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border-color; } /* Style new checked item */ ul.inputs-list.multi-container li.hs-form-checkbox label span::after, .hs-form-booleancheckbox-display span::after { content: ""; border: 2px solid #d9d9d9; border-radius: 3px; height: 20px; left: 0px; position: absolute; top: 0px; width: 20px; background: #fff; z-index: 0; display: block; transition-property: background-color, border-color, -webkit-box-shadow; -o-transition-property: background-color, border-color, box-shadow; transition-property: background-color, border-color, box-shadow; transition-property: background-color, border-color, box-shadow, -webkit-box-shadow; } /* Show when checked */ ul.inputs-list.multi-container li.hs-form-checkbox label input:checked + span::after, .hs-form-booleancheckbox-display input:checked + span::after, ul.inputs-list.multi-container li.hs-form-checkbox label input:checked + span::before, .hs-form-booleancheckbox-display input:checked + span::before{ opacity: 1; } .hs-form-booleancheckbox-display input:checked+label:after, .hs-form-booleancheckbox-display input:checked+label:after { background: #fff; border-color: #157479; } /* Style when focused */ ul.inputs-list.multi-container li.hs-form-checkbox label input:focus + span::after, .hs-form-booleancheckbox-display input:focus + span::after { outline: 3px solid transparent; /* For Windows high contrast mode. */ box-shadow: 0 0 .3125rem rgba(0, 0, 0, .3); border-color: #157479; } .hs_contact_country{ clear: both; } .hs-button { border-radius: 65px !important; font-size: 14px; line-height: 1.3; letter-spacing: 1.12px; font-family: "Roboto Slab", helvetica, arial, sans-serif; font-weight: 700 !important; padding: 19px 23px !important; border: 2px solid; display: inline-block; text-decoration: none; text-transform: uppercase; -webkit-appearance: none !important; -moz-appearance: none !important; appearance: none !important; } .hbspt-form textarea{max-width: 100% !important; height: 186px !important; resize: none;} .hbspt-form textarea:focus{border: 1px solid #74cbc8 !important;} .hs-fieldtype-textarea .invalid.error{border: 2px solid #E74949 !important;} .hbspt-form fieldset{max-width: 100% !important; margin-bottom: 60px;} .hbspt-form .field {margin-bottom: 27px} .hs_recaptcha{ margin-top: 23px !important; margin-bottom: 27px !important; } .hs-button, .hs-form-field input[type=text], .hs-form-field input[type=email], .hs-form-field input[type=phone], .hs-form-field input[type=number], .hs-form-field input[type=tel], .hs-form-field input[type=date], .hs-form-field textarea { appearance: none; -webkit-appearance: none; -moz-appearance: none; } .hs-default-font-element, .hs-main-font-element { font-family: "Roboto Slab", helvetica, arial, sans-serif; } .hbspt-form .hs-button { white-space: pre-wrap } .hbspt-form .hs-richtext { word-break: break-word } .hbspt-form.submitted-message { overflow: auto } .hbspt-form fieldset.form-columns-1 .hs-input { width: 95% } .hbspt-form fieldset.form-columns-1 .input { margin-right: 0px !important } .hbspt-form fieldset.form-columns-1 input[type=checkbox], .hbspt-form fieldset.form-columns-1 input[type=radio] { width: auto } .hbspt-form fieldset.form-columns-2 .hs-form-field { width: 50%; float: left } .hbspt-form fieldset.form-columns-2 .input { margin-right: 0px !important; } .hbspt-form fieldset.form-columns-3 .hs-form-field { width: 32.7%; float: left } .hbspt-form fieldset.form-columns-3 .input { margin-right: 8px } .hbspt-form label.hs-hidden { visibility: hidden } .hbspt-form .hs-field-desc { width: 100% } .hs-custom-style .hs-input, .hs-custom-style fieldset { max-width: 100% } .hs-custom-style>div.form-columns-3 .hs-form-field, .hs-custom-style fieldset.form-columns-3 .hs-form-field { width: 33.3% } .hs-custom-style>div>div:last-of-type .hs-input:not([type=checkbox]):not([type=radio]), .hs-custom-style fieldset>div:last-of-type .hs-input:not([type=checkbox]):not([type=radio]) { width: 100%; max-width: 100% } .hs-custom-style>div input:not([type=image]):not([type=submit]):not([type=button]):not([type=radio]):not([type=checkbox]):not([type=file]), .hs-custom-style fieldset input:not([type=image]):not([type=submit]):not([type=button]):not([type=radio]):not([type=checkbox]):not([type=file]) { box-sizing: border-box; padding: 0 15px; min-height: 27px } .hs-custom-style>div textarea, .hs-custom-style fieldset textarea { padding: 10px 15px } .hs-custom-style .hs-dependent-field>div .hs-input:not([type=checkbox]):not([type=radio]) { width: 100% } .legal-consent-container .field.hs-form-field { margin-bottom: 8px } .legal-consent-container .hs-field-desc.checkbox-desc { margin: -12px 0 0 21px } .legal-consent-container .hs-form-booleancheckbox-display input { float: left } .legal-consent-container .hs-form-booleancheckbox-display>span { display: block !important; margin-left: 30px !important; } .legal-consent-container .hs-form-booleancheckbox-display p { margin: 0; display: inline } .legal-consent-container .hs-error-msgs label { color: #f2545b } .legal-consent-container~.hs_recaptcha { margin-top: 18px } .cookie-reset-container { font-size: 14px; margin-bottom: 10px; text-align: right } #hs-outer-captcha-target, #hs-outer-captcha-target * { display: none; height: 0; width: 0 } .hubspot-link__container { font-size: 14px; padding-bottom: 40px; position: relative; color: #9fa0a2; font-family: "Roboto Slab", helvetica, arial, sans-serif; } .hubspot-link-text { color: #00a4bd; font-weight: 400 } .hubspot-link__container.sproket { color: #9fa0a2 } .hubspot-link { color: #9fa0a2 } .hubspot-link, .hubspot-link:hover { text-decoration: none } .hubspot-link:hover .hubspot-link-text { text-decoration: underline } .hubspot-link__icon { margin-bottom: -1px; margin-right: 5px } .hubspot-link__container.sproket .hubspot-link__icon { width: 30px; margin-right: 0; float: left; margin-top: -9px; margin-left: -5px } .hubspot_signup_form .hs_email{margin-bottom: 0px !important; width: 80% !important; float: left !important;} .hubspot_signup_form .hs_submit{width: 20% !important; float: left !important; } .hubspot_signup_form .hs-button{padding: 12.5px 15px !important;} .hubspot_signup_form .hs_email label{display: none !important;} .hubspot_signup_form ul.no-list{position: absolute !important; top: 48px !important;} .hubspot_signup_form {position: relative !important;} .hubspot_signup_form .submitted-message{color: #ab8940 !important; font-size: 22px !important; } .hubspot_white .hbspt-form label, .hubspot_white .hs-form-required { color: #fff; } .hubspot_white .hs-input, .hubspot_white ul.inputs-list.multi-container li.hs-form-checkbox label span::before, .hubspot_white .hs-form-booleancheckbox-display span::before{ background-color: #fff !important; } .hubspot_white .hs_submit { text-align: center; } .hubspot_white .hs-form select.is-placeholder { opacity: 1; } .hubspot_white ul.inputs-list.multi-container li.hs-form-checkbox label span::after, .hubspot_white .hs-form-booleancheckbox-display span::after { border-color: #3f4852; } input[type=submit].hs-button.primary.large{ color: #fff; background: #00181e; border-color: #00181e !important; } input[type=submit].hs-button.primary.large:hover { background: #74cbc8 !important; border-color: #74cbc8 !important; } /***/ .hbspt-form .hs-input[type=checkbox]{ cursor: pointer; } .hs-form-booleancheckbox-display input:checked + span::after{ background: #fff; border-color: #157479; } .hbspt-form .form-columns-2 { display: flex; flex-flow: row wrap; -webkit-box-direction: normal; } .hbspt-form .hs_firstname { flex: 1; -webkit-box-flex: 1; } .hbspt-form .hs_submit{ margin-top: 60px; } .newsletter-form .hs_submit{margin-top: 45px;} .newsletter-form form .gfield_consent_description { border: none !important; } /*New Landing page*/ .landing-middle-section{ padding-right: 0px !important; } .left-col{max-width:93%} .left-col-para{padding-right:30px;} .left-col video{border-radius:4px;} /* Kit asssesment */ .kits_form_col .hbspt-form .hs-input[type=checkbox] { height: 20px !important; width: 20px !important; } .kits_form_col {padding-bottom: 45px;} .hs-richtext h4 {margin-bottom: 15px !important;} .kits_form_col label.hs-form-checkbox-display {margin-bottom: 15px;} .kits_form_col .hbspt-form li.hs-form-checkbox label span{ margin-left: 0px !important; padding-left: 31px; } .hbspt-form label.hs-form-radio-display { position: relative; padding: 4px 31px; } .hbspt-form .hs-form-radio-display span, .hbspt-form .hs-form-checkbox-display span { position: relative; cursor: pointer; font-size: 15px; font-weight: 300; } .hbspt-form .hs-input[type=radio] { position: absolute; left: 0; z-index: 2; width: 20px !important; height: 20px !important; outline: none; cursor: pointer; background-color: transparent !important; border-radius: 50%; } .hbspt-form .hs_protocol_synopsis_upload .input{position: relative;} .hbspt-form input[type="file"]::-webkit-file-upload-button { cursor: pointer; background-color: #157479; padding: 10px 20px !important; border: 1px solid #157479; border-top-left-radius: 0px; border-bottom-left-radius: 0px; border-top-right-radius: 6px; border-bottom-right-radius: 6px; color: #fff; position: absolute; top: 0; bottom: 0; right: 0; } .hbspt-form input[type="file"] { cursor: pointer; padding: 10px 20px !important; position: relative; top: 0; bottom: 0; right: 0; } /*Form Responsive CSS*/ @media only screen and (min-width: 1024px) and (max-width: 1366px){ .hs_email, .hs_contact_country { clear: both; } } @media only screen and (min-width: 992px) and (max-width: 1024px){ .hs_email, .hs_contact_country { clear: both; } } @media (min-width: 640px) and (max-width: 1120px) { .hbspt-form h1{font-size: 36px !important;} } @media screen and (min-width: 1120px) { .hbspt-form h1{font-size: 45px !important;margin-bottom: 17px !important;} .hbspt-form .gform_heading p{font-size: 17px !important;} } @media only screen and (min-width: 768px) and (max-width: 992px){ .hs_email, .hs_contact_country{ clear: