SIAT® Immunogenicity Assessment Services

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Relying on the outstanding academic group and profound expertise, Creative Biolabs has successfully established the proprietary Sensitive Immunogenicity Assessment Technology® (SIAT®) system that can be utilized to evaluate the immunogenicity potential for a broad range of biotherapeutic drug candidates. </p> <h2 class="h2_tit page_tab_margin" id="tab1"> Background </h2> <p> Biotherapeutic drugs, including protein, enzyme, antibody, antibody-drug conjugate (ADC), are of significant value in the treatment of various diseases. Compared to small molecule drugs, the advantages of biotherapeutic drugs are mainly manifested by prolonged half-life, high target specificity, and low intrinsic toxicity. However, the use of biotherapeutic drugs can lead to unwanted immune responses such as the generation of anti-drug antibody (ADA) in patients, depending on multiple patient-related and product-related factors. The immune responses to biotherapeutic drugs decrease the efficacy of the drugs due to faster clearance of the drugs as antigens. In addition, unwanted immune system activation raises concerns of patient safety for issues such as rapid and enormous cytokine release. Therefore, immunogenicity risk management of biotherapeutic drugs and biosimilar biologics is critical for successful development. On the other hand, due to the enormous investment and cost in the whole process of developing a biotherapeutic drug candidate, it is worthwhile and necessary to assess the immunogenicity at the early stage of the drug discovery process. Above all, immunogenicity assessment is one of the major requirements for IND application. </p> <p class="ServiceShowPic"> <img loading="lazy" height="261" src="static/img/SIAT-Immunogenicity-System-1.jpg" width="500" alt="Example roadmap for immunogenicity prediction." /> Fig.1 Example roadmap for immunogenicity prediction. (Jawa <em>et al</em>., 2013) </p> <h2 class="h2_tit page_tab_margin" id="tab2"> Featured Services of SIAT® System </h2> <ul class="ullist"> <li> <strong><em>In Silico</em> Immunogenicity Assessment</strong> </li> <p> SIAT® <em>in silico</em> immunogenicity assessment is able to analyze and predict the potential immunogenicity of biotherapeutic drug candidates. The protein sequences are analyzed by modern bioinformatics combined with experimental human HLA binding data to estimate the binding affinity of the peptide to HLA, which can predict the potential of the peptide for T cell activation. Our SIAT® <em>in silico</em> immunogenicity assessment service is the best fit for the early discovery and exploring stage. </p> <li> <a href="/siat-sup-class-ii-hla-binding-assay.html"><strong><em>In Vitro </em>Class II HLA Binding Assay</strong></a> </li> <p> Although the <em>in silico</em> models can predict the binding affinity of peptides in biotherapeutic drug candidates to class II HLA alleles, the accuracy of these prediction algorithms is not always in accordance with physical binding data. Therefore, after having defined the epitopes of interest <em>in silico</em>, further <em>in vitro</em> assays are needed to validate these predictions, among which class II HLA/MHC binding assay is the most widely used. </p> <li> <a href="/ex-vivo-Immunogenicity-Assessment.html"><strong><em>Ex Vivo</em> Immunogenicity Assessment</strong></a> </li> <p> Creative Biolabs offers SIAT® <em>ex vivo</em> immunogenicity assessment service that utilizes human peripheral blood mononuclear cells (PBMCs) to provide an immune response model. This model closely resembles the immune response <em>in vivo</em>. The responses of T cells or B cells to candidate biotherapeutic drugs are evaluated. Multiple techniques such as ELISPOT, ELISA, and Flow Cytometry are used according to different needs. </p> <li> <strong><em>In Vivo</em> Immunogenicity Assessment</strong> </li> <p> SIAT® <em>in vivo</em> immunogenicity assessment employs the standardized immunogenicity assessment protocols with a personalized approaching strategy. HLA transgenic mice or humanized mouse models are available at our facility and collaboration partners. These mouse models provide functional and reliable elements of human immune systems without putting patients at risk. </p> <li> <a href="/Anti-drug-Antibodies-ADA-Assays.html"><strong>Anti-drug antibody (ADA) Assay</strong></a> </li> <p> Anti-drug antibody (ADA) has been observed in many preclinical and clinical studies, resulting in significant impacts in efficacy, toxicology, and pharmacokinetics of biotherapeutic drugs. The detection and confirmation of ADAs, as well as neutralizing antibodies (NAbs), comprise a fundamental part of immunogenicity assessment. Following current FDA and EMEA guidelines and AAPS white papers, SIAT® system can detect ADAs by using a variety of leading instrumentation platforms, such as ELISA/RIA, surface plasmon resonance (SPR) and electrochemiluminescence (ECL). </p> <li> <a href="/immunogenicity-assay-for-preclinical-study.html"><strong>Immunogenicity Assay for Preclinical Study </strong></a> </li> <p> The immunogenicity data in preclinical studies is essential to the safety and efficacy evaluation of a protein therapeutic. Currently, we have established a variety of immune modeling assays to determine the immunogenicity in animal models, and test their roles in cell activation. In general, the T cell immune responses to biopharmaceuticals have been quantified for real-time kinetic measurements. Meanwhile, antigen processing and MHC affinity of T cells have been also analyzed in humanized mouse models. </p> <li> <a href="/in-vitro-human-systems.html"><strong><em>In Vitro</em> Human Systems </strong></a> </li> <p> The<em> in vitro</em> human system has been considered as the most suitable model for detecting the immunogenicity of potential biotherapeutic molecules in preclinical studies. Creative Biolabs has generated an <em>in vitro</em> human cell-based assay based on two-dimensional (2D) cell culture and three-dimensional (3D) cell culture technologies. Human cell-based assays play an important role in stimulating the cellular microenvironment to reveal <em>in vivo</em> cell mechanisms, including cell differentiation, cell growth, and cell activation. As a consequence, these models are attractive systems for evaluating immunogenicity <em>in vitro</em>. </p> <li> <a href="/immunogenicity-analysis-of-immune-related-diseases.html"><strong>Immunogenicity Analysis of Immune-Related Diseases </strong></a> </li> <p> Up to now, various types of biopharmaceuticals, especially for antibodies and therapeutic protein, have proven the efficacy in specific disease treatments. However, the immunogenicity of biopharmaceuticals still needs to be evaluated in different disease models, such as tumors, autoimmune diseases, infectious diseases. Creative Biolabs offers a series of immunogenicity analyses targeting specific disease types. We can help client to test the immunogenicity in disease models, and to further provide no immunogenicity version of biopharmaceuticals for clinical use. </p> <li> <a href="/immunogenicity-risk-assessment.html"> <strong>Immunogenicity Risk Assessment </strong></a> </li> <p> At Creative Biolabs, we bring novel services to evaluate immunogenicity risk and provide a panel of assays to identify the risk factors and actual causes for immunogenicity in different kinds of candidate therapeutic drugs. Our platform consists of <em>in silico</em> and <em>in vitro</em> strategies to analyze the interactions among immune cells, immunogenicity risk, and lead targets. Pilot studies conducted by our labs have shown that physicochemical structural properties, immunological tolerance, administration route are key factors for causing unnecessary immunogenicity in pre-clinical and clinical studies. </p> </ul> <p class="ServiceShowPic"> <img loading="lazy" height="193" src="static/img/SIAT-Immunogenicity-System-2.jpg" width="700" alt="SIAT Immunogenicity System." /> Fig.2 SIAT® Immunogenicity System. </p> <p> <strong>Creative Biolabs</strong> is one of the leading service providers for biotherapeutic drug development. Our scientists have gained extensive experience through years of cooperation with customers across the world. Our comprehensive SIAT® system offers <em>in silico</em>, <em>in vitro</em>, <em>ex vivo</em>, <em>in vivo</em> immunogenicity assessment and ADA assay services. We also provide de-immunization service if high immunogenicity potential is identified. All these services will assist customers in candidate selection and optimization in different phases of new biotherapeutic drug development. <a class="inquiry-button">Contact us</a> to discuss your project and experience the great value of our services. </p> <h2 class="h2_tit page_tab_margin" id="tab3"> Published Data </h2> <ul