Analyzing the Pharmacokinetics of Monoclonal Antibodies

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Move beyond ELISAs with quantitative, high-sensitivity PK assays directly in complex lysates and tissue homogenates.</p></div> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> </div> </div> </div> </div> </div> </div> </div> </section> </div> </div> </header> </div> <div id="main" class="container-fluid container-wide"> <div class="row"> <div class="col-md-12"> <div> <div id="block-bio-techne-global-breadcrumbs" class="system_breadcrumb_block"> <nav role="navigation" aria-labelledby="system-breadcrumb"> <h2 id="system-breadcrumb" class="visually-hidden">Breadcrumb</h2> <ol> <li> <a href="/">Home</a> </li> <li> <a href="/resources">Resources</a> </li> <li> <a href="/resources/instrument-applications">ProteinSimple Instrument Applications</a> </li> <li> Pharmacokinetics of Monoclonal Antibodies </li> </ol> </nav> </div> </div> </div> </div> <main> <section class="section"> <div> <div id="block-bio-techne-global-content" class="system_main_block"> <article> <div> <div> <div> <div class="paragraph paragraph--type--section paragraph--view-mode--default mb-4"> <div> <div> <div class="paragraph paragraph--type--_-1-text-to-media mb-4 paragraph--view-mode--default"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--75-25"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:3_1_text_to_media:field_header_2_global"> <div><h2>Simple Western PK Assay</h2></div> </div> <div class="field_block:paragraph:3_1_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p><a href="/instruments/simple-western">Simple Western™</a> is a fully automated capillary immunoassay. Separate proteins by <a href="/instruments/simple-western/simple-western-assays-charge-based-separation">capillary isoelectric focusing (cIEF)</a> or<a href="/instruments/simple-western/simple-western-assays-utilizing-size-based-separation"> capillary electrophoresis sodium dodecyl sulfate (CE-SDS)</a> followed seamlessly by immunodetection directly in the capillary.</p> <ul> <li><strong>Reproducible quantification.</strong> Use CE-SDS to resolve proteins by size and quantify intact IgG, aggregates and fragments IC/EC<sub>50</sub>, LOD, LOQ, and more, with intra- and inter-assay CVs of <20%.</li> <li><strong>Add a Size- or Charge-base separation to your immunoassay. </strong>Use CE-SDS to resolve proteins by size and quantify intact IgG, aggregates and fragments. Use cIEF to quantify the main peak, acidic peak(s), and basic peak(s) of your antibody therapeutic.</li> </ul></div> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:3_1_text_to_media:field_indv_media"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/bt-simple-western-instruments-hero.png" alt="Simple Western Instruments - Jess & Peggy Sue Hero" loading="lazy" > </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--_-1-text-to-media mb-4 paragraph--view-mode--default"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--75-25"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:3_1_text_to_media:field_header_2_global"> <div><h3>PK Analysis of Biosimilar Monoclonal Antibodies</h3></div> </div> <div class="field_block:paragraph:3_1_text_to_media:field_lg_sngl_frmtd_text_global"> <div><ul> <li><strong>No sample cleanup.</strong> Analyze highly complex samples like human serum without lengthy purification or concentration steps.</li> <li><strong>High throughput.</strong> Process up to 96 samples in one overnight run without user intervention.</li> <li><strong>High sensitivity.</strong> Highly sensitive immunodetection using as little as 3 µL of sample. Get up to 8 data points on the same 5 µL of sample. <a href="/instruments/simple-western/multiplex-protein-analysis-simple-western" target="_blank">Multiplex </a>to get more data points per sample with chemiluminescence and <a href="/instruments/simple-western/stellar-nir-ir-fluorescence-detection-modules">Stellar™ NIR/IR fluorescence detection with industry-leading sensitivity</a>. Use <a href="/instruments/simple-western/one-sample-two-western-immunoassay-replex-jess-abby">RePlex™ </a>to perform sequential immunoassays or Total Protein Detection on the same sample.</li> <li><strong>3-4 log dynamic range. </strong>Larger than ELISA.</li> </ul></div> </div> <div class="field_block:paragraph:3_1_text_to_media:field_call_to_action_global"> <a href="/resources/literature/pharmacokinetic-assays-with-simple-western" class="btn btn-primary" type="link"> Download PK App Note </a> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:3_1_text_to_media:field_indv_media"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/literature/an-simple-western-pharmacokinetics-biosimilar-thumbnail.png" alt="Simple Western Pharmacokinetic Biosimilar Monoclonal Antibody AN Thumbnail" loading="lazy" > </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--_-2-media-to-text mb-4 paragraph--view-mode--default"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--50-50"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:2_2_media_to_text:field_indv_media"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/instruments/assays-pk-biosimilars-analysis.png" alt="Pharmacokinetic evaluation of therapeutic monoclonal antibodies and their biosimilars." loading="lazy" > </div> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:2_2_media_to_text:field_header_2_global"> <div><h3>Combine CE-SDS/cIEF with Immunodetection</h3></div> </div> <div class="field_block:paragraph:2_2_media_to_text:field_lg_sngl_frmtd_text_global"> <div><figure class="responsive-figure-table"><table class="table table-bordered"> <thead> <tr> <th class="bt-blue-table-header"> </th> <th class="bt-blue-table-header">ELISA</th> <th class="bt-blue-table-header">CE-SDS</th> <th class="bt-blue-table-header">cIEF</th> <th class="bt-blue-table-header">Simple Western</th> </tr> </thead> <tbody> <tr> <td>Immunodetection</td> <td>Yes</td> <td>No</td> <td>No</td> <td><strong>Yes</strong></td> </tr> <tr> <td>Charge separation</td> <td>No</td> <td>No</td> <td>Yes</td> <td><strong>Yes</strong></td> </tr> <tr> <td>Size