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padding-right:20px; } .ubermenu-responsive .ubermenu-item.ubermenu-hide-mobile{ /* Hiding items */ display:none !important; } .ubermenu-responsive.ubermenu-hide-bkgs .ubermenu-submenu.ubermenu-submenu-bkg-img{ /** Hide Background Images in Submenu */ background-image:none; } .ubermenu.ubermenu-responsive .ubermenu-item-level-0.ubermenu-item-mini{ min-width:0; width:auto; } .ubermenu-vertical .ubermenu-item.ubermenu-item-level-0{ width:100%; } .ubermenu-vertical.ubermenu-sub-indicators .ubermenu-item-level-0.ubermenu-item-has-children > .ubermenu-target > .ubermenu-sub-indicator{ right:10px; left:auto; transform:rotate(0); } .ubermenu-vertical .ubermenu-item.ubermenu-item-level-0.ubermenu-relative.ubermenu-active > .ubermenu-submenu-drop.ubermenu-submenu-align-vertical_parent_item{ top:auto; } .ubermenu.ubermenu-responsive .ubermenu-tabs{ position:static; } /* Tabs on Mobile with mouse (but not click) - leave space to hover off */ .ubermenu:not(.ubermenu-is-mobile):not(.ubermenu-submenu-indicator-closes) .ubermenu-submenu .ubermenu-tab[data-ubermenu-trigger="mouseover"] .ubermenu-tab-content-panel, .ubermenu:not(.ubermenu-is-mobile):not(.ubermenu-submenu-indicator-closes) .ubermenu-submenu .ubermenu-tab[data-ubermenu-trigger="hover_intent"] .ubermenu-tab-content-panel{ margin-left:6%; width:94%; min-width:94%; } /* Sub indicator close visibility */ .ubermenu.ubermenu-submenu-indicator-closes .ubermenu-active > .ubermenu-target > .ubermenu-sub-indicator-close{ display:block; display: flex; align-items: center; justify-content: center; } .ubermenu.ubermenu-submenu-indicator-closes .ubermenu-active > .ubermenu-target > .ubermenu-sub-indicator{ display:none; } .ubermenu .ubermenu-tabs .ubermenu-tab-content-panel{ box-shadow: 0 5px 10px rgba(0,0,0,.075); } /* When submenus and items go full width, move items back to appropriate positioning */ .ubermenu .ubermenu-submenu-rtl { direction: ltr; } /* Fixed position mobile menu */ .ubermenu.ubermenu-mobile-modal{ position:fixed; z-index:9999999; opacity:1; top:0; left:0; width:100%; width:100vw; max-width:100%; max-width:100vw; height:100%; height:calc(100vh - calc(100vh - 100%)); height:-webkit-fill-available; max-height:calc(100vh - calc(100vh - 100%)); max-height:-webkit-fill-available; border:none; box-sizing:border-box; display:flex; flex-direction:column; justify-content:flex-start; overflow-y:auto !important; /* for non-accordion mode */ overflow-x:hidden !important; overscroll-behavior: contain; transform:scale(1); transition-duration:.1s; transition-property: all; } .ubermenu.ubermenu-mobile-modal.ubermenu-mobile-accordion.ubermenu-interaction-press{ overflow-y:hidden !important; } .ubermenu.ubermenu-mobile-modal.ubermenu-responsive-collapse{ overflow:hidden !important; opacity:0; transform:scale(.9); visibility:hidden; } .ubermenu.ubermenu-mobile-modal .ubermenu-nav{ flex:1; overflow-y:auto !important; overscroll-behavior: contain; } .ubermenu.ubermenu-mobile-modal .ubermenu-item-level-0{ margin:0; } .ubermenu.ubermenu-mobile-modal .ubermenu-mobile-close-button{ border:none; background:none; border-radius:0; padding:1em; color:inherit; display:inline-block; text-align:center; font-size:14px; } .ubermenu.ubermenu-mobile-modal .ubermenu-mobile-footer .ubermenu-mobile-close-button{ width: 100%; display: flex; align-items: center; justify-content: center; } .ubermenu.ubermenu-mobile-modal .ubermenu-mobile-footer .ubermenu-mobile-close-button .ubermenu-icon-essential, .ubermenu.ubermenu-mobile-modal .ubermenu-mobile-footer .ubermenu-mobile-close-button .fas.fa-times{ margin-right:.2em; } /* Header/Footer Mobile content */ .ubermenu .ubermenu-mobile-header, .ubermenu .ubermenu-mobile-footer{ display:block; text-align:center; color:inherit; } /* Accordion submenus mobile (single column tablet) */ .ubermenu.ubermenu-responsive-single-column.ubermenu-mobile-accordion.ubermenu-interaction-press .ubermenu-item > .ubermenu-submenu-drop, .ubermenu.ubermenu-responsive-single-column.ubermenu-mobile-accordion.ubermenu-interaction-press .ubermenu-tab > .ubermenu-tab-content-panel{ box-sizing:border-box; border-left:none; border-right:none; box-shadow:none; } .ubermenu.ubermenu-responsive-single-column.ubermenu-mobile-accordion.ubermenu-interaction-press .ubermenu-item.ubermenu-active > .ubermenu-submenu-drop, .ubermenu.ubermenu-responsive-single-column.ubermenu-mobile-accordion.ubermenu-interaction-press .ubermenu-tab.ubermenu-active > .ubermenu-tab-content-panel{ position:static; } /* Accordion indented - remove borders and extra spacing from headers */ .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu.ubermenu-submenu-drop, .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu .ubermenu-item-header.ubermenu-has-submenu-stack > .ubermenu-target{ border:none; } .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu .ubermenu-item-header.ubermenu-has-submenu-stack > .ubermenu-submenu-type-stack{ padding-top:0; } /* Accordion dropdown indentation padding */ .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu-drop .ubermenu-submenu-drop .ubermenu-item > .ubermenu-target, .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu-drop .ubermenu-tab-content-panel .ubermenu-item > .ubermenu-target{ padding-left:calc( var(--ubermenu-accordion-indent) * 2 ); } .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu-drop .ubermenu-submenu-drop .ubermenu-submenu-drop .ubermenu-item > .ubermenu-target, .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu-drop .ubermenu-tab-content-panel .ubermenu-tab-content-panel .ubermenu-item > .ubermenu-target{ padding-left:calc( var(--ubermenu-accordion-indent) * 3 ); } .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu-drop .ubermenu-submenu-drop .ubermenu-submenu-drop .ubermenu-submenu-drop .ubermenu-item > .ubermenu-target, .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu-drop .ubermenu-tab-content-panel .ubermenu-tab-content-panel .ubermenu-tab-content-panel .ubermenu-item > .ubermenu-target{ padding-left:calc( var(--ubermenu-accordion-indent) * 4 ); } /* Reverse Accordion dropdown indentation padding */ .rtl .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu-drop .ubermenu-submenu-drop .ubermenu-item > .ubermenu-target, .rtl .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu-drop .ubermenu-tab-content-panel .ubermenu-item > .ubermenu-target{ padding-left:0; padding-right:calc( var(--ubermenu-accordion-indent) * 2 ); } .rtl .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu-drop .ubermenu-submenu-drop .ubermenu-submenu-drop .ubermenu-item > .ubermenu-target, .rtl .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu-drop .ubermenu-tab-content-panel .ubermenu-tab-content-panel .ubermenu-item > .ubermenu-target{ padding-left:0; padding-right:calc( var(--ubermenu-accordion-indent) * 3 ); } .rtl .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu-drop .ubermenu-submenu-drop .ubermenu-submenu-drop .ubermenu-submenu-drop .ubermenu-item > .ubermenu-target, .rtl .ubermenu.ubermenu-mobile-accordion-indent .ubermenu-submenu-drop .ubermenu-tab-content-panel .ubermenu-tab-content-panel .ubermenu-tab-content-panel .ubermenu-item > .ubermenu-target{ padding-left:0; padding-right:calc( var(--ubermenu-accordion-indent) * 4 ); } .ubermenu-responsive-toggle{ display:block; } } @media screen and (max-width: 480px){ .ubermenu.ubermenu-responsive .ubermenu-item-level-0{ width:100%; } .ubermenu.ubermenu-responsive .ubermenu-column, .ubermenu.ubermenu-responsive .ubermenu-column-auto{ min-width:100%; } .ubermenu .ubermenu-autocolumn:not(:first-child), .ubermenu .ubermenu-autocolumn:not(:first-child) .ubermenu-submenu-type-stack{ padding-top:0; } .ubermenu .ubermenu-autocolumn:not(:last-child), .ubermenu .ubermenu-autocolumn:not(:last-child) .ubermenu-submenu-type-stack{ padding-bottom:0; } .ubermenu .ubermenu-autocolumn > .ubermenu-submenu-type-stack > .ubermenu-item-normal:first-child{ margin-top:0; } /* Accordion submenus mobile */ .ubermenu.ubermenu-responsive.ubermenu-mobile-accordion.ubermenu-interaction-press .ubermenu-item > .ubermenu-submenu-drop, .ubermenu.ubermenu-responsive.ubermenu-mobile-accordion.ubermenu-interaction-press .ubermenu-tab > .ubermenu-tab-content-panel{ box-shadow:none; box-sizing:border-box; border-left:none; border-right:none; } .ubermenu.ubermenu-responsive.ubermenu-mobile-accordion.ubermenu-interaction-press .ubermenu-item.ubermenu-active > .ubermenu-submenu-drop, .ubermenu.ubermenu-responsive.ubermenu-mobile-accordion.ubermenu-interaction-press .ubermenu-tab.ubermenu-active > .ubermenu-tab-content-panel{ position:static; } } /** UberMenu Custom Menu Styles (Customizer) **/ /* main */ .ubermenu.ubermenu-main { background:none; border:none; box-shadow:none; } .ubermenu.ubermenu-main .ubermenu-item-level-0 > .ubermenu-target { border:none; box-shadow:none; } .ubermenu.ubermenu-main.ubermenu-horizontal .ubermenu-submenu-drop.ubermenu-submenu-align-left_edge_bar, .ubermenu.ubermenu-main.ubermenu-horizontal .ubermenu-submenu-drop.ubermenu-submenu-align-full_width { left:0; } .ubermenu.ubermenu-main.ubermenu-horizontal .ubermenu-item-level-0.ubermenu-active > .ubermenu-submenu-drop, .ubermenu.ubermenu-main.ubermenu-horizontal:not(.ubermenu-transition-shift) .ubermenu-item-level-0 > .ubermenu-submenu-drop { margin-top:0; } .ubermenu-main .ubermenu-item-level-0 > .ubermenu-target { font-size:14px; text-transform:uppercase; color:#333333; } .ubermenu-main .ubermenu-nav .ubermenu-item.ubermenu-item-level-0 > .ubermenu-target { font-weight:700; } .ubermenu.ubermenu-main .ubermenu-item-level-0:hover > .ubermenu-target, .ubermenu-main .ubermenu-item-level-0.ubermenu-active > .ubermenu-target { color:#67686b; } .ubermenu-main .ubermenu-item-level-0.ubermenu-current-menu-item > .ubermenu-target, .ubermenu-main .ubermenu-item-level-0.ubermenu-current-menu-parent > .ubermenu-target, .ubermenu-main .ubermenu-item-level-0.ubermenu-current-menu-ancestor > .ubermenu-target { color:#67686b; } .ubermenu.ubermenu-main .ubermenu-item-level-0 { margin:15px 10px; } .ubermenu-main .ubermenu-submenu .ubermenu-item-header > .ubermenu-target, .ubermenu-main .ubermenu-tab > .ubermenu-target { font-size:14px; } .ubermenu-main .ubermenu-submenu .ubermenu-item-header > .ubermenu-target { color:#67686b; } .ubermenu-main .ubermenu-submenu .ubermenu-item-header > .ubermenu-target:hover { color:#67686b; } .ubermenu-main .ubermenu-submenu .ubermenu-item-header.ubermenu-current-menu-item > .ubermenu-target { color:#67686b; } .ubermenu-main .ubermenu-nav .ubermenu-submenu .ubermenu-item-header > .ubermenu-target { font-weight:normal; } .ubermenu-main .ubermenu-submenu .ubermenu-item-header.ubermenu-has-submenu-stack > .ubermenu-target { border:none; } .ubermenu-main .ubermenu-submenu-type-stack { padding-top:0; } .ubermenu-responsive-toggle.ubermenu-responsive-toggle-main { font-size:16px; } .ubermenu-main, .ubermenu-main .ubermenu-target, .ubermenu-main .ubermenu-nav .ubermenu-item-level-0 .ubermenu-target, .ubermenu-main div, .ubermenu-main p, .ubermenu-main input { font-family:'Open Sans', sans-serif; font-weight:400; } /* footer-menu */ .ubermenu.ubermenu-footer-menu { background:none; border:none; box-shadow:none; } .ubermenu.ubermenu-footer-menu .ubermenu-item-level-0 > .ubermenu-target { border:none; box-shadow:none; } .ubermenu.ubermenu-footer-menu.ubermenu-horizontal .ubermenu-submenu-drop.ubermenu-submenu-align-left_edge_bar, .ubermenu.ubermenu-footer-menu.ubermenu-horizontal .ubermenu-submenu-drop.ubermenu-submenu-align-full_width { left:0; } .ubermenu.ubermenu-footer-menu.ubermenu-horizontal .ubermenu-item-level-0.ubermenu-active > .ubermenu-submenu-drop, .ubermenu.ubermenu-footer-menu.ubermenu-horizontal:not(.ubermenu-transition-shift) .ubermenu-item-level-0 > .ubermenu-submenu-drop { margin-top:0; } .ubermenu-footer-menu .ubermenu-item-level-0 > .ubermenu-target { text-transform:uppercase; border:none; } .ubermenu-footer-menu .ubermenu-submenu .ubermenu-item-header > .ubermenu-target, .ubermenu-footer-menu .ubermenu-tab > .ubermenu-target { text-transform:uppercase; } .ubermenu-footer-menu .ubermenu-submenu .ubermenu-item-header.ubermenu-has-submenu-stack > .ubermenu-target { border:none; } .ubermenu-footer-menu .ubermenu-submenu-type-stack { padding-top:0; } .ubermenu-footer-menu .ubermenu-item-normal > .ubermenu-target { font-size:14px; } .ubermenu-footer-menu, .ubermenu-footer-menu .ubermenu-target, .ubermenu-footer-menu .ubermenu-nav .ubermenu-item-level-0 .ubermenu-target, .ubermenu-footer-menu div, .ubermenu-footer-menu p, .ubermenu-footer-menu input { font-family:'Open Sans', sans-serif; } /* top_menu */ .ubermenu-top_menu .ubermenu-item-level-0 > .ubermenu-target { color:#ffffff; } .ubermenu.ubermenu-top_menu .ubermenu-item-level-0:hover > .ubermenu-target, .ubermenu-top_menu .ubermenu-item-level-0.ubermenu-active > .ubermenu-target { color:#37c2dc; } .ubermenu-top_menu .ubermenu-item-level-0.ubermenu-current-menu-item > .ubermenu-target, .ubermenu-top_menu .ubermenu-item-level-0.ubermenu-current-menu-parent > .ubermenu-target, .ubermenu-top_menu .ubermenu-item-level-0.ubermenu-current-menu-ancestor > .ubermenu-target { color:#37c2dc; } .ubermenu-top_menu .ubermenu-item.ubermenu-item-level-0 > .ubermenu-highlight { color:#37c2dc; } .ubermenu-top_menu .ubermenu-item-normal > .ubermenu-target { color:#ffffff; font-size:17px; font-weight:bold; } .ubermenu.ubermenu-top_menu .ubermenu-item-normal > .ubermenu-target:hover, .ubermenu.ubermenu-top_menu .ubermenu-item-normal.ubermenu-active > .ubermenu-target { color:#37c2dc; } .ubermenu-top_menu .ubermenu-item-normal.ubermenu-current-menu-item > .ubermenu-target { color:#37c2dc; } /** UberMenu Custom Menu Item Styles (Menu Item Settings) **/ /* 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e17391-e3 mdf3-j mdf3-k mdf3-l"><a href="https://biocentriqstg.wpengine.com/" class="x-text x-text-headline e17391-e4 mdf3-n mdf3-o mdf3-p breadcrumbs"><div class="x-text-content"><div class="x-text-content-text"><h3 class="x-text-content-text-primary"><a class="bc-home bc-link" href="/"><img decoding="async" style="margin: 0px 5px 5px 0px;" src="/wp-content/uploads/2022/10/home.svg"> HOME</a> <img decoding="async" style="margin: 5px 5px 1px 5px;" src="/wp-content/uploads/2022/10/chevron-right.svg"> <a class="bc-category bc-link" href="#">FAQs</a></h3></div></div></a><div id="title-heading" class="x-text x-text-headline e17391-e5 mdf3-o mdf3-q mdf3-r"><div class="x-text-content"><div class="x-text-content-text"><h1 class="x-text-content-text-primary">Frequently Asked Questions</h1></div></div></div></div></div></div></div><div class="x-section e17391-e6 mdf3-0 mdf3-2 mdf3-3 mdf3-4"><div class="x-row x-container max width e17391-e7 mdf3-8 mdf3-a mdf3-c mdf3-d"><div class="x-row-inner"><div class="x-col e17391-e8 