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font-weight: 300 !important; font-family: "Roboto Slab", helvetica, arial, sans-serif; top: 55px; left: 0px; background: #eab3a0; margin: 10px 0; padding: 10px 15px; } .hs-richtext { margin-bottom: 3px; font-family: "Roboto Slab", helvetica, arial, sans-serif; /* color: #FFFFFF;*/ font-weight: 400; font-size: 16px; line-height: 26px; } /* Hide the original checkbox */ ul.inputs-list.multi-container li.hs-form-checkbox label input, .hs-form-booleancheckbox-display input { height: 24px; left: 0; opacity: 0; position: absolute; top: 0; width: 24px; } /* Add new checkbox */ ul.inputs-list.multi-container li.hs-form-checkbox label span::before, .hs-form-booleancheckbox-display span::before { content: ""; border-radius: 0px; background-color: #ffffff; position: absolute; top: 4px; left: 8px; z-index: 1; display: block; width: 5px; height: 10px; border: solid #157479; border-width: 0 2px 2px 0; -webkit-transform: rotate(45deg); -ms-transform: rotate(45deg); transform: rotate(45deg); opacity: 0; -webkit-transition-duration: .1s; -o-transition-duration: .1s; transition-duration: .1s; -webkit-transition-property: border-color; -o-transition-property: border-color; transition-property: 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{ padding-right: 10px; } .hbspt-form .hs-lastname, .kits_form_col .hs_confirm_email{ padding-left: 10px; } .kits_form_col {padding-bottom: 108px;} .hs-richtext h4 {margin-bottom: 30px !important;} .kits_form_col label.hs-form-checkbox-display {margin-bottom: 20px;} } @media screen and (max-width: 640px){ .hbspt-form h1{font-size: 32px !important;} .hbspt-form .gform_heading p{font-size: 16px !important;} .hbspt-form .form-columns-2 .field{ -webkit-box-flex: 0; -ms-flex: 0 0 100%; flex: 0 0 100%; margin-bottom: .5rem; padding-left: 0; } } @media screen and (max-width: 540px){ .event-hero-section > div{ justify-items: flex-start !important; } } @media screen and (max-width: 414px){ body .hubspot_signup_form .hs_email {width: 66% !important;} body .hubspot_signup_form ul.no-list{top: 65px !important;} } @media screen and (max-width: 320px){ body .hubspot_signup_form .hs_email {width: 61% !important;} }</style> <style type="text/css">.about-presenter-section{display:none;} .space-hero-section{margin-bottom:0px !important;} .partner_bioAgilytix {padding-right: 2.5rem !important;} @media screen and (max-width: 540px){ .event-hero-section > div{ justify-items: flex-start !important; } }</style> <style type="text/css">/* Add your CSS code here. 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href="https://www.bioagilytix.com/scientific-expertise/">Scientific Expertise</a></span> <span class="breadcrumb-separator"></span> <span><a href="https://www.bioagilytix.com/scientific-expertise/scientific-insights/">Scientific Insights</a></span> <span class="breadcrumb-separator"></span> <span><a href="https://www.bioagilytix.com/scientific-expertise/scientific-insights/posters/">Scientific Posters</a></span> <span class="breadcrumb-separator"></span> <span class="breadcrumb_last" aria-current="page">Potency Assay Development for Gene Therapy Products – Approaches and Points to Consider in Data Processing</span></span></div></div></section><div class="em-news alignwide"><div class="em-news__content aligndefault"><p class="">Purpose</p><p class="">Gene therapies – including AAVs, engineered viruses and polymer formulated oligonucleotides/plasmids – are among the highest growth area in biopharmaceuticals. They provide great promise as therapeutics but present many development challenges owing to their complex mechanisms of action (MOA). Potency assays play a pivotal role in the development of nearly every biologic and are an expectation of global regulatory agencies. These assays take many forms depending on the MOA of the biologic and include analysis of cell activity using ELISAs, Flow Cytometry, and ddPCR/qPCR. The cells and the readout are critical but so is the appropriate processing of the data to derive a relative potency. Here case studies for representative gene therapies have been provided as examples of the challenges encountered in acquiring and processing data. Different data modelling is applied to achieve robust outcomes that meet the requirements of a GMP Relative Potency assay. We include discussion of phase appropriateness and the risks and benefits of differing approaches. The modalities include a plasmid gene therapeutic as well as AAVs. Dilution series, ranges and other aspects of the assay execution are optimized to better fit the best processing paradigm</p><div class="wp-block-emagine-button gated-content__download-button em-mt--md em-mb--md" data-resource-type="file"> <a class="btn btn--size-md btn--style-primary has-primary-background-color" href="https://www.bioagilytix.com/wp-content/uploads/2024/06/W0930-09-56_AAPS_Poster_JSP.pdf" target="_blank" rel="noopener norefferer"> <span>Download Poster</span> </a></div><div class="pagination"><div class="nav-previous alignleft"><a href="https://www.bioagilytix.com/scientific-expertise/scientific-insights/toxicokinetics-of-pirfenidone-in-dogs-following-inhalation-in-a-nebulized-aerosol-formulation-2/" rel="prev">Toxicokinetics of Pirfenidone in Dogs Following Inhalation in a Nebulized Aerosol Formulation</a></div><div class="nav-next alignright"><a href="https://www.bioagilytix.com/scientific-expertise/scientific-insights/qualification-of-a-neurology-2-plex-b-nf-l-gfap-quanterix-simoa-assay-using-a-novel-approach/" rel="next">Qualification of a Neurology 2-Plex B (Nf-L, GFAP) Quanterix Simoa® Assay Using a Novel Approach</a></div></div></div><div class="em-news--image-container"><div class="em-news__media"><div class="em-news__media-inner"> <img src="https://www.bioagilytix.com/wp-content/uploads/2024/06/potency-assay-dev_thumb.jpg" alt="" class="object-fit--cover" srcset="https://www.bioagilytix.com/wp-content/uploads/2024/06/potency-assay-dev_thumb.jpg 800w, https://www.bioagilytix.com/wp-content/uploads/2024/06/potency-assay-dev_thumb-300x300.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2024/06/potency-assay-dev_thumb-150x150.jpg 150w, https://www.bioagilytix.com/wp-content/uploads/2024/06/potency-assay-dev_thumb-768x768.jpg 768w, 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