both; } } @media (min-width: 767px) and (max-width: 1024px) { body .hubspot_signup_form .hs_email{width: 66% !important; float: left !important;} } @media screen and (max-width: 992px){ .assay-kit-hbspt-form .fl-col { width: 100%; } } @media screen and (max-width:812px){ .assay-kit-hbspt-form .fl-col { max-width: 100%; } .hbspt-form .hs-fieldtype-select .input:before{ right: 20px !important; } } @media screen and (max-width: 767px){ .hs_submit .actions{padding-top: 0px !important; margin-top: 0px !important;} body .hbspt-form fieldset.form-columns-2 .input {margin-right: 0px !important;} body fieldset.form-columns-3 .input{margin-right: 0px !important;} .hs-form-field .hs-input { width: 100% !important; } .hs-fieldtype-textarea .input{margin-right: 0px !important;} .hs_firstname, .hs_phone, .hs_development_area{ width: 100% !important; } } @media screen and (min-width: 640px){ .hbspt-form .hs_firstname, .kits_form_col .hs_email{ 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href="https://www.bioagilytix.com/"><i class="home-icon"></i><span class="screen-reader-text">Home</span></a></span> <span class="breadcrumb-separator"></span> <span><a href="https://www.bioagilytix.com/solutions/">Solutions</a></span> <span class="breadcrumb-separator"></span> <span><a href="https://www.bioagilytix.com/solutions/modalities/">Modalities</a></span> <span class="breadcrumb-separator"></span> <span class="breadcrumb_last" aria-current="page">Large Molecules</span></span></div></div></section><div class="wp-block-group alignwide is-layout-constrained wp-container-core-group-is-layout-1 wp-block-group-is-layout-constrained"><p class="has-text-align-center has-large-font-size">Large molecule or biologic drugs are a diverse class of compounds varying in size, complexity, and mode of action with broad therapeutic applications.  Due to this wide range of large molecule therapeutic types, bioanalytical support for these drugs requires a CRO provider with a comprehensive depth of expertise across therapeutic modalities and a large selection of bioanalytical tools or resources.  </p></div><div id="block_f97d14839205c71e7b4016b2ab2f60a7" class="wp-block em-media-content em-mt--lg em-mb--lg alignfull"><div class="em-media-content__inner em-media-content__inner--media-right has-gray-xxl-background-color em-media-content__inner--content-has-padding"><div class="em-media-content__media em-media-content__media--right"> <img fetchpriority="high" decoding="async" src="https://www.bioagilytix.com/wp-content/uploads/2023/08/large-molecules-1380x776.jpg" alt="large molecules" class="object-fit--cover" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/large-molecules-1380x776.jpg 1380w, https://www.bioagilytix.com/wp-content/uploads/2023/08/large-molecules-300x169.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/large-molecules-1024x576.jpg 1024w, https://www.bioagilytix.com/wp-content/uploads/2023/08/large-molecules-768x432.jpg 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/large-molecules-1536x864.jpg 1536w, https://www.bioagilytix.com/wp-content/uploads/2023/08/large-molecules-2048x1152.jpg 2048w, https://www.bioagilytix.com/wp-content/uploads/2023/08/large-molecules-2000x1125.jpg 2000w, https://www.bioagilytix.com/wp-content/uploads/2023/08/large-molecules-1120x630.jpg 1120w, https://www.bioagilytix.com/wp-content/uploads/2023/08/large-molecules-850x478.jpg 850w, https://www.bioagilytix.com/wp-content/uploads/2023/08/large-molecules-640x360.jpg 640w, https://www.bioagilytix.com/wp-content/uploads/2023/08/large-molecules-100x56.jpg 100w" width="1380" height="776"></div><div class="em-media-content__content em-media-content__content--left em-media-content__content--add-padding"><h2 class="h2">Our experience in the large molecule space</h2><p class="">BioAgilytix has a long history of supporting assays for large molecule therapeutics.  In fact, our experienced scientific team has provided bioanalytical testing for more than a third of the biologics that were approved by the US FDA between 2018 and 2023.  Our expertise spans a wide range of large molecule modalities including: </p><ul class="wp-block-list"><li class=""><a href="https://go.bioagilytix.com/biosimilar">Biosimilars</a>聽</li><li class=""><a href="https://go.bioagilytix.com/antibody-drug-conjugate-testing">ADC</a>聽</li><li class=""><a href="https://go.bioagilytix.com/monoclonal-antibodies-testing-services">Monoclonal antibodies</a>聽</li><li class="">Bi-specific/tri-specific proteins </li><li class="">Enzyme replacements </li><li class="">Recombinant proteins </li><li class=""><a href="https://www.bioagilytix.com/solutions/capabilities/off-the-shelf-assay-menu/">Off-the-shelf assay menu</a></li></ul></div></div></div><div class="wp-block-emagine-background alignfull has-em-white-background-color has-background-dim em-pt--md em-pb--xs em-mt--md em-mb--none"><div class="wp-block-emagine-background__content"><div class="wp-block-emagine-background__content-inner"><div class="wp-block-group is-content-justification-left is-layout-constrained wp-container-core-group-is-layout-2 wp-block-group-is-layout-constrained"><h2 class="has-text-align-left h2">BioAnalytical services for each drug development phase</h2><p class="has-text-align-left">Our established regulatory infrastructure allows us to provide compliant assays across all stages of drug development including non-regulated, GLP, GCLP, and GMP.  