class="ullist"> <li> <strong>Immunogenicity Assessment of Engineered Therapeutic Antibodies by Assessing IL-2 Secretion from CD4+ T Cells</strong> </li> </ul> <p class="show-center"> <img loading="lazy" src="static/img/1-2-8-1-siat-immunogenicity-assessment-services-3.jpg" width="450" height="247" alt="" />Fig. 3 Induction of IL-2-secreting CD4+ T cells by therapeutic antibodies on Day 3. (Yoshiyuki Arata, 2023) </p> <p> The study presented in the article evaluates the immunogenicity of engineered therapeutic antibodies by assessing interleukin-2 (IL-2) secretion from CD4+ T cells. This rapid in vitro method can predict the potential for anti-drug antibody (ADA) formation, a critical factor in the efficacy and safety of biotherapeutics. The results show that the assay effectively mirrors clinical outcomes regarding ADA incidence, as demonstrated by the response rates of antibodies known for their immunogenic profiles. Immunogenicity assessment in this study was crucial for determining how engineered antibodies might stimulate immune responses, particularly through the activation of CD4+ T cells that secrete IL-2, an early indicator of immunogenic potential. This assay allows for a quick and predictive measure of how a therapeutic antibody might interact with the immune system before extensive clinical trials. </p> <div class="reference"> <strong>References</strong> <ol class="ollist decimal"> <li> Jawa, V.; <em>et al</em>. T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation. <em>Clin Immunol</em>. 2013, 149(3): 534-55. </li> <li> Arata, Yoshiyuki, et al. "Rapid in vitro assessment of the immunogenicity potential of engineered antibody therapeutics through detection of CD4+ T cell interleukin-2 secretion." <em>MAbs</em>. Vol. 15. No. 1. Taylor & Francis, 2023. </li> </ol> </div> <script type="text/javascript"> window.addEventListener('load',function(){ faqlist(4); }); </script> <h2 class="h2_tit page_tab_margin" id="tab4"> FAQ </h2> <ol class="ollist faqlist"> <li> <span class="sFAQTit">What is immunogenicity and why is it important to assess in biotherapeutic drug candidates?</span> <p> Immunogenicity refers to the ability of a substance, such as a biotherapeutic drug, to provoke an immune response in the body. This assessment is crucial for biotherapeutic candidates because an immune response can affect the drug's efficacy, safety, and pharmacokinetics. Detecting potential immunogenic reactions early in the drug development process helps mitigate risks associated with adverse reactions in patients. </p> </li> <li> <span class="sFAQTit">What role does protein aggregation play in the immunogenicity of biotherapeutic drugs?</span> <p> Protein aggregation can significantly increase the immunogenicity of biotherapeutic drugs. Aggregated proteins can be more readily recognized by the immune system as foreign, leading to an enhanced immune response. Therefore, assessing and controlling aggregation during the formulation and stability testing phases is critical to minimize immunogenic potential. </p> </li> <li> <span class="sFAQTit">How do post-translational modifications affect the immunogenicity of biotherapeutics?</span> <p> Post-translational modifications (PTMs) such as glycosylation, oxidation, deamidation, and phosphorylation can alter the physical and chemical properties of a protein, potentially making it more immunogenic. Differences in PTMs between a biotherapeutic and endogenous proteins, or batch-to-batch variations in these modifications, can trigger immune responses. Immunogenicity testing must therefore evaluate the impact of PTMs on the drug's immunogenic profile. </p> </li> <li> <span class="sFAQTit">Can immunogenicity be predicted during the early stages of biotherapeutic development?</span> <p> While predicting immunogenicity with complete accuracy in the early stages is challenging, certain in silico and in vitro techniques can provide early indications. These include computational tools for predicting T-cell epitopes and in vitro assays using human immune cells to assess the immunogenic potential. These predictions, however, must be validated with clinical data as the development progresses. </p> </li> <li> <span class="sFAQTit">What is the difference between binding antibodies and neutralizing antibodies in the context of immunogenicity?