune Response with a Dual-Reporter System

New JoVE video shows how to monitor immune response associated with COVID-19

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Early in the COVID-19 pandemic, researchers at Rush University Medical Center in Chicago developed and validated a multiplex serological assay to test for antibodies targeting four different antigens of the SARS-CoV-2 virus. The assay was based on xMAP® Technology and can track exposure to the virus based on antibodies targeting its spike, nucleocapsid, membrane, or envelope proteins.

Now, the same team has created a helpful video tutorial for anyone interested in monitoring the immune response to a COVID-19 vaccine or SARS-CoV-2 infection. The team’s method demonstrates how to measure dynamic antibody titer changes in IgA, IgM, or IgG. A multiplex reader with dual-reporter capacity, such as the xMAP INTELLIFLEX, allows users to check two of the three immunoglobulins at one time.

Published by the online video journal JoVE, the step-by-step protocol comes from lead authors Cristina Fhied, Imad Tarhoni, and senior author Jeffrey Borgia. “This approach allows us to evaluate multiple epitopes on the same analyte,” Borgia explains in the video.

In the demonstration, Tarhoni performs and describes each step in the workflow. He shows how different time frames can be tested — he used increments of 30, 60, and 120 minutes — to compare results and determine which is best suited to achieve the desired results.

“This method has important implications for monitoring response to vaccines in immunocompromised individuals,” Borgia concludes. “It will permit us to determine if these patients are truly getting protected by these vaccinations.”

To learn more about the dual-reporter capabilities of our new xMAP INTELLIFLEX® System, check out this overview.

Discover the Possibilities >>

For Research Use Only. Not for use in diagnostic procedures.

xMAP Technology at PepTalk 2023

PepTalk 2023: An Overview

Last month, scientists working in drug discovery and biologics development were treated to an informative and insightful PepTalk 2023 conference in San Diego, CA from January 16-20. More than 850 participants from top global pharma, biotech, academic, and governmental institutions convened to learn about the latest scientific advancements in cutting-edge biologic therapies.

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Specific areas of focus included Antibody Discovery & Engineering, Bispecific Antibody Development, Characterization of Biotherapeutics & Vaccines, Cell & Gene Therapy, Biotherapeutic Expression & Production, and Process Technology & Innovation.

The Pursuit of Better Outcomes with New Biologic Therapies

While monoclonal antibody (mAb) therapeutics comprise the majority of new biologics, new modalities are being developed to better treat patients and improve disease outcomes. These new therapeutic modalities may specifically target solid tumors, decrease off-target effects resulting in lower toxicity, and recruit the body’s immune system to express proteins that fight chronic disease.

Many of these new biologic therapies are designed and built as individual components before they are assembled to form active drug products, unlike small molecular weight (SMW) drugs or a specific mAb. This provides added therapeutic utility; for biologics such as antibody drug conjugates (ADCs), bispecific antibodies, mRNA vaccines, and cell and gene therapies, it also increases the complexity of manufacturing. The added complexity often requires multiple bioanalytical techniques for measuring toxicity and intended therapeutic effects.

While Luminex assays are well known in drug discovery, several sessions discussed xMAP® Technology also being used in process development and manufacturing stages for mRNA vaccines. xMAP’s ability to measure hundreds of proteins or genomic targets in a sample provides unmatched comprehensive analysis on a single platform. Custom built Luminex assays—particularly those that measure specific impurities and residual host-cell proteins—also provide greater utility for reliably assessing the safety of these new biologics.

Updated Regulatory Guidelines

Another hot topic at the conference was the response from regulatory agencies, such as the FDA and EMA, to these novel biologics therapies. These regulatory agencies are updating guidance documents in both the USA and Europe, and are working with industry sponsors to clarify parameters for the proper manufacture, quality characterization, and safety assessment of these new therapies.

Learn more about Luminex’s revolutionary xMAP Technology for multiplex immunoassays, and explore today how Luminex technology can advance your lab work to the next level.

Learn More >>

For Research Use Only. Not for use in diagnostic procedures.

Clinical and Laboratory Standards Institute Honors Dr. Sherry Dunbar

Award recognizes substantial time and effort in supporting clinical lab standards and guidelines

As a dedicated participant in the clinical lab community, we are honored to have a member of our team recognized by the prestigious Clinical and Laboratory Standards Institute (CLSI). Congratulations to Dr. Sherry Dunbar, Senior Director of Scientific Affairs here at Luminex, for winning CLSI’s Excellence in Standards Development Award!

This annual award is bestowed upon a volunteer who goes above and beyond in the development, implementation, or promotion of laboratory standards and guidelines. The award is open to any CLSI member, and winners are chosen by the institute’s Awards Committee and executive leadership.

— CLSI

“These awards celebrate the achievements of CLSI volunteers and organizational members who are committed to CLSI’s mission and have helped improve the quality of medical care worldwide.”

Here’s how CLSI described Sherry’s commitment to clinical laboratory standards:

“Dr. Dunbar has served on many CLSI document development committees throughout the years in the roles of Vice-Chairholder and member and has also participated on a task force with CLSI leadership that resulted in an improved and more streamlined document development process. Dr. Dunbar has been a member of the Expert Panel on Molecular Methods since 2014 and has served as its Vice-Chairholder since 2020. She has also participated in webinars supporting the education of laboratorians based on several of these guidelines.”

Sherry joined Luminex in 1999 after serving as director of the Virus Reference Laboratory in Houston. Her passion for serving the clinical laboratory community has been clear to all, and she has always provided us with the voice of the customer as we develop new technology platforms and in vitro diagnostic tests and research assays for clinical labs.

Luminex President Angelo Rago summed up our response to this great news: “Sherry exemplifies our commitment to advancing healthcare through high-quality laboratory medicine. On behalf of the entire Luminex team, I would like to congratulate her for this tremendous and well-deserved accomplishment.”