We have multiple global locations and maintain SOPs that are consistent for regulatory authorities around the world.  Our flexibility and established procedures ensure that we can work with our clients to provide bioanalytical solutions through the full life cycle of their therapeutic programs.  We offer a full suite of bioanalytical services for every regulatory stage including: </p></div><div class="wp-block-emagine-spacer wp-block-emagine-spacer--md" aria-hidden="true"></div><div 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its efficacy and safety. PK evaluations help to define the proper dosage, route, and schedule of administration during preclinical and clinical studies.</p><div class="wp-block-emagine-buttons has-text-align-left"><div class="wp-block-emagine-button has-text-align-left is-style-arrow-right em-mt--md"><a class="btn btn--size-md btn--style-primary has-quaternary-background-color" href="https://www.bioagilytix.com/solutions/bioanalytical-laboratory-services/pk-assay/" rel=""><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div></div><div id="em-tabpanel-674089c65d9c9" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-674089c65d9c9-control" > <button id="em-tabpanel-674089c65d9c9-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-674089c65d9c9" tabindex="-1" > <span class="em-tab-control__icon"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="56px" height="60.0000463px" 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class="em-tab-control__text">Pharmacodynamics (PD)聽</span> </button><div class="em-tabpanel__inner has-none-background-color"><div class="em-tabpanel__content em-pt--default em-pr--default em-pb--default em-pl--default"><h3 class="h3 em-mt--none">Pharmacodynamics (PD) </h3><p class="">PD assessments in early drug development studies can provide vital information on biological effects to help the design of later clinical studies to improve treatment. PD biomarkers are used in preclinical and clinical studies for establishing dosing regimens and therapeutic efficacy.</p><div class="wp-block-emagine-buttons has-text-align-left"><div class="wp-block-emagine-button has-text-align-left is-style-arrow-right em-mt--md"><a class="btn btn--size-md btn--style-primary has-quaternary-background-color" href="https://www.bioagilytix.com/solutions/bioanalytical-laboratory-services/pd-assay/" rel=""><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div></div><div id="em-tabpanel-674089c65e349" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-674089c65e349-control" > <button id="em-tabpanel-674089c65e349-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-674089c65e349" tabindex="-1" > <span class="em-tab-control__icon"> <svg xmlns="http://www.w3.org/2000/svg" id="674089c65e503-Layer_2" viewBox="0 0 1010 923.3" width="1010px" height="923.3px" class=""><defs><style>.cls-1{fill:#131719;}</style></defs><g id="674089c65e503-Layer_1-2"><path class="cls-1" d="m978.03,186.45l-122.64,122.64c-4.92,4.92-11.47,7.64-18.43,7.64s-13.51-2.71-18.43-7.64c-4.92-4.92-7.63-11.47-7.63-18.43s2.71-13.51,7.63-18.43l11.68-11.68c3.69-3.69,5.94-8.26,6.77-13.03,4.9-.85,9.46-3.2,13.03-6.77l91.16-91.15c4.92-4.92,11.47-7.64,18.43-7.64s13.51,2.71,18.43,7.64c4.92,4.92,7.63,11.47,7.63,18.43s-2.71,13.51-7.64,18.43h0Zm-215.54-13.43c-4.91.85-9.46,3.2-13.03,6.77l-130.05,130.05c-4.56,4.56-7.13,10.75-7.13,17.21v545.84c0,14.37-11.69,26.07-26.07,26.07s-26.07-11.69-26.07-26.07v-438.25c0-5.21-1.64-10.04-4.43-14,2.79-3.96,4.43-8.79,4.43-14v-103.01c0-5.62,2.19-10.89,6.16-14.86L823.55,31.97c4.92-4.92,11.47-7.64,18.43-7.64,6.97,0,13.51,2.71,18.44,7.64,10.16,10.16,10.16,26.7,0,36.87l-91.15,91.15c-3.69,3.69-5.94,8.26-6.77,13.03h0Zm-312.63,261.61v438.25c0,14.37-11.69,26.07-26.07,26.07s-26.07-11.69-26.07-26.07V327.06c0-6.46-2.56-12.65-7.13-17.21l-128.07-128.07c-3.57-3.57-8.13-5.91-13.03-6.77-.83-4.77-3.08-9.35-6.77-13.03l-93.13-93.13c-10.16-10.16-10.16-26.7,0-36.87,4.92-4.92,11.47-7.64,18.43-7.64s13.51,2.71,18.45,7.65l260.3,259.84c1.99,1.99,3.09,4.63,3.09,7.45v107.36c0,5.21,1.64,10.04,4.43,14-2.79,3.96-4.43,8.79-4.43,14h0Zm-250.74-143.98c0,6.96-2.71,13.51-7.64,18.43-4.92,4.92-11.47,7.64-18.43,7.64s-13.51-2.71-18.43-7.64L31.97,186.45c-4.92-4.92-7.64-11.47-7.64-18.43s2.71-13.51,7.64-18.43c4.92-4.92,11.47-7.64,18.43-7.64s13.51,2.71,18.43,7.64l93.13,93.13c3.57,3.57,8.13,5.91,13.03,6.77.85,4.91,3.2,9.47,6.77,13.04l9.71,9.71c4.92,4.92,7.64,11.47,7.64,18.43h0Zm796.12-158.28c-9.84-9.84-22.74-14.76-35.64-14.76s-25.8,4.92-35.64,14.76l-91.16,91.15-46.33-46.33,91.15-91.15c19.69-19.69,19.69-51.6,0-71.29h0C867.78,4.92,