CINXE.COM

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To support this, all of our teams that carry out bioanalysis comply with the current standards for Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). </p> <div class="wp-block-group container"> <div class="wp-block-image"><figure class="aligncenter size-full is-resized"><img src="https://ecdn.syneoshealth.com/s3fs-public/2024-11/bioanalytical_services_map_no_text_chart%402x.png?VersionId=zTi0zPEFLRoeQYmzXxSDe8GXIKq_naNt" alt="" class="wp-image-1511" width="1056" height="582" data-entity-type="file" data-entity-uuid="729d5e75-36c8-4fdf-9aab-4cc8a7a0b0a7" data-image-style="original"/></figure></div> </div> <hr class="wp-block-separator"/> <div style="height:53px" aria-hidden="true" class="wp-block-spacer"></div> <ul class="container padding-horizontal"><li><strong>2</strong> GLP/GCP-compliant bioanalysis laboratories with robotics and LIMS to provide you with consistent, accurate data </li><li><strong>18</strong> audits from regulatory agencies (including FDA, EMA, HC, ANVISA) in past 5 years</li><li><strong>30+</strong> years of operations</li><li><strong>24</strong> hours per day, 7 days per week operation </li><li><strong>95%+</strong> ISR performance </li><li><strong>380</strong> dedicated bioanalytical professionals </li><li><strong>500+</strong> projects completed annually </li><li><strong>>375,000+</strong> samples analyzed annually</li></ul> <div style="height:68px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-sh-card-image-panel btn-off container rounded smaller-version shadow" data-type="sh/card-image-panel"><div><section><div class="row g-0"> <div class="wp-block-column col-12 col-xl"> <figure class="wp-block-image size-card_image_panel_660x660_"><img src="https://syneoshealth-corp.s3.amazonaws.com/s3fs-public/styles/card_image_panel_660x660_/public/2023-05/linkedin-sales-solutions-EI50ZDA-l8Y-unsplash.jpg?VersionId=HWHP9mih2JQGGFWt8jos40pMu2Frgqs6&itok=mqXvXaNx" alt="" class="wp-image-342" data-entity-type="file" data-entity-uuid="797664ec-9cf4-4f68-a745-0141de3265ff" data-image-style="original" /></figure></div> <div class="wp-block-column col-12 col-xl align-items-center d-flex"> <div class="wp-block-group col-card"> <h2>We honor our commitments</h2> <p>Our bioanalytical services center around delivering on our commitment to meet project schedules without compromising quality and compliance. Because we recognize your need for fast turnaround, method development and proof-of-concept can typically be performed within a few days, enabling quick go/no-go decisions.</p> <div class="wp-block-buttons"> <div class="wp-block-button is-style-primary"><a class="wp-block-button__link has-luminous-vivid-orange-to-vivid-red-gradient-background has-background" href="/contact-us">Contact us</a></div> </div> </div> <div class="wp-block-buttons"></div> </div> </div></section></div></div> <div style="height:37px" aria-hidden="true" class="wp-block-spacer"></div> <h2 class="has-text-align-center has-orange-color has-text-color margin">Large and diverse capacity</h2> <p class="container">We take the “full capability” approach to bioanalytical services, regardless of your project size. Through our GLP-compliant laboratories, an extensive list of validated assays, custom assay services, knowledgeable scientists and skilled technicians, we provide bioanalytical services at all stages of drug development.</p> <p class="container">Then, we combine our significant experience with small and large molecules, peptides, immunochemistry, LC/MS/MS, HRMS, GC/MS/MS, ICP-MS and blend innovative science with efficient, validated processes.</p> <h2 class="has-text-align-center has-orange-color has-text-color margin">In-house expertise and modern instrumentation for rapid turnaround times</h2> <p class="container">We have a long history of partnering with biopharmaceutical companies for in vivo, non-regulated preclinical bioanalysis of plasma and tissue samples. We have in-house expertise and access to a sophisticated array of modern instrumentation that enables rapid turnaround times.