Immunogenicity · 360biolabs

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aria-hidden="false">Open menu</span> </button> <a href="https://www.360biolabs.com/contact/" class="button has-gradient button-contact"> <span>Connect With Us</span> </a> </div> </div> </div> </div> </header> <main id="main-content"> <section class="content-block block-services-hero has-zaffre-fair-bg"> <div class="container is-default"> <div class="column-content" data-neruda-anim="fade-in" data-neruda-anim-duration="1s" data-neruda-anim-delay=".25s"> <h1>Immunogenicity</h1> <div class="intro-content"> <p>All biotherapeutics have the potential to trigger an immune response, generating anti-drug antibodies (ADAs) that bind to different epitopes on the therapeutic antigen. The FDA and EMA recommend a multi-tiered strategy for the evaluation of immunogenicity. It is a regulatory expectation to monitor and characterise the ADAs specific to a biotherapeutic to evaluate efficacy and safety. As a world-leading authority in the field of immunogenicity testing, 360biolabs understands how to best characterise ADAs and even particular isotypes.</p> </div> </div> </div> <img src="https://www.360biolabs.com/wp-content/themes/cc-360biolabs/assets/images/hero-shape.svg" alt="Decorative image" class="bottom-decoration" data-neruda-anim="hero-shape"> <div class="icon-bg" style="background-image:url('https://www.360biolabs.com/wp-content/themes/cc-360biolabs/assets/images/icons-library/icon-immunoassays-default.svg')" data-neruda-anim="fade-left"></div> </section> <div class="services-page-anchor"> <div class="button-page-scroll-container"> <a href="#page-content" class="button-page-scroll"> <span aria-hidden="false">Scroll to page content</span> </a> </div> <a id="page-content"></a> </div> <section class="content-block block-pill-image-text"> <div class="container is-wide"> <div class="columns"> <div class="column-content"> <div class="inner-padding"> <h2>Expertise With Immunogenicity Assays:</h2> <div class="features-container"> <div class="feature" style="background-image:url('https://www.360biolabs.com/wp-content/themes/cc-360biolabs/assets/images/icons-library/icon-measuring-cylinder-circle.svg');"> <h3>Extensive Experience </h3> <p>Our team possesses a deep understanding of antibody-antigen interactions, immune responses, and neutralisation assays.聽</p> </div> <div class="feature" style="background-image:url('https://www.360biolabs.com/wp-content/themes/cc-360biolabs/assets/images/icons-library/icon-science-driven-circle.svg');"> <h3>Custom Assay Solutions</h3> <p>Our expert immunology team can develop custom assays for immunogenicity testing and validate them to global regulatory standards.聽</p> </div> <div class="feature" style="background-image:url('https://www.360biolabs.com/wp-content/themes/cc-360biolabs/assets/images/icons-library/icon-quality-circle.svg');"> <h3>FDA/EMA Standards</h3> <p>We understand FDA and EMA recommendations, ensuring accurate and robust data on immunogenicity.聽</p> </div> <div class="feature" style="background-image:url('https://www.360biolabs.com/wp-content/themes/cc-360biolabs/assets/images/icons-library/icon-lab-flask-circle.svg');"> <h3>Modalities & Therapeutic areas</h3> <p>We have experience across different modalities and therapeutic areas.</p> </div> </div> </div> </div> <div class="column-image"> <div class="image-container" > <figure> <img width="1920" height="1280" src="https://www.360biolabs.com/wp-content/uploads/PK_ADA_9575.webp" class="attachment-full size-full" alt="Scientists in biosafety cabinet accurately pipetting samples for an immunogenicity assay" decoding="async" fetchpriority="high" srcset="https://www.360biolabs.com/wp-content/uploads/PK_ADA_9575.webp 1920w, https://www.360biolabs.com/wp-content/uploads/PK_ADA_9575-600x400.webp 600w, https://www.360biolabs.com/wp-content/uploads/PK_ADA_9575-1400x933.webp 1400w, https://www.360biolabs.com/wp-content/uploads/PK_ADA_9575-768x512.webp 