854.88,0,841.98,0c-12.9,0-25.8,4.92-35.64,14.76l-257.23,256.77c-8.52,8.5-13.31,20.05-13.31,32.09v103.01h-61.61v-107.36c0-9.26-3.68-18.13-10.23-24.67L203.66,14.76C193.82,4.92,180.92,0,168.02,0s-25.8,4.92-35.64,14.76h0c-19.69,19.69-19.69,51.6,0,71.29l93.13,93.13-46.33,46.33-93.13-93.13c-9.84-9.84-22.74-14.76-35.64-14.76s-25.8,4.92-35.64,14.76c-19.69,19.68-19.69,51.6,0,71.28l122.64,122.64c9.84,9.84,22.74,14.76,35.64,14.76s25.8-4.92,35.64-14.76c19.69-19.69,19.69-51.6,0-71.29l-9.71-9.71,46.33-46.33,128.07,128.07v545.84c0,27.84,22.57,50.41,50.41,50.41s50.41-22.57,50.41-50.41v-438.25h61.61v438.25c0,27.84,22.57,50.41,50.41,50.41s50.41-22.57,50.41-50.41V327.06l130.05-130.05,46.33,46.33-11.68,11.68c-19.69,19.69-19.69,51.6,0,71.29,9.84,9.84,22.74,14.76,35.64,14.76s25.8-4.92,35.64-14.76l122.64-122.64c19.69-19.68,19.69-51.6,0-71.28h0Z"></path></g></svg> </span> <span class="em-tab-control__text">Immunogenicity</span> </button><div class="em-tabpanel__inner has-none-background-color"><div class="em-tabpanel__content em-pt--default em-pr--default em-pb--default em-pl--default"><h3 class="h3 em-mt--none">Immunogenicity   </h3><p class="">Immunogenicity risk assessment is critical to the development of most therapeutic modalities. It can affect both safety and efficacy, ranging from no evidence of clinical effect to severe, life-threatening responses. Assessment of undesirable immunogenicity of therapeutics is a key element in drug development.</p><div class="wp-block-emagine-buttons has-text-align-left"><div class="wp-block-emagine-button has-text-align-left is-style-arrow-right em-mt--md"><a class="btn btn--size-md btn--style-primary has-quaternary-background-color" href="https://www.bioagilytix.com/solutions/bioanalytical-laboratory-services/immunogenicity-assay/" rel=""><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div></div><div id="em-tabpanel-674089c65eb28" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-674089c65eb28-control" > <button id="em-tabpanel-674089c65eb28-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-674089c65eb28" tabindex="-1" > <span class="em-tab-control__icon"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="59.9957188px" height="60px" viewBox="0 0 59.9957188 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Biomarker assays can also validate targets and identify potential toxicity.</p><div class="wp-block-emagine-buttons has-text-align-left"><div class="wp-block-emagine-button has-text-align-left is-style-arrow-right em-mt--md"><a class="btn btn--size-md btn--style-primary has-quaternary-background-color" href="https://www.bioagilytix.com/solutions/bioanalytical-laboratory-services/biomarker-testing/" rel=""><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div></div><div id="em-tabpanel-674089c65f44c" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-674089c65f44c-control" > <button id="em-tabpanel-674089c65f44c-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-674089c65f44c" tabindex="-1" > <span class="em-tab-control__icon"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="60px" height="60px" viewBox="0 0 60 60" version="1.1" class=""><title>013 – Computer Molecules</title> <desc>Created with Sketch.</desc> <defs></defs> <g id="674089c65f649-Page-1" stroke="none" stroke-width="1" fill="none" fill-rule="evenodd"> <g id="674089c65f649-013---Computer-Molecules" transform="translate(-1.000000, 0.000000)" fill="#000000" fill-rule="nonzero"> <path d="M58,0 L4,0 C2.29475828,0.0544156318 0.954002644,1.47651044 1,3.182 L1,46.818 C0.954002644,48.5234896 2.29475828,49.9455844 4,50 L21.382,50 L19.382,54 L16,54 C14.3431458,54 13,55.3431458 13,57 C13,58.6568542 14.3431458,60 16,60 L46,60 C47.6568542,60 49,58.6568542 49,57 C49,55.3431458 47.6568542,54 46,54 L42.618,54 L40.618,50 L58,50 C59.7052417,49.9455844 61.0459974,48.5234896 61,46.818 L61,3.182 C61.0459974,1.47651044 59.7052417,0.0544156318 58,0 Z M4,2 L58,2 C58.5966179,2.06161524 59.038076,2.58341866 59,3.182 L59,42 L3,42 L3,3.182 C2.96192401,2.58341866 3.40338206,2.06161524 4,2 Z M47,57 C47,57.5522847 46.5522847,58 46,58 L16,58 C15.4477153,58 15,57.5522847 15,57 C15,56.4477153 15.4477153,56 16,56 L46,56 C46.5522847,56 47,56.4477153 47,57 Z M40.382,54 L21.618,54 L23.618,50 L38.382,50 L40.382,54 Z M58,48 L4,48 C3.40338206,47.9383848 2.96192401,47.4165813 3,46.818 L3,44 L59,44 L59,46.818 C59.038076,47.4165813 58.5966179,47.9383848 58,48 Z" id="674089c65f649-Shape"></path> <path d="M7.971,27.149 L12,29.566 L12,34.434 C12.0021653,35.135955 12.3701979,35.7859816 12.971,36.149 L16.971,38.549 C17.604369,38.9290257 18.395631,38.9290257 19.029,38.549 L23.044,36.14 L26.553,37.9 C27.0472949,38.1468713 27.6481287,37.9462949 27.895,37.452 C28.1418713,36.9577051 27.9412949,36.3568713 27.447,36.11 L24,34.382 L24,29.566 C23.9978347,28.864045 23.6298021,28.2140184 23.029,27.851 L19,25.434 L19,20.534 L24.028,17.182 L28,19.566 L28,24.434 C28.0021653,25.135955 28.3701979,25.7859816 28.971,26.149 L32.971,28.549 C33.604369,28.9290257 34.395631,28.9290257 