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Vital global product development & regulatory consulting expertise. Analytical testing methods." /><link rel="canonical" href="https://www.bioagilytix.com/solutions/bioanalytical-laboratory-services/cmc-analytical-development/" /><meta property="og:locale" content="en_US" /><meta property="og:type" content="article" /><meta property="og:title" content="CMC Analytical Development Services | BioAgilytix" /><meta property="og:description" content="CMC analytical development services with BioAgilytix! Vital global product development & regulatory consulting expertise. Analytical testing methods." /><meta property="og:url" content="https://www.bioagilytix.com/solutions/bioanalytical-laboratory-services/cmc-analytical-development/" /><meta property="og:site_name" content="BioAgilytix" /><meta property="article:publisher" content="https://www.facebook.com/BioAgilytix/" /><meta property="article:modified_time" content="2024-11-13T09:13:07+00:00" /><meta property="og:image" content="https://www.bioagilytix.com/wp-content/uploads/2023/08/map-green.svg" /><meta name="twitter:card" content="summary_large_image" /><meta name="twitter:site" content="@bioagilytix" /><meta name="twitter:label1" content="Est. reading time" /><meta name="twitter:data1" content="5 minutes" /> <script defer 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-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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masthead__button btn--size-md" href="https://www.bioagilytix.com/speak-to-scientist/">Speak to a Scientist</a></div></div></div><div class="breadcrumbs"><span><span><a 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/bioanalytical-laboratory-services/">Services</a></span> <span class="breadcrumb-separator"></span> <span class="breadcrumb_last" aria-current="page">Chemistry, Manufacturing, & Controls (CMC)</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 em-mb--md">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><div id="block_46818a7b832ac33dcea366c97c8816aa" class="wp-block em-media-content em-mt--lg em-mb--xl 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/2023/08/iStock-1027139762-1-1380x776.jpg" alt="lab staff" class="object-fit--cover" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-1027139762-1-1380x776.jpg 1380w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-1027139762-1-2000x1125.jpg 2000w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-1027139762-1-1120x630.jpg 1120w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-1027139762-1-850x478.jpg 850w, https://www.bioagilytix.com/wp-content/uploads/2023/08/iStock-1027139762-1-640x360.jpg 640w" width="1380" height="776"></div><div class="em-media-content__content em-media-content__content--right em-media-content__content--add-padding"><div class="wp-block-emagine-spacer wp-block-emagine-spacer--md" aria-hidden="true"></div><h2 class="h2"><strong>Analytical testing services for biopharmaceutical product development</strong></h2><p class="">BioAgilytix has expertise with a wide array of CMC bioanalytical readouts and across many therapeutic modalities. Our team possesses deep expertise in the CMC field and can provide guidance for designing the appropriate manufacturing support package from purity and sterility testing to potency assays for lot release testing. Our bioanalytical development and testing experts can support your biopharmaceutical product through all phases of drug development. We are committed to finding the most efficient and appropriate path to advance your project.</p><div class="wp-block-emagine-spacer wp-block-emagine-spacer--md" aria-hidden="true"></div></div></div></div><h2 class="h2">CMC Bioanalytical services</h2><div id="block_2514e35024cac2059d95b15533e94d3e" class="wp-block em-tabs is-style-vertical em-mt--md alignwide"><div class="em-tabs__inner"><div class="em-tabs__tablist" role="tablist"></div><div class="em-tabs__tabpanels"><div id="em-tabpanel-67409e1e15850" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-67409e1e15850-control" > <button id="em-tabpanel-67409e1e15850-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-67409e1e15850" tabindex="-1" > <span class="em-tab-control__text">Assay Types</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">Assay Types</h3><div class="wp-block-emagine-grid wp-block-emagine-grid--halves"><div class="wp-block-emagine-grid__inner em-grid-2_sm-1-equalHeight-left"><div class="wp-block-emagine-column em-col"><h4 class="has-primary-color has-text-color h4">Potency / strength / content / identity</h4><ul class="wp-block-list is-style-default has-medium-font-size wp-block-list"><li class="">Expressed proteins</li><li class="">Expressed GOI</li><li class="">Biomarkers and related cellular indicators</li><li class="">Activated/deactivated target genes</li><li class="">Genome and Viral titer</li><li class="">Infection/transfection/transduction efficiency</li><li class="">Capsid/viral particle number</li></ul></div><div class="wp-block-emagine-column em-col"><h4 class="has-primary-color has-text-color h4">Impurity and trace analysis</h4><ul class="wp-block-list is-style-default has-medium-font-size wp-block-list"><li class="">Trace impurities</li><li class="">Host cell proteins</li><li class="">Residual host DNA</li><li class="">Residual insulin, antibiotic, and other process residuals</li><li class="">Residual plasmid</li></ul></div></div></div></div></div></div><div id="em-tabpanel-67409e1e15ac5" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-67409e1e15ac5-control" > <button id="em-tabpanel-67409e1e15ac5-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-67409e1e15ac5" tabindex="-1" > <span class="em-tab-control__text">Analytical Format</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">Analytical