mdf3-j mdf3-k"><div class="x-text x-text-headline e17391-e9 mdf3-o mdf3-p mdf3-r mdf3-s"><div class="x-text-content"><div class="x-text-content-text"><h2 class="x-text-content-text-primary">BioCentriq's Approach</h2></div></div></div></div><div class="x-col e17391-e10 mdf3-j mdf3-m"><div class="x-acc e17391-e11 mdf3-t accordion" id="x-acc-e17391-e11"><div class="e17391-e12 x-acc-item"><button id="tab-e17391-e12" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e12" data-x-toggle="collapse" data-x-toggleable="e17391-e12"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">How long does it typically take to engage BioCentriq? </span></span><span class="EOP SCXW154714397 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></span></strong></span></span></button><div id="panel-e17391-e12" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e12" data-x-toggleable="e17391-e12" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;"><span class="TextRun SCXW165498733 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW165498733 BCX0">Of course, every project is different;</span><span class="NormalTextRun SCXW165498733 BCX0"> however, in general, </span><span class="NormalTextRun SpellingErrorV2Themed SCXW165498733 BCX0">BioCentriq</span><span class="NormalTextRun SCXW165498733 BCX0"> will move at your speed. We can typically </span><span class="NormalTextRun SCXW165498733 BCX0">engage </span><span class="NormalTextRun SCXW165498733 BCX0">as </span><span class="NormalTextRun SCXW165498733 BCX0">quickly</span><span class="NormalTextRun SCXW165498733 BCX0"> as you can. </span><span class="NormalTextRun SCXW165498733 BCX0">Our first step is to make sure there is a good fit between what you need and our capabilities and </span><span class="NormalTextRun SCXW165498733 BCX0">availability</span><span class="NormalTextRun SCXW165498733 BCX0">.  From there, we can quickly put an NDA in place so we can discuss your technology, </span><span class="NormalTextRun SCXW165498733 BCX0">requirements,</span><span class="NormalTextRun SCXW165498733 BCX0"> and timelines in detail</span><span class="NormalTextRun SCXW165498733 BCX0"> with our subject matter experts. </span><span class="NormalTextRun SCXW165498733 BCX0">After </span><span class="NormalTextRun SCXW165498733 BCX0">that, we will craft a proposal and work collaboratively to </span><span class="NormalTextRun SCXW165498733 BCX0">refine </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW165498733 BCX0">it</span><span class="NormalTextRun SCXW165498733 BCX0"> to the point where we have an agreed upon statement of work </span><span class="NormalTextRun SCXW165498733 BCX0">that we can convert to a contract</span><span class="NormalTextRun SCXW165498733 BCX0">. Once executed, we will assemble the team and start with a project kick-off meeting that gets all parties aligned and educated </span><span class="NormalTextRun SCXW165498733 BCX0">so from that point forward we are working in </span><span class="NormalTextRun SCXW165498733 BCX0">lockstep</span><span class="NormalTextRun SCXW165498733 BCX0"> to reach </span><span class="NormalTextRun SCXW165498733 BCX0">shared goals.</span></span><span class="EOP SCXW165498733 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></span></p> <p><span style="color: #67686b;"></div></div></div><div class="e17391-e13 x-acc-item"><button id="tab-e17391-e13" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e13" data-x-toggle="collapse" data-x-toggleable="e17391-e13"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What is your approach to project management?