35.029,28.549 L38.918,26.215 L43,29.48 L43,34.434 C43.0021653,35.135955 43.3701979,35.7859816 43.971,36.149 L47.971,38.549 C48.604369,38.9290257 49.395631,38.9290257 50.029,38.549 L54.029,36.149 C54.6299476,35.7861231 54.9980308,35.136007 55,34.434 L55,29.566 C54.9978347,28.864045 54.6298021,28.2140184 54.029,27.851 L50.029,25.451 C49.395631,25.0709743 48.604369,25.0709743 47.971,25.451 L44.082,27.785 L40,24.52 L40,19.468 L45.64,14.768 C46.0486317,14.4105117 46.0973621,13.7922738 45.749784,13.37518 C45.4022058,12.9580863 44.7853155,12.8945322 44.36,13.232 L38.906,17.777 L35,15.434 L35,10.566 C34.9978347,9.86404497 34.6298021,9.21401839 34.029,8.851 L30.029,6.451 C29.395631,6.07097434 28.604369,6.07097434 27.971,6.451 L23.971,8.851 C23.3700524,9.21387692 23.0019692,9.86399298 23,10.566 L23,15.466 L17.972,18.818 L14,16.434 L14,13 C14,12.4477153 13.5522847,12 13,12 C12.4477153,12 12,12.4477153 12,13 L12,16.434 L7.97,18.852 C7.3697397,19.2149376 7.00210595,19.8645503 7,20.566 L7,25.434 C7.00216533,26.135955 7.37019787,26.7859816 7.971,27.149 Z M23,29.566 L22,29.566 L22,34.434 L18,36.834 L14,34.434 L14,29.566 L16,28.366 L18,27.166 L22,29.566 L23,29.566 Z M45,29.566 L49,27.166 L53,29.566 L53,34.434 L49,36.834 L45,34.434 L45,29.566 Z M38,24.434 L34,26.834 L30,24.434 L30,19.566 L32,18.366 L34,17.166 L38,19.566 L38,24.434 Z M25,10.566 L29,8.166 L33,10.566 L33,15.434 L31,16.634 L29,17.834 L25,15.434 L25,10.566 Z M9,20.566 L13,18.166 L17,20.566 L17,25.434 L15,26.634 L13,27.834 L9,25.434 L9,20.566 Z"></path> </g> </g> </svg> </span> <span class="em-tab-control__text">CMC Bioanalytical</span> </button><div class="em-tabpanel__inner has-none-background-color"><div class="em-tabpanel__content em-pt--default em-pr--default em-pb--default em-pl--default"><h3 class="h3 em-mt--none">CMC Bioanalytical    </h3><p class="">CMC bioanalytical testing is required for all drug development programs. These assays are used to monitor the drug manufacturing processes and ensure the safety, efficacy, and quality of pharmaceutical products. CMC bioanalytical strategies are inherently complex and must be individualized for each therapeutic program.</p><div class="wp-block-emagine-buttons has-text-align-left"><div class="wp-block-emagine-button has-text-align-left is-style-arrow-right em-mt--md"><a class="btn btn--size-md btn--style-primary has-quaternary-background-color" href="https://www.bioagilytix.com/solutions/bioanalytical-laboratory-services/cmc-analytical-development/" rel=""><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div></div><div id="em-tabpanel-674089c65fa4f" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-674089c65fa4f-control" > <button id="em-tabpanel-674089c65fa4f-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-674089c65fa4f" tabindex="-1" > <span class="em-tab-control__icon"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="60px" height="60px" viewBox="0 0 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</button><div class="em-tabpanel__inner has-none-background-color"><div class="em-tabpanel__content em-pt--default em-pr--default em-pb--default em-pl--default"><h3 class="h3 em-mt--none">Diagnostic Testing     </h3><p class="">When you need a dependable diagnostic testing laboratory partner who consistently delivers reliable testing results on time, choose BioAgilytix Diagnostics. If tailored testing and responsive service matter to you, BioAgilytix Diagnostics should be your provider of choice.</p><div class="wp-block-emagine-buttons has-text-align-left"><div class="wp-block-emagine-button has-text-align-left is-style-arrow-right em-mt--md"><a class="btn btn--size-md btn--style-primary has-quaternary-background-color" href="https://www.bioagilytix.com/solutions/capabilities/diagnostic-testing/" rel=""><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div></div></div></div></div></div></div></div><div class="wp-block-emagine-background alignfull has-gray-xxl-background-color has-background-dim em-mt--lg"><div class="wp-block-emagine-background__content"><div class="wp-block-emagine-background__content-inner"></div></div></div><div class="wp-block-emagine-grid alignfull wp-block-emagine-grid--halves em-mt--none em-mb--none"><div class="wp-block-emagine-grid__inner em-grid-2_sm-1-smGutter-equalHeight-left"><div class="wp-block-emagine-column em-col"><div id="block_86f4adaa7bbf4cf5c2929383a9598b80" class="wp-block em-call-to-action alignfull"><div class="em-call-to-action--align-center has-black-background-color has-background-opacity--60 em-pt--lg em-pb--lg em-pl--md em-pr--md"><div class="em-call-to-action__background"> <picture> <source data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/06/masthead-sample-850x478.jpg" media="(max-width: 850px)"> <source data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/06/masthead-sample-1120x630.jpg" media="(max-width: 1124px)"> <noscript><img decoding="async" class="object-fit-cover" src="https://www.bioagilytix.com/wp-content/uploads/2023/06/masthead-sample-1380x719.jpg" alt="test