</p> <p class="container">Customers look to us to develop bioanalytical methods and assay samples generated in a non-GLP, high-throughput environment and to report sample concentrations with preliminary pharmacokinetics (PK) using WinNonlin<sup>®</sup> or Watson LIMS.</p> <p class="container">We offer HRMS-based methods, as well as traditional multiple reaction monitoring (MRM) assays using ultra-performance liquid-chromatography (UPLC) triple quadrupole LC/MS/MS analysis for PK work. We also offer specialized expertise in tissue analysis to support drug distribution studies, proteins, peptides, ADCs and nucleotides.</p> <p class="container">Our process is standardized around a robotics platform, which allows for improved precision, better reproducibility and fewer errors. We offer protein binding, bioavailability, early toxicology and method qualification services for the target compound, as well as its metabolites.</p> <div style="height:56px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-sh-card-image-panel btn-off container rounded shadow" data-type="sh/card-image-panel"><div><section><div class="row g-0 flex-row-reverse "> <div class="wp-block-column col-12 col-xl"> <figure class="wp-block-image size-card_image_panel_660x660_"><img src="https://syneoshealth-corp.s3.amazonaws.com/s3fs-public/styles/card_image_panel_660x660_/public/2022-07/image9977.jpg?VersionId=aAzXP7qx3gKSEVmStQ6LA8uI3WiZpELW&itok=i1Fcdg1p" alt="" class="wp-image-75" data-entity-type="file" data-entity-uuid="af94885c-c82d-485d-ada2-0f6d1a95422c" data-image-style="original" /></figure></div> <div class="wp-block-column col-12 col-xl align-items-center d-flex"> <div class="wp-block-group col-card"> <h2>Method development and validation</h2> <p>We offer custom method development, assay validation and sample analysis using state-of-the-art LC/MS/MS and immunochemistry assays and a team of detail-oriented scientists. Our staff has developed LC/MS/MS methods including routinely quantifying levels below one pg/mL.</p> <p>We have methods for multiple analytes, metabolites, prodrugs and light- and temperature-sensitive compounds. Standard timelines for validation is around 5–10 days.</p> <div class="wp-block-button is-style-primary template-bt"><a class="wp-block-button__link" href="#">Discover Syneos One</a></div> </div> </div> </div></section></div></div> <div style="height:33px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-sh-card-image-panel btn-off container rounded shadow" data-type="sh/card-image-panel"><div><section><div class="row g-0"> <div class="wp-block-column col-12 col-xl"> <figure class="wp-block-image size-card_image_panel_660x660_"><img src="/s3/files/styles/card_image_panel_660x660_/public/2023-05/GettyImages-525386717.jpg?itok=7R_ZiT2k" alt="" class="wp-image-321" data-entity-type="file" data-entity-uuid="96f2dbc0-d1e5-483f-a185-b1f7d715d4ee" data-image-style="original" /></figure></div> <div class="wp-block-column col-12 col-xl align-items-center d-flex"> <div class="wp-block-group col-card"> <h2>Ligand binding</h2> <p>We provide a growing menu of standard and custom assays optimized for the quantitation of multiple analytes (proteins) in serum, EDTA and heparin, as well as sodium citrate plasma, culture supernatant and other sample types.</p> <p>Our immunoassay capabilities include single analytes and multiplexing. Services include development, optimization and validation of proprietary assays, transfer and validation of existing assays and validation of commercially available kits.</p> <p>Significant experience in the development and validation of immunoassays for large molecules and biomarkers gives our clinical scientists special insight into the development of bioanalytical technologies. Work performed in our GLP-compliant immunochemistry facilities includes proprietary and non-proprietary pharmacokinetic and immunogenicity assays, as well as a wide range of cell-based and enzymatic assays.