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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">Advanced Therapies (ATMP)</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">Advanced Therapy Medicinal Products (ATMPs) are a novel area of therapeutics that includes many groundbreaking approaches to medical intervention for disease.  Bioanalytical testing of ATMPs for safety and efficacy is an evolving field as the body of data on these modalities continues to grow.</p></div><div id="block_f3838bfd177bbade0300a2c07d8c7505" class="wp-block em-media-content em-mt--lg em-mb--lg alignfull"><div class="em-media-content__inner em-media-content__inner--media-left has-gray-xxl-background-color em-media-content__inner--content-has-padding"><div class="em-media-content__media em-media-content__media--left"> <img fetchpriority="high" decoding="async" src="https://www.bioagilytix.com/wp-content/uploads/2023/07/Virology-Lab-1-1380x776.jpg" alt="Virology Lab" class="object-fit--cover" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/07/Virology-Lab-1-1380x776.jpg 1380w, https://www.bioagilytix.com/wp-content/uploads/2023/07/Virology-Lab-1-2000x1125.jpg 2000w, https://www.bioagilytix.com/wp-content/uploads/2023/07/Virology-Lab-1-1120x630.jpg 1120w, https://www.bioagilytix.com/wp-content/uploads/2023/07/Virology-Lab-1-850x478.jpg 850w, https://www.bioagilytix.com/wp-content/uploads/2023/07/Virology-Lab-1-640x360.jpg 640w" width="1380" height="776"></div><div class="em-media-content__content em-media-content__content--right em-media-content__content--add-padding"><h2 class="h2"><strong>Tailored strategies for ATMP bioanalytical support  </strong></h2><p class="">ATMP is a general term which encompasses a number of discrete therapeutic modalities that are of biological origin including genes, somatic cells, or engineered tissues. These therapeutics can be applied to a wide range of indications from neurologic diseases such as Alzheimers to oncologic diseases such as lymphoma. Common subcategories for these drugs include: </p><ul class="wp-block-list"><li class=""><a href="https://www.bioagilytix.com/solutions/modalities/atmp-bioanalysis/cell-therapy-products-bioanalysis/">Cell therapy</a> </li><li class=""><a href="https://go.bioagilytix.com/gene-therapy-bioanalysis">Gene therapy</a>聽</li><li class=""><a href="https://www.bioagilytix.com/solutions/modalities/atmp-bioanalysis/car-t-cell-therapies/">CAR cell therapy</a> </li><li class=""><a href="https://go.bioagilytix.com/rna-therapy-bioanalysis">RNA-based therapy聽</a></li><li class=""><a href="https://go.bioagilytix.com/rna-therapy-bioanalysis">Oligonucleotide therapy聽</a></li><li class="">Stem cell therapy  </li></ul></div></div></div><div class="wp-block-emagine-background alignfull has-em-white-background-color has-background-dim em-mt--xl"><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"><strong>Diverse assay types for ATMP testing</strong></h2><p class="has-text-align-left">Each of these modalities requires a unique strategy for bioanalytical support.  At BioAgilytix, we have made significant investments to our instrumentation and scientific expertise over the years to ensure that we are able to offer high-quality, tailored services to meet these demands.  Our molecular capabilities, including ddPCR and qPCR, and our cellular immunogenicity capabilities, including ELISpot and flow cytometry, are key components for a strong bioanalytical testing program for ATMPs.  Combined with the more traditional methodologies we offer such as immunoassays and mass spectrometry, BioAgilytix is able to provide customized approaches for a comprehensive service package to support your ATMP bioanalytical needs.  Here are a few examples of how we are applying these methodologies to some of our specialized ATMP service offerings: </p></div><div class="wp-block-emagine-spacer wp-block-emagine-spacer--md" aria-hidden="true"></div><div id="block_631506d590dff85507de3cd6fd7cbab1" class="wp-block em-tabs is-style-vertical alignwide"><div class="em-tabs__inner"><div class="em-tabs__tablist" role="tablist"></div><div class="em-tabs__tabpanels"><div id="em-tabpanel-674093a46ba7f" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-674093a46ba7f-control" > <button id="em-tabpanel-674093a46ba7f-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-674093a46ba7f" 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>069 – Virus Dish</title> <desc>Created with Sketch.