tube samples"></noscript><img decoding="async" class="lazyload object-fit-cover" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%20210%20140%22%3E%3C/svg%3E' data-src="https://www.bioagilytix.com/wp-content/uploads/2023/06/masthead-sample-1380x719.jpg" alt="test tube samples"> </picture></div><div class="em-call-to-action__inner"><h2 class="has-em-white-color has-text-color has-text-align-center h2">Biosimilars</h2><p class="has-text-align-center has-em-white-color has-text-color">Rely on the combined power of BioAgilytix鈥檚 scientists, advanced platforms, and validated techniques to quickly progress the development of your promising biosimilars. Our scientists have experience supporting biosimilar studies with a number of assays for generics, including ligand binding assays, characterization, and stability testing on multiple platforms.</p><div class="wp-block-emagine-buttons has-text-align-center"><div class="wp-block-emagine-button has-text-align-left"><a class="btn btn--size-md btn--style-outline has-em-white-background-color" href="https://www.bioagilytix.com/solutions/modalities/large-molecule-bioanalysis-testing/biosimilar-testing-services/" rel=""><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div></div></div><div class="wp-block-emagine-column em-col"><div id="block_0860253d3418cc29646f8ff8e1f1e548" class="wp-block em-call-to-action alignfull"><div class="em-call-to-action--align-center has-black-background-color has-background-opacity--60 em-pt--lg em-pb--lg em-pl--md em-pr--md"><div class="em-call-to-action__background"> <picture> <source data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/06/iStock-1354171846-850x478.jpg" media="(max-width: 850px)"> <source data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/06/iStock-1354171846-1120x630.jpg" media="(max-width: 1124px)"> <noscript><img decoding="async" class="object-fit-cover" src="https://www.bioagilytix.com/wp-content/uploads/2023/06/iStock-1354171846-1380x776.jpg" alt="two male scientist looking at petri dish"></noscript><img decoding="async" class="lazyload object-fit-cover" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%20210%20140%22%3E%3C/svg%3E' data-src="https://www.bioagilytix.com/wp-content/uploads/2023/06/iStock-1354171846-1380x776.jpg" alt="two male scientist looking at petri dish"> </picture></div><div class="em-call-to-action__inner"><h2 class="has-em-white-color has-text-color has-text-align-center h2">ADC Testing</h2><p class="has-text-align-center has-em-white-color has-text-color">Antibody drug conjugates (ADCs) continue to show significant therapeutic promise, and BioAgilytix is here to help support their development for life-changing outcomes. We have been supporting customers at the leading edge with expert antibody drug conjugate testing services, and will apply that first-hand expertise to your distinct project requirements.</p><div class="wp-block-emagine-buttons has-text-align-center"><div class="wp-block-emagine-button has-text-align-left"><a class="btn btn--size-md btn--style-outline has-em-white-background-color" href="https://www.bioagilytix.com/solutions/modalities/large-molecule-bioanalysis-testing/antibody-drug-conjugate-testing/" target="_self" rel="noopener"><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div></div></div></div></div><div class="wp-block-emagine-background alignfull has-primary-d-background-color has-background-dim em-pt--lg em-pb--md em-mt--xs"><div class="wp-block-emagine-background__content"><div class="wp-block-emagine-background__content-inner"><div class="wp-block-emagine-grid alignwide wp-block-emagine-grid--halves"><div class="wp-block-emagine-grid__inner em-grid-2_sm-1-left-middle"><div class="wp-block-emagine-column em-col-middle"><div class="wp-block-image size-large"><div><figure class=""><noscript><img decoding="async" width="1024" height="683" src="https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1-1024x683.jpg" alt="" class="wp-image-5348" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1-1024x683.jpg 1024w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1-300x200.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1-768x512.jpg 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1-1536x1025.jpg 1536w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1-100x67.jpg 100w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1.jpg 2000w" sizes="(max-width: 1024px) 100vw, 1024px" /></noscript><img decoding="async" width="1024" height="683" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%201024%20683%22%3E%3C/svg%3E' data-src="https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1-1024x683.jpg" alt="" class="lazyload wp-image-5348" data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1-1024x683.jpg 1024w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1-300x200.