768w, https://www.360biolabs.com/wp-content/uploads/PK_ADA_9575-1536x1024.webp 1536w" sizes="(max-width: 1920px) 100vw, 1920px" /> </figure> <div class="shape has-cyan-fair-bg" ></div> </div> <div class="section-action"> <a href="https://www.360biolabs.com/contact/" target="_self">Make the right bioanalytical method selection with our help</a> </div> </div> </div> </div> </section> <section class="content-block block-modalities-assays is-immunogenicity"> <div id="ADAs" class="section-top has-steel-fair-bg"> <div class="container"> <div class="inner-padding"> <h2>360biolabs Assay Solutions</h2> <div class="services-container"> <div class="service-card" style="background-image:url('https://www.360biolabs.com/wp-content/themes/cc-360biolabs/assets/images/icons-library/icon-immunogenicity-default.svg')"> <h3>Anti-Drug Antibodies (ADA)</h3> <p>All biotherapeutics have the potential to trigger an immune response, generating anti-drug antibodies (ADAs) that bind to different epitopes on the therapeutic protein. It is a regulatory expectation to monitor and characterise the ADAs specific to a biotherapeutic to evaluate efficacy and safety.</p> <p>360biolabs offers a complete ADA determination process:</p> <ul> <li>Screening assays</li> <li>Confirmatory assays</li> <li>Titer assays</li> <li>Characterisation assays</li> <li>Neutralising Assay (NAb)</li> </ul> </div> </div> </div> <div class="bg-icon" style="background-image:url('https://www.360biolabs.com/wp-content/themes/cc-360biolabs/assets/images/icons-library/icon-immunogenicity-default.svg')"></div> </div> </div> <div id="NAbs" class="section-bottom"> <div class="container is-wide"> <div class="columns"> <div class="column column-text"> <div class="services-container"> <div class="service-card" style="background-image:url('https://www.360biolabs.com/wp-content/themes/cc-360biolabs/assets/images/icons-library/icon-neutralising-abs-default.svg')"> <h3>Neutralising Antibodies (NAb)</h3> <p>Neutralising Antibodies (NAbs) can inhibit or completely neutralise a therapeutic molecule by binding to regions critical for pharmacological activity, impacting clinical efficacy. Understanding the impact of NAbs is critical to progressing any clinical program.</p> </div> <div class="section-actions"> <a href="https://www.360biolabs.com/contact/" target="_self" class="button"> <span>Discuss Clinical Study</span> </a> <a href="https://www.360biolabs.com/australian-locations/" target="_self" class="button is-outlined"> <span>Locations</span> </a> </div> </div> </div> <div class="column column-image"> <div class="image-container"> <figure> <img width="1920" height="1279" src="https://www.360biolabs.com/wp-content/uploads/LCMS_sciex-instrument_9173.webp" class="attachment-full size-full" alt="Measuring circulating drug concentrations for a PK study via A Sciex LC-MS/MS instrument" decoding="async" srcset="https://www.360biolabs.com/wp-content/uploads/LCMS_sciex-instrument_9173.webp 1920w, https://www.360biolabs.com/wp-content/uploads/LCMS_sciex-instrument_9173-600x400.webp 600w, https://www.360biolabs.com/wp-content/uploads/LCMS_sciex-instrument_9173-1400x933.webp 1400w, https://www.360biolabs.com/wp-content/uploads/LCMS_sciex-instrument_9173-768x512.webp 768w, https://www.360biolabs.com/wp-content/uploads/LCMS_sciex-instrument_9173-1536x1023.webp 1536w" sizes="(max-width: 1920px) 100vw, 1920px" /> </figure> <div class="shape"></div> </div> <div class="section-action"> <a href="https://www.360biolabs.com/contact/" target="_self"> <span>Learn how we support your custom assays</span> </a> </div> </div> </div> </div> </div> <div class="hero-image content-block block-hero-image has-half-bg"> <div class="container is-default"> <figure> <img width="1920" height="1105" src="https://www.360biolabs.com/wp-content/uploads/DSC09200.webp" class="attachment-full size-full" alt="Scientist working at a lab bench conducting anti-drug antobody testing for an immunogenicity