</desc> <defs></defs> <g id="674093a46be89-Page-1" stroke="none" 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C31.2916299,13.8100678 31.0253068,14.8047519 31,15.82 L31,16.14 C30.9998621,16.6371501 31.3649593,17.0589076 31.857,17.13 C34.0093267,17.4413637 36.0492085,18.2875038 37.79,19.591 C38.1971077,19.8861579 38.7587334,19.8398514 39.112,19.482 C39.8908699,18.6510899 40.4813026,17.661919 40.843,16.582 C40.9479181,16.3101016 41.1094966,16.0636433 41.317,15.859 C41.7399245,15.4371813 42.3292526,15.2264765 42.9237487,15.2845328 C43.5182449,15.3425891 44.0556741,15.6633287 44.389,16.159 C44.8424313,16.8412422 44.8396675,17.7295923 44.382,18.409 C44.1272811,18.7673168 43.7656759,19.0358078 43.349,19.176 C42.3663291,19.4576197 41.4672904,19.974936 40.73,20.683 L40.501,20.913 C40.1500126,21.2649665 40.1108219,21.8213036 40.409,22.219 C41.7115221,23.9565893 42.557647,25.9929965 42.87,28.142 C42.9456444,28.6355938 43.3706441,28.9998186 43.87,28.999 C45.0111794,28.9603502 46.131453,28.6819854 47.158,28.182 C47.9834376,27.8131205 48.9532339,28.0321592 49.54,28.72 L49.54,28.718 Z"></path> <path d="M36,24 C36,21.790861 34.209139,20 32,20 C29.790861,20 28,21.790861 28,24 C28,24.5522847 28.4477153,25 29,25 C29.5522847,25 30,24.5522847 30,24 C30,22.8954305 30.8954305,22 32,22 C33.1045695,22 34,22.8954305 34,24 C34,25.1045695 33.1045695,26 32,26 C31.4477153,26 31,26.4477153 31,27 C31,27.5522847 31.4477153,28 32,28 C34.209139,28 36,26.209139 36,24 Z"></path> <path d="M27.148,31.02 C26.6067837,30.9107637 26.0794506,31.260827 25.97,31.802 C25.8111432,32.5748662 25.0806953,33.0925391 24.2988498,32.9863545 C23.5170043,32.8801698 22.9510813,32.186433 23.004107,31.3991936 C23.0571326,30.6119542 23.7109769,30.0003766 24.5,30 C25.0522847,30 25.5,29.5522847 25.5,29 C25.5,28.4477153 25.0522847,28 24.5,28 C22.6583401,28.0009021 21.1324369,29.428845 21.0095188,31.2663986 C20.8866006,33.1039522 22.2087233,34.7224061 24.0338552,34.9685883 C25.858987,35.2147705 27.5626678,34.004451 27.931,32.2 C27.984025,31.9396529 27.9312632,31.6689067 27.7843604,31.4475206 C27.6374576,31.2261345 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flow cytometry) </li><li class="">Cellular kinetics (PCR or flow cytometry) </li><li class="">Immune phenotyping (flow cytometry) </li><li class="">Cytokine analysis including cytokine response syndrome monitoring (MSD, luminex) </li></ul><div class="wp-block-emagine-buttons has-text-align-left"><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/solutions/modalities/atmp-bioanalysis/car-t-cell-therapies/" rel=""><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div></div><div id="em-tabpanel-674093a46c320" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-674093a46c320-control" > <button id="em-tabpanel-674093a46c320-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-674093a46c320" 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>67 -DNA- (science, laboratory, research, outline)</title> <desc>Created with Sketch.</desc> <defs></defs> <g id="674093a46c493-Page-1" stroke="none" stroke-width="1" fill="none" fill-rule="evenodd" stroke-linecap="round" stroke-linejoin="round"> <g id="674093a46c493-Icons" transform="translate(-840.000000, -1100.000000)" stroke="#000000" stroke-width="2"> <g id="674093a46c493-67--DNA--(science,--laboratory,-research,-outline)" transform="translate(841.000000, 1101.000000)"> <path d="M57.2843,16.2721 C52.3563,21.2001 47.7973,20.2201 39.6063,18.3931 C31.4163,16.5671 24.7423,17.7011 21.2213,21.2221 C17.7153,24.7281 17.9813,30.0021 19.8073,38.1921 C21.6343,46.3831 21.1633,52.3931 16.2723,57.2841" id="674093a46c493-Stroke-775"></path> <path d="M41.7279,0.7157 C36.7779,5.6657 37.7799,10.2027 39.6069,18.3937 C41.4329,26.5837 40.2839,33.2717 36.7779,36.7777 C33.2719,40.2847 27.9979,40.0187 19.8079,38.1927 C11.6169,36.3657 5.6069,36.8367 0.7159,41.7277" id="674093a46c493-Stroke-776"></path> <path d="M40.3989,2.2151 L55.7839,17.6001" id="674093a46c493-Stroke-777"></path> <path d="M38.1222,8.4237 L49.5692,19.8707" id="674093a46c493-Stroke-778"></path> <path d="M10.4063,37.2764 L20.7233,47.5934" id="674093a46c493-Stroke-779"></path> <path d="M3.0275,39.7971 L18.2025,54.9721" id="674093a46c493-Stroke-780"></path> <path d="M30.3341,17.6062 L40.3901,27.6622" id="674093a46c493-Stroke-781"></path> <path d="M21.9655,20.5513 L37.4485,36.0343" id="674093a46c493-Stroke-782"></path> <path d="M18.4977,28.3972 L29.6027,39.5022" id="674093a46c493-Stroke-783"></path> </g> </g> </g> </svg> </span> <span class="em-tab-control__text">Gene Therapies</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">Gene Therapies</h3><ul class="wp-block-list"><li class="">Vector and transgene anti-drug antibodies (ELISA, MSD) </li><li class="">Vector copy number (PCR) </li><li class="">Viral shedding and distribution (PCR) </li><li class="">Replication competent virus (PCR) </li></ul><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/solutions/modalities/atmp-bioanalysis/gene-therapy-bioanalysis/" rel=""><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div></div></div></div></div></div></div><div