Format</h3><ul class="wp-block-list has-medium-font-size wp-block-list"><li class="">Cell-based assays</li><li class="">Immunoassays</li><li class="">Molecular assasys</li><li class="">Image analysis</li><li class="">Enzyme activity assays</li><li class="">Mass spectrometry</li></ul></div></div></div><div id="em-tabpanel-67409e1e15fbc" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-67409e1e15fbc-control" > <button id="em-tabpanel-67409e1e15fbc-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-67409e1e15fbc" tabindex="-1" > <span class="em-tab-control__text">Expertise</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">Expertise</h3><ul class="wp-block-list is-style-two-column has-medium-font-size wp-block-list"><li class="">Proliferation</li><li class="">Activity assays</li><li class="">Panel screens</li><li class="">ADCC/CDC</li><li class="">Neutralization assays</li><li class="">MOA determination</li><li class="">Trace analysis</li><li class="">Cell culture including master/working banks</li><li class="">Protein chemistry</li></ul></div></div></div></div></div></div><div id="block_375da78184999f95a73b2f94977513d5" class="wp-block em-media-content em-mt--lg em-mb--none 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"> <noscript><img decoding="async" src="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145.jpg" alt="well plate sample rack" class="object-fit--cover" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145.jpg 1000w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145-300x169.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145-768x432.jpg 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145-850x478.jpg 850w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145-640x360.jpg 640w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145-100x56.jpg 100w" width="1000" height="563"></noscript><img decoding="async" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%201000%20563%22%3E%3C/svg%3E' data-src="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145.jpg" alt="well plate sample rack" class="lazyload object-fit--cover" data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145.jpg 1000w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145-300x169.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145-768x432.jpg 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145-850x478.jpg 850w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145-640x360.jpg 640w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_2340383145-100x56.jpg 100w" width="1000" height="563"></div><div class="em-media-content__content em-media-content__content--right em-media-content__content--add-padding"><h3 class="h3">Advanced platforms for CMC support</h3><p class="">The array of assay types required for a full CMC support package require a bioanalytical provider with access to and experience with diverse platforms. At BioAgilytix, we utilize the latest CMC analytical and detection platforms including:</p><ul class="wp-block-list"><li class="">Multiplex ELISA (MSD-ECL)</li><li class="">Flow Cytometry</li><li class="">qPCR/ddPCR</li><li class="">LI-COR Odyssey/ChemiDoc</li><li class="">ELISA</li><li class="">LC/MS</li><li class="">HRMS</li><li class="">Capillary Electrophoresis (CE)</li></ul></div></div></div><div class="wp-block-emagine-background alignfull has-quaternary-background-color has-background-dim em-pt--xl em-pb--xl em-mt--none em-mb--none"><picture><source data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/map-green.svg" media="(max-width: 640px)"/><source data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/map-green.svg" media="(max-width: 1120px)"/><noscript><img decoding="async" class="wp-block-emagine-background__media wp-image-4066" alt="" src="https://www.bioagilytix.com/wp-content/uploads/2023/08/map-green.svg"/></noscript><img decoding="async" class="lazyload wp-block-emagine-background__media wp-image-4066" alt="" 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/2023/08/map-green.svg"/></picture><div class="wp-block-emagine-background__content"><div class="wp-block-emagine-background__content-inner"><h2 class="has-em-white-color has-text-color has-text-align-center h2">Global CMC Bioanalytical support</h2><p class="has-text-align-center has-medium-font-size">In addition to our full CMC-analytical team at the BioAgilytix headquarters in Durham, North Carolina, our European facility in Hamburg, Germany is GMP-compliant and provides quality control testing for product and batch release of biologicals. With this global presence, BioAgilytix has the flexibility to support our sponsors, no matter where their therapeutics are manufactured.</p><div id="block_aa64eb19ec0692a583749871af533ac8" class="wp-block em-icon-content em-mt--md alignwide"><div class="em-icon-content__container align--left"><div class="em-icon-content__content"><p class="has-primary-l-color has-text-color has-text-align-center h6 is-style-default">PRESS RELEASE</p><h2 class="has-em-white-color has-text-color has-text-align-center h2">Learn more about our European presence</h2><div class="wp-block-emagine-buttons has-text-align-center white-txt-btn"><div class="wp-block-emagine-button has-text-align-left"><a class="btn btn--size-md btn--style-primary has-primary-l-background-color" rel=""><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div></div></div></div></div><div id="block_0501f437ce0c29d97aa53bb45dec9f2c" class="wp-block em-media-content em-mt--none em-mb--lg alignfull"><div class="em-media-content__inner em-media-content__inner--media-left has-none-background-color em-media-content__inner--content-has-padding"><div class="em-media-content__media em-media-content__media--left"> <noscript><img decoding="async" src="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571-1380x776.jpg" alt="machine