study" decoding="async" srcset="https://www.360biolabs.com/wp-content/uploads/DSC09200.webp 1920w, https://www.360biolabs.com/wp-content/uploads/DSC09200-600x345.webp 600w, https://www.360biolabs.com/wp-content/uploads/DSC09200-1400x806.webp 1400w, https://www.360biolabs.com/wp-content/uploads/DSC09200-768x442.webp 768w, https://www.360biolabs.com/wp-content/uploads/DSC09200-1536x884.webp 1536w" sizes="(max-width: 1920px) 100vw, 1920px" /> </figure> </div> </div> </section> <section class="content-block block-related-content"> <div class="container"> <h2 class="is-centered">Related Content</h2> <div class="columns"> <div class="column"> <figure> <img width="600" height="281" src="https://www.360biolabs.com/wp-content/uploads/BioAgilytex-San-Diego-Lab-600x281.webp" class="attachment-medium size-medium" alt="BioAgilytex - San Diego lab" decoding="async" loading="lazy" srcset="https://www.360biolabs.com/wp-content/uploads/BioAgilytex-San-Diego-Lab-600x281.webp 600w, https://www.360biolabs.com/wp-content/uploads/BioAgilytex-San-Diego-Lab-768x359.webp 768w, https://www.360biolabs.com/wp-content/uploads/BioAgilytex-San-Diego-Lab.webp 1124w" sizes="(max-width: 600px) 100vw, 600px" /> </figure> <div class="text-container"> <h3>Blog: ADA </h3> <div class="column-blurb"> <p>Read our latest blog on Characterizing Anti-Drug Antibodies in Clinical Trials.</p> </div> <p class="column-action"> <a href="https://www.360biolabs.com/characterizing-anti-drug-antibodies-in-clinical-trials/"> Learn more</a> </p> </div> </div> <div class="column"> <figure> <img width="600" height="400" src="https://www.360biolabs.com/wp-content/uploads/Biomarkers_6653-600x400.webp" class="attachment-medium size-medium" alt="Scientists in lab pipetting samples for biomarker testing on The MesoScale Discovery platform (MSD)" decoding="async" loading="lazy" srcset="https://www.360biolabs.com/wp-content/uploads/Biomarkers_6653-600x400.webp 600w, https://www.360biolabs.com/wp-content/uploads/Biomarkers_6653-1400x933.webp 1400w, https://www.360biolabs.com/wp-content/uploads/Biomarkers_6653-768x512.webp 768w, https://www.360biolabs.com/wp-content/uploads/Biomarkers_6653-1536x1024.webp 1536w, https://www.360biolabs.com/wp-content/uploads/Biomarkers_6653.webp 1920w" sizes="(max-width: 600px) 100vw, 600px" /> </figure> <div class="text-container"> <h3>Ligand-binding Assays/Immunoassay </h3> <div class="column-blurb"> <p>360biolabs are industry leaders in immunoassay development and validation, with extensive experience across a wide range of methodologies.</p> </div> <p class="column-action"> <a href="https://www.360biolabs.com/ligand-binding-assays-immunoassays/"> Learn more</a> </p> </div> </div> <div class="column"> <figure> <img width="600" height="400" src="https://www.360biolabs.com/wp-content/uploads/PK_ADA_9547-600x400.webp" class="attachment-medium size-medium" alt="Scientist accurately pipetting in biosafety cabinet" decoding="async" loading="lazy" srcset="https://www.360biolabs.com/wp-content/uploads/PK_ADA_9547-600x400.webp 600w, https://www.360biolabs.com/wp-content/uploads/PK_ADA_9547-1400x933.webp 1400w, https://www.360biolabs.com/wp-content/uploads/PK_ADA_9547-768x512.webp 768w, https://www.360biolabs.com/wp-content/uploads/PK_ADA_9547-1536x1024.webp 1536w, https://www.360biolabs.com/wp-content/uploads/PK_ADA_9547.webp 1920w" sizes="(max-width: 600px) 100vw, 600px" /> </figure> <div class="text-container"> <h3>Pharmacokinetics </h3> <div class="column-blurb"> <p>We offer comprehensive PK assay development, validation, and sample testing for various drug modalities and sample types.</p> </div> <p class="column-action"> <a href="https://www.360biolabs.com/pharmacokinetics/"> Learn more</a> </p> </div> </div> </div> </div> </section> </main> <section class="block-footer-cta"> <div class="container is-default"> <div class="columns"> <div class="column-text"> <p>Enabling future medicine together. 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Immunogenicity · 360biolabs