</p> <p>By rapidly providing specialized immunogenicity testing for the presence of antibodies to biologic and biosimilar products, we can help move your large molecule development programs forward quickly and smoothly.</p> <p>Our bioanalytical technologies and experience allows applications of a variety of immunoassay platforms, including: electrochemiluminescence (ECL), ELISA, fluorescence, luminescence and radioimmunoassays.</p> <div class="wp-block-button is-style-primary template-bt"><a class="wp-block-button__link" href="#">Discover Syneos One</a></div> </div> </div> </div></section></div></div> <div style="height:44px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-sh-card-image-panel btn-off container rounded shadow" data-type="sh/card-image-panel"><div><section><div class="row g-0 flex-row-reverse "> <div class="wp-block-column col-12 col-xl"> <figure class="wp-block-image size-card_image_panel_660x660_"><img src="/s3/files/styles/card_image_panel_660x660_/public/2023-05/GettyImages-1089913166.jpg?itok=40hvjJM-" alt="" class="wp-image-397" data-entity-type="file" data-entity-uuid="a8d268d4-425e-47e2-95e7-56138b7af0e2" data-image-style="original" /></figure></div> <div class="wp-block-column col-12 col-xl align-items-center d-flex"> <div class="wp-block-group col-card"> <h2>Quantitative biomarkers</h2> <p>We provide mass spectrometry-based and immunochemical analyses for the development, validation and measurement of biomarkers, including targeted and non-targeted biochemical and protein profiling. Our methods ensure precise, accurate measurement of biomarkers for therapeutic disease endpoints for infectious and autoimmune diseases, cardiovascular risk, and blood components including hormones, cytokines, chemokines and acute-phase reactants.</p> <div class="wp-block-button is-style-primary template-bt"><a class="wp-block-button__link" href="#">Discover Syneos One</a></div> </div> </div> </div></section></div></div> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-sh-card-image-panel btn-off container rounded shadow" data-type="sh/card-image-panel"><div><section><div class="row g-0"> <div class="wp-block-column col-12 col-xl"> <figure class="wp-block-image size-card_image_panel_660x660_"><img src="/s3/files/styles/card_image_panel_660x660_/public/2023-05/national-cancer-institute-oCLuFi9GYNA-unsplash.jpg?itok=x8-TDUex" alt="" class="wp-image-377" data-entity-type="file" data-entity-uuid="576a886d-88e4-4c67-9f99-0d289269729e" data-image-style="original" /></figure></div> <div class="wp-block-column col-12 col-xl align-items-center d-flex"> <div class="wp-block-group col-card"> <h2>ICP-MS</h2> <p>We offer ICP-MS to support (but not limited to) oncology trials. In the past decade, the advances in oncology medication, pain relief, chemotherapy or other therapy has dramatically changed the way cancer is diagnosed and treated.</p> <p>Carboplatin and cisplatin are chemotherapy medications used to treat a number of forms of cancer. These compounds contain the element platinum that can be analyzed using the inductively-coupled plasma mass spectrometry or ICP-MS. </p> <p>This instrument is designed for the analysis of natural elements such as platinum, iron, sodium, lithium and potassium. The diluted sample extracts are introduced in an argon plasma torch to be nebulized and ions are directed towards the quadrupole filer of the mass spectrometry detector by a set of lenses.</p> <p>We have extended our expertise throughout the years and have validated several assays for the analysis of elements such as platinum, iron, sodium, potassium, zinc, lithium, strontium and bismuth. We have recently developed a combo assay for the measurement of magnesium, calcium and phosphorus in human serum and urine.</p> <p>These methods are validated as per the most recent regulatory guidelines for bioanalytical method validations. Most of them were used successfully for study sample analyses. Other areas of interest include biomarkers (Na, K, Mg, Ca, Fe, PO4) and metal-based drugs (Li, K, SR, Bi, Zn, Pt).