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1-768x512.jpg 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1-1536x1025.jpg 1536w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1-100x67.jpg 100w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-915276808-1.jpg 2000w" data-sizes="(max-width: 1024px) 100vw, 1024px" /></figure></div></div></div><div class="wp-block-emagine-column em-col-middle"><h2 class="has-em-white-color has-text-color h2">End-to-end support</h2><p class="">BioAgilytix is able to build sustainable, long-term partnerships with our clients due to our ability to provide bioanalytical solutions at any stage of the drug development process, from start to finish.  We focus on maintaining a wide selection of instrumentation and a robust regulatory infrastructure in order to provide competitive service offerings for all the various large molecule therapeutic modalities. BioAgilytix鈥檚 commitment to delivering high quality data across each of our programs combined with our depth of expertise in large molecule bioanalysis means we can ensure that we deliver critical data to support successful large molecule programs.   </p></div></div></div></div></div></div><div id="block_4ea9fce3d950494d3bb6cfe76329804f" class="wp-block em-media-content em-mt--md em-mb--lg alignwide"><div class="em-media-content__inner em-media-content__inner--media-right has-none-background-color em-media-content__inner--content-has-padding"><div class="em-media-content__media em-media-content__media--right"> <noscript><img decoding="async" src="https://www.bioagilytix.com/wp-content/uploads/2023/08/eilsa-machine.jpg" alt="lab worker at his computer" class="object-fit--cover" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/eilsa-machine.jpg 1200w, https://www.bioagilytix.com/wp-content/uploads/2023/08/eilsa-machine-150x150.jpg 150w, https://www.bioagilytix.com/wp-content/uploads/2023/08/eilsa-machine-300x300.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/eilsa-machine-600x600.jpg 600w" width="1200" height="1200"></noscript><img decoding="async" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%201200%201200%22%3E%3C/svg%3E' data-src="https://www.bioagilytix.com/wp-content/uploads/2023/08/eilsa-machine.jpg" alt="lab worker at his computer" class="lazyload object-fit--cover" data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/eilsa-machine.jpg 1200w, https://www.bioagilytix.com/wp-content/uploads/2023/08/eilsa-machine-150x150.jpg 150w, https://www.bioagilytix.com/wp-content/uploads/2023/08/eilsa-machine-300x300.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/eilsa-machine-600x600.jpg 600w" width="1200" height="1200"></div><div class="em-media-content__content em-media-content__content--left em-media-content__content--add-padding"><h2 class="h2">Equipment and software for dose formulation analysis</h2><p class="">BioAgilytix has invested in new UPLC systems for dose formulation analysis and built out a separate lab space to isolate these high concentration samples from the sub nanogram level bioanalytical samples. The new UPLC systems have UV/VIS, diode array, CAD (Charged Aerosol Detection), and fluorescence detection capabilities.</p><div class="wp-block-emagine-button has-text-align-left em-mt--md"><a class="btn btn--size-md btn--style-outline has-quaternary-background-color" href="https://www.bioagilytix.com/company/about-bioagilytix/equipment/" rel=""><span>See our Instrumentation <span class="btn__last-word">List</span></span></a></div></div></div></div><div id="block_cdce98d9f49f3cbfbc6e490c655c3c0f" class="wp-block em-call-to-action em-mb--none alignfull"><div class="em-call-to-action--align-center has-primary-l-background-color has-background-opacity-- em-pt--lg em-pb--lg em-pl--md em-pr--md"><div class="em-call-to-action__inner"><p class="">Case Study</p><h2 class="h2">Simultaneous determination of drug concentrations</h2><p class="has-medium-font-size">Learn how the development of a novel extraction and derivatization scheme allowed us to simultaneously determine free and covalently bound drug concentrations using a single assay.</p><div class="wp-block-emagine-button has-text-align-left is-style-arrow-right"><a class="btn btn--size-md btn--style-primary has-quaternary-background-color" href="https://www.bioagilytix.com/scientific-expertise/scientific-insights/simultaneous-determination-of-drug-concentrations/" rel=""><span>Read Case <span class="btn__last-word">STudy</span></span></a></div></div></div></div></article></main><footer class="site-footer site-footer--has-logo site-footer--align-brand-left"><div class="deep-footer clearfix"><div class="alignwide"><div class="em-grid"><div class="em-col-6_md-12"><div class="deep-footer__brand"><div class="deep-footer__logo" style="max-width: 300px"> <a href="https://www.bioagilytix.com"><div class="em-image"><div class="em-image__ratio" style="padding-top:21.420572708367%;"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 187.53 40.17" width="187.53px" height="40.17px" class=""><g fill="none"><g fill="#fff"><path 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