filling" class="object-fit--cover" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571-1380x776.jpg 1380w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571-2000x1125.jpg 2000w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571-1120x630.jpg 1120w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571-850x478.jpg 850w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571-640x360.jpg 640w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571.jpg 1000w" width="1380" height="776"></noscript><img decoding="async" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%201380%20776%22%3E%3C/svg%3E' data-src="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571-1380x776.jpg" alt="machine filling" class="lazyload object-fit--cover" data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571-1380x776.jpg 1380w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571-2000x1125.jpg 2000w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571-1120x630.jpg 1120w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571-850x478.jpg 850w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571-640x360.jpg 640w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1884612571.jpg 1000w" 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>BioAgilytix鈥檚 solutions for CMC Bioanalytical challenges </strong></h2><p class="">Due to the unique considerations for each drug modality and program, there are many challenging aspects of designing and implementing successful manufacturing programs, including the bioanalytical strategy. Common challenges in CMC development include:</p><ul class="wp-block-list"><li class="">The need to <strong>scale up</strong> from laboratory to commercial production.</li><li class="">Ensuring consistent and accurate <strong>method transfer</strong> between labs.</li><li class="">Navigating complex <strong>regulatory requirements</strong> and guidelines.</li><li class="">Addressing <strong>resource</strong> <strong>limitations</strong> such as access to specialized equipment and expertise.</li><li class="">Effectively managing <strong>communication</strong> and collaboration across different time zones. </li></ul><p class="">These challenges require careful planning, coordination, and expertise to ensure successful CMC development and regulatory approval.</p></div></div></div><p class="has-text-align-center has-large-font-size">With our global network of advanced laboratories and highly experienced scientists, BioAgilytix allows sponsors to effectively address these and other challenges facing successful CMC development.</p><div id="block_04dbfc22f9bc1ce37a0686e2d98abfad" class="wp-block em-icon-content-grid em-mt--md alignfull"><div class="em-icon-content-grid__container "><div class="alignwide"><div class="em-icon-content-grid__inner em-grid-2_md-2_xs-1"><div id="block_244cafdd1c18c675dad1e1fcfd2914f2" class="wp-block em-icon-content aligndefault"><div class="em-icon-content__container align--left"><div class="em-icon-content__content"><h4 class=""><strong>Scalability</strong>:</h4><p class="">Our global network of labs supports scaling up from laboratory-scale to commercial-scale production, offering expertise in process optimization and scale-up strategies.</p></div></div></div><div id="block_244cafdd1c18c675dad1e1fcfd2914f2" class="wp-block em-icon-content aligndefault"><div class="em-icon-content__container align--left"><div class="em-icon-content__content"><h4 class=""><strong>Method transfer</strong>:</h4><p class="">Our network enables seamless transfer, validation, and implementation of analytical methods across different sites, ensuring consistency and accuracy.</p></div></div></div><div id="block_244cafdd1c18c675dad1e1fcfd2914f2" class="wp-block em-icon-content aligndefault"><div class="em-icon-content__container align--left"><div class="em-icon-content__content"><h3 class="h3"><strong>Resource availability</strong>:</h3><p class="">BioAgilytix provides sponsors access to a wide range of innovative technologies, instrumentation, and expertise, ensuring availability of specialized resources.</p></div></div></div><div id="block_244cafdd1c18c675dad1e1fcfd2914f2" class="wp-block em-icon-content aligndefault"><div class="em-icon-content__container align--left"><div class="em-icon-content__content"><h4 class=""><strong>Regulatory compliance:</strong></h4><p class="">BioAgilytix stays up to date with regulatory standards across regions and countries, leveraging our global network to ensure compliance throughout the process, worldwide.</p></div></div></div><div id="block_244cafdd1c18c675dad1e1fcfd2914f2" class="wp-block em-icon-content aligndefault"><div class="em-icon-content__container align--left"><div class="em-icon-content__content"><h4 class=""><strong>Communication</strong>:</h4><p class="">BioAgilytix efficiently manages communication and collaboration across different time zones, leveraging our global network to provide support and maintain effective communication with sponsors.</p></div></div></div></div></div></div></div><div class="wp-block-group alignwide is-layout-constrained wp-block-group-is-layout-constrained"></div><div id="block_bb26cbf278137a5eb84154441ac90394" class="wp-block em-call-to-action hide-cta 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=""></p><h2 class="has-text-align-center h2">Dose Formulation Analysis</h2><p class="has-medium-font-size">Dose confirmation analysis for formulation samples is an important part of any successful GLP study and is required by the United States Food and Drug Administration (USFDA) for formulations dosed in toxicology studies. We provide high quality, preclinical dose formulation analysis for both GLP and non-GLP studies, to ensure your study starts off on the right track.</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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