separation</td> <td>No</td> <td>Yes</td> <td>No</td> <td><strong>Yes</strong></td> </tr> </tbody> </table></figure></div> </div> <div class="field_block:paragraph:2_2_media_to_text:field_call_to_action_global"> <a href="/p/instruments/simple-western/request-quote" class="btn btn-primary" type="link"> Request Simple Western Pricing </a> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--_-1-text-to-media mb-4 paragraph--view-mode--default"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--75-25"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:3_1_text_to_media:field_header_2_global"> <div><h3>Quantitative Protein Characterization in Complex Samples</h3></div> </div> <div class="field_block:paragraph:3_1_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>The <a href="/instruments/simple-western">Simple Western</a> PK assay on <a href="/p/simple-western/peggy-sue_004-800">Peggy Sue™</a> combines the separation power of <a href="/p/imaged-capillary-electrophoresis-ice/maurice-c_090-002">cIEF </a>and <a href="https://www.proteinsimple.com/ce-sds-analysis-method-benefits-with-maurice.html" target="_blank">CE-SDS</a> assays with the sensitive and specific detection of an immunoassay. This combination places Simple Western in a unique position to study the pharmacokinetics of monoclonal antibodies and their biosimilars.</p> <ul> <li><strong>Minimal matrix effects.</strong> Following cIEF/CE-SDS separation, proteins are immobilized to the capillary and thoroughly washed prior to immunodetection, flushing the remaining sample matrix out of the capillary. Thus, immuno-probing on Simple Western occurs in an idealized environment rather than within the sample matrix environment, reducing <a href="/resources/literature/matrix-effect-tissue-homogenate-simple-western">matrix interference</a> that can plague ELISAs while also providing high-resolution charge/size separation. </li> <li><strong>Sensitive immunodetection. </strong>Detect small amounts (low pg) of target protein with <a href="/resources/simple-western-antibody-database">conventional Western blot antibodies</a>.</li> <li><strong>Upstream and downstream workflows. </strong>Obtain comparable charge separation profiles in crude samples from early stages of product development with <a href="/p/simple-western/peggy-sue_004-800">Peggy Sue</a> and later stages of purified samples with <a href="/p/imaged-capillary-electrophoresis-ice/maurice-c_090-002">Maurice cIEF</a>. For more information, refer to our Protocol on <a href="https://resources.bio-techne.com/bio-techne-assets/docs/protocols/pl7-0006-method-transfer-between-maurice-and-peggy-sue-reva.pdf">Method Transfer between Maurice and Peggy Sue.</a></li> </ul> <p>Simple Western PK analysis provides a complete picture of antibody pharmacokinetics in human serum.</p></div> </div> <div class="field_block:paragraph:3_1_text_to_media:field_call_to_action_global"> <a href="/resources/literature/pharmacokinetic-assays-with-simple-western" class="btn btn-primary" type="link"> View PK App Note </a> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:3_1_text_to_media:field_indv_media"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/instruments/simple-western-charge-technology.jpg" alt="Simple Western charge separation diagram" loading="lazy" > </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--_-3-media-to-text paragraph--view-mode--default mb-4"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--25-75"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:1_3_media_to_text:field_indv_media"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/icons/obt-fluorokines-related-resources-icon-116x116.png" alt="Related Resources Icon 116x116" loading="lazy" > </div> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:1_3_media_to_text:field_lg_sngl_frmtd_text_global"> <div><h2>Additional Resources</h2> <ul> <li><a href="/resources/literature/monoclonal-antibody-biosimilar-simple-western">Monitor Your mAb with Selectivity and Specificity for Upstream Bioprocessing</a></li> <li><a href="/resources/instrument-applications/bioprocess-contaminant-detection-using-simple-western">Bioprocess Impurity Detection</a></li> <li><a href="http://resources.bio-techne.com/bio-techne-assets/docs/protocols/pl7-0006-method-transfer-between-maurice-and-peggy-sue-reva.pdf" target="_blank">Transfer Your Method Between Upstream and Downstream Bioprocess Development</a></li> <li><a href="/resources/protocols-troubleshooting/protein-screening-on-simple-western">Protein Screening on Simple Western</a></li> <li><a href="https://resources.bio-techne.com/bio-techne-assets/docs/protocols/high-throughput-glycan-characterization-using-simple-western-revb.pdf" target="_blank">High-Throughput Glycan Characterization Using Simple Western</a></li> </ul></div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--_-1-text-to-media mb-4 paragraph--view-mode--default"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--75-25"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:3_1_text_to_media:field_lg_sngl_frmtd_text_global"> <div><h3>Bioprocess Workflow Solutions from Start to Finish</h3> <p>Look to us to provide top-quality instrumentation, reagents, and services for your <a href="/applications/bioprocessing">protein bioprocessing</a>. We offer an outstanding product selection and the flexibility to meet your specifications.</p> <ul> <li>Decades of experience in process development for cell culture and protein purification.</li> <li>World class reagent and assay development.</li> <li>Industry preferred technologies that simplify, automate, and advance protein analysis.</li> <li>Proven record of customer satisfaction for bulk supply, custom solutions, and documentation.</li> <li>Compliance with 21 CFR Part 11, ISO 13485:2016, USP <1043>, 21 CFR 820, and ISO 9001:2015 as applicable.</li> <li>Absolute confidentiality</li> </ul></div> </div> <div class="field_block:paragraph:3_1_text_to_media:field_call_to_action_global"> <a href="/resources/literature/bioprocess-workflow-solutions" class="btn btn-primary" type="link"> Bioprocess Workflow Solutions </a> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div 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