</span> <p> Binding antibodies are those that bind to a biotherapeutic drug but do not necessarily interfere with its biological activity. In contrast, neutralizing antibodies bind to the drug and inhibit its therapeutic function, directly impacting its efficacy. Immunogenicity assessments typically screen for both types of antibodies, but special attention is given to the detection and characterization of neutralizing antibodies due to their clinical implications. </p> </li> <li> <span class="sFAQTit">What are the challenges associated with immunogenicity testing in clinical trials?</span> <p> Immunogenicity testing during clinical trials faces several challenges, including the variability in patient responses, the sensitivity and specificity of assays, and the interpretation of how immunogenicity impacts clinical outcomes. Additionally, the presence of drug in patient samples can interfere with immunogenicity assays, making it difficult to detect anti-drug antibodies. Overcoming these challenges requires robust assay development and validation, as well as careful analysis of clinical data. </p> </li> </ol> <h2 class="h2_tit page_tab_margin" id="tab5"> Resources </h2> <p> Use the resources in our library to help you understand your options and make critical decisions for your study. </p> <div class="tab_nav"> <span class="tab_choosebg">Videos</span><span>Articles</span> </div>  <div class="tab_cont" style="display:block;"> <div class="row pagerow_pt"> <div class="col-md-4"> <div class="pagerow_pt_unit"> <img loading="lazy" src="../static/img/immunogenicity-overview-of-therapeutic-biologics.jpg" alt="" /> </div> <a href="https://youtu.be/J430752_dTo" target="_blank">Immunogenicity overview of therapeutic biologics</a> </div> </div> </div>  <div class="tab_cont"> <div class="row pagerow_pt"> <div class="col-md-4"> <div class="pagerow_pt_unit_2"> <img loading="lazy" src="static/img/4-2-14-immune-monitoring-for-immunogenicity-assessment-1.jpg" alt="" /> </div> <a href="/immune-monitoring-for-immunogenicity-assessment.html">Immune Monitoring for Immunogenicity Assessment</a> </div> <div class="col-md-4"> <div class="pagerow_pt_unit_2"> <img loading="lazy" src="static/img/4-2-14-current-immunogenicity-evaluation-systems-a-deep-dive-by-creative-biolabs-1.jpg" alt="" /> </div> <a href="/current-immunogenicity-evaluation-systems.html">Current Immunogenicity Evaluation Systems: A Deep Dive by Creative Biolabs</a> </div> <div class="col-md-4"> <div class="pagerow_pt_unit_2"> <img loading="lazy" src="static/img/4-2-14-1-in-silico-immunogenicity-assessment-the-leading-edge-approach-to-drug-development-1.jpg" alt="" /> </div> <a href="/in-silico-immunogenicity-assessment-the-leading-edge-approach-to-drug-development.html"><i>In Silico</i> Immunogenicity Assessment: The Leading-edge Approach to Drug Development</a> </div> <div class="col-md-4"> <div class="pagerow_pt_unit_2"> <img loading="lazy" src="static/img/4-2-14-4-how-to-evaluate-the-immunogenicity-of-therapeutic-protein-drugs-in-vivo-1.jpg" alt="" /> </div> <a href="/how-to-evaluate-the-immunogenicity-of-therapeutic-protein-drugs-in-vivo.html">How to Evaluate the Immunogenicity of Therapeutic Protein Drugs <i>In Vivo</i></a> </div> <div class="col-md-4"> <div class="pagerow_pt_unit_2"> <img loading="lazy" src="static/img/4-2-14-5-the-origin-and-detection-methods-of-anti-drug-antibodies-1.jpg" alt="" /> </div> <a href="/the-origin-and-detection-methods-of-anti-drug-antibodies.html">The Origin and Detection Methods of Anti-Drug Antibodies</a> </div> <div class="col-md-4"> <div class="pagerow_pt_unit_2"> <img loading="lazy" src="static/img/4-2-14-1-8-immunogenic-risk-assessment-of-therapeutic-proteins-1.jpg" alt="" /> </div> <a href="/immunogenic-risk-assessment-of-therapeutic-proteins.html">Immunogenic Risk Assessment of Therapeutic Proteins</a> </div> <div class="col-md-4"> <div class="pagerow_pt_unit_2"> <img loading="lazy" src="static/img/anti-drug-antibody-introduction-1.jpg" alt="" /> </div> <a href="/anti-drug-antibody-introduction.html">Anti-Drug Antibody Introduction</a> </div> </div> </div> <script> window.addEventListener('load',function(){ // $(function () { $(".tab_nav span").click(function(){ var eqindex=$(this).index(); $(this).addClass("tab_choosebg"); $(this).siblings("span").removeClass("tab_choosebg"); $(".tab_cont").hide().eq(eqindex).show(); }) // }) }); </script><br> <p class="pronote"><i class="fa fa-exclamation-triangle"></i>All listed services and products are For Research Use Only. 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