</p> <div class="wp-block-button is-style-primary template-bt"><a class="wp-block-button__link" href="#">Discover Syneos One</a></div> </div> </div> </div></section></div></div> <div style="height:34px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-sh-card-image-panel btn-off container margin-bottom rounded shadow" data-type="sh/card-image-panel"><div><section><div class="row g-0 flex-row-reverse "> <div class="wp-block-column col-12 col-xl"> <figure class="wp-block-image size-card_image_panel_660x660_"><img src="/s3/files/styles/card_image_panel_660x660_/public/2023-05/ibrahim-boran-zsKFQs2kDpM-unsplash.jpg?itok=FNjZTmVC" alt="" class="wp-image-363" data-entity-type="file" data-entity-uuid="ffa5c19d-90ec-41a3-a6a0-1cc76b98f73f" data-image-style="original" /></figure></div> <div class="wp-block-column col-12 col-xl align-items-center d-flex"> <div class="wp-block-group col-card"> <h2>Ensuring the best quality and highest consistency of critical reagents</h2> <p>Successful Ligand Binding Assays (LBAs) are dependent on the use of quality critical reagents. Lot-to-lot inconsistencies can cause changes in assay reproducibility, robustness and accuracy. By ensuring uniformity throughout the life cycle of a critical reagent’s use, we can effectively eliminate the need for tedious and costly assay bridging and, perhaps, revalidation.</p> <p>By employing Preparative SEC, Analytical SEC, High Resolution Mass Spectrometry and Tangential Flow Filtration, our lab has established a rigorous and flexible method by which aggregation, purity and incorporation ratio (label:protein) can all be accurately quantitated and reported during the production and life cycle of the reagent.</p> <div class="wp-block-button is-style-primary template-bt"><a class="wp-block-button__link" href="#">Discover Syneos One</a></div> </div> </div> </div></section></div></div> </div> </div> </div> </div> </section> </main> </div> </div> </div> <div class="container-fluid" id="get-in-touch"> <div class="container"> <div class="row flex-column flex-md-row align-items-center"> <div class="col logo text-center text-md-start mb-5 mb-md-0"> <a href="/"><img alt="Syneos Health logo" title="Syneos Health logo" src="https://ecdn.syneoshealth.com/s3fs-public/2023-05/syneos_logo_white.png?VersionId=vYInAS1QgzWmNpVV8ozGkm1jZOMXtOH0" typeof="foaf:Image" /> </a> </div> <div class="col social d-flex flex-row justify-content-center justify-content-md-start mb-5 mb-md-0"> <div class="me-3"> <a href="https://www.linkedin.com/company/11408925/" target="_blank" rel="noreferrer"><img alt="LinkedIn icon" title="LinkedIn icon" src="https://ecdn.syneoshealth.com/s3fs-public/2023-05/linkedin.png?VersionId=10ddZu8mqduauIXgBtX71xfWHkYM0J2f" typeof="foaf:Image" /> </a> </div> <div class="me-3"> <a href="https://twitter.com/syneoshealth" target="_blank" rel="noreferrer"><img alt="Twitter icon" title="Twitter icon" src="https://ecdn.syneoshealth.com/s3fs-public/2023-05/twitter.png?VersionId=mhx3LKvPRdMZVB.25_QRXgdjYRceazlX" typeof="foaf:Image" /> </a> </div> <div> <a href="https://www.facebook.com/SyneosHealth/" target="_blank" rel="noreferrer"><img alt="Facebook icon" title="Facebook icon" src="https://ecdn.syneoshealth.com/s3fs-public/2023-05/facebook.png?VersionId=IL1Q6eO.l_EmS_wDUxlqllQC1qMkoQgM" typeof="foaf:Image" /> </a> </div> </div> <div class="col col-md-auto flex-column flex-md-row text-end d-flex flex-row align-items-center"> <div class="me-md-3 mb-3 mb-md-0"> <span class="copy">Interested in Syneos Health?</span> </div> <div> <a href="/contact-us" class="btn btn-secondary">Get In Touch</a> </div> </div> </div> </div> </div> <footer class="site-footer"> <div class="container"> <div class="site-footer__top clearfix row"> <section class="col-md-4 region region-footer-first"> <div id="block-footertext-2" class="block block-block-content block-block-content15c76c29-fe56-4295-b46d-48697f581986"> <div class="content"> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><p>Syneos Health<sup>® </sup>is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. 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