class="wp-block-emagine-background alignfull has-quaternary-background-color has-background-dim em-pt--md em-pb--md em-mb--md"><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-full"><div><figure class=""><noscript><img decoding="async" width="800" height="751" src="https://www.bioagilytix.com/wp-content/uploads/2023/08/t-cell_433526728.png" alt="" class="wp-image-3243" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/t-cell_433526728.png 800w, https://www.bioagilytix.com/wp-content/uploads/2023/08/t-cell_433526728-300x282.png 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/t-cell_433526728-768x721.png 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/t-cell_433526728-100x94.png 100w" sizes="(max-width: 800px) 100vw, 800px" /></noscript><img decoding="async" width="800" height="751" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%20800%20751%22%3E%3C/svg%3E' data-src="https://www.bioagilytix.com/wp-content/uploads/2023/08/t-cell_433526728.png" alt="" class="lazyload wp-image-3243" data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/t-cell_433526728.png 800w, https://www.bioagilytix.com/wp-content/uploads/2023/08/t-cell_433526728-300x282.png 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/t-cell_433526728-768x721.png 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/t-cell_433526728-100x94.png 100w" data-sizes="(max-width: 800px) 100vw, 800px" /></figure></div></div></div><div class="wp-block-emagine-column em-col-middle"><h2 class="has-em-white-color has-text-color h2">Global regulatory support for ATMPs</h2><p class="">In addition to having experience with a wide range of techniques and methodologies for designing appropriate assays for ATMP studies, BioAgilytix is able to supply the necessary level of regulatory oversight for each assay and each stage of your program.  Our global facilities can provide non-regulated or GLP, GCLP, GMP, and CLIA compliant assays.  We also maintain a robust assay transfer program in order to perform internal assay transfers in the event that a clinical program has global requirements for bioanalysis.  Together, these capabilities  ensure that BioAgilytix can provide bioanalytical support for ATMP programs from early phase pre-clinical all the way through approval and post-marketing. </p></div></div></div></div></div></div><div id="block_da3b56700a7b209dafeb0c97924b0bca" class="wp-block em-media-content em-mt--md em-mb--md 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/shutterstock_2256514059.jpg" alt="scientist women using laptop" class="object-fit--cover" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2256514059.jpg 1000w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2256514059-300x200.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2256514059-768x512.jpg 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2256514059-100x67.jpg 100w" width="1000" height="667"></noscript><img decoding="async" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%201000%20667%22%3E%3C/svg%3E' data-src="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2256514059.jpg" alt="scientist women using laptop" class="lazyload object-fit--cover" data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2256514059.jpg 1000w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2256514059-300x200.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2256514059-768x512.jpg 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2256514059-100x67.jpg 100w" width="1000" height="667"></div><div class="em-media-content__content em-media-content__content--left em-media-content__content--add-padding"><h2 class="h2">BioAgilytix as an industry leader for ATMPs</h2><p class="">As the available body of data continues to expand for these various types of ATMPs, the expectations for assays to support these drug programs evolves also.  Global regulatory agencies and international bodies continually modify their expectations in the form of revised procedural advice and guidelines.  At BioAgilytix, we work closely with regulatory and industry working groups to ensure that we are always at the forefront of the field, ready to implement new requirements in a seemless and compliant manner when they occur.  Our scientific experts actively partner with our clients to ensure successful, on-time delivery of data that is consistent with current regulatory expectations to aide in driving the success of your ATMP therapeutic programs. </p></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 d="M12.04 18.13v-.14c2.53-1.16 3.8-2.91 3.8-5.23 0-.87-.16-1.61-.49-2.24s-.78-1.11-1.36-1.45c-.64-.38-1.4-.65-2.28-.8-.66-.11-1.51-.17-2.56-.17H0v1.02c.35.1.63.22.83.35s.35.29.45.5.16.47.18.8.04.73.04 1.22v13.3c0 .5-.01.9-.04 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