</span></strong></span></span></button><div id="panel-e17391-e13" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e13" data-x-toggleable="e17391-e13" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">We assign a dedicated project manager to your program who has relevant experience and background and can quickly get up to speed on the critical success factors for your project. You will assign a counterpart from your team who will be the primary point of contact for your organization. These two individuals will be in constant contact throughout the life of the project to make sure that both parties have everything they need to be successful including a clear understanding of timelines, dependencies, requirements, action items and project risks. </span></p> <p><strong><span style="color: #67686b;">Typical project management activities and deliverables </span></strong></p> <ul> <li><span style="color: #67686b;">Weekly project meetings with all core team members from both organizations </span></li> <li><span style="color: #67686b;">Weekly (or during certain times even daily!) project manager check-ins </span></li> <li><span style="color: #67686b;">A continuously updated and detailed project plan</span></li> <li><span style="color: #67686b;">Action and documentation trackers</span></li> <li><span style="color: #67686b;">Bills of material for all project phases (process development, pilot runs, engineering runs, clinical manufacturing, QC, Analytical method development, etc.) </span></li> <li><span style="color: #67686b;">Ad-hoc meetings as required to address key issues in process development, analytical method development, outsourced testing, manufacturing, supply chain, documentation and more. <br /> </span></li> </ul></div></div></div><div class="e17391-e14 x-acc-item"><button id="tab-e17391-e14" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e14" data-x-toggle="collapse" data-x-toggleable="e17391-e14"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What does your project team structure look like?</span></strong></span></span></button><div id="panel-e17391-e14" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e14" data-x-toggleable="e17391-e14" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b; font-family: inherit; font-size: 1em;"><span class="TextRun SCXW234569358 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW234569358 BCX0">The structure of every project team is depend</span><span class="NormalTextRun SCXW234569358 BCX0">ent on the scope and objectives of each project</span><span class="NormalTextRun SCXW234569358 BCX0">;</span><span class="NormalTextRun SCXW234569358 BCX0"> however, in general, each project is assigned </span><span class="NormalTextRun SCXW234569358 BCX0">a “core” team consisting of </span><span class="NormalTextRun SCXW234569358 BCX0">the following:</span></span><span class="EOP SCXW234569358 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span> </span></p> <ul> <li><span style="color: #67686b;">Primary project manager</span></li> <li><span style="color: #67686b;">Project management associate (if needed)</span></li> <li><span style="color: #67686b;"><span class="TextRun SCXW153280975 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW153280975 BCX0">Technical lead</span><span class="NormalTextRun SCXW153280975 BCX0"> (someone expert in your cell line</span><span class="NormalTextRun SCXW153280975 BCX0">, platform, </span><span class="NormalTextRun SCXW153280975 BCX0">process,</span><span class="NormalTextRun SCXW153280975 BCX0"> or vector)</span></span><span class="EOP SCXW153280975 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></span></li> <li><span style="color: #67686b;"><span class="TextRun SCXW36594885 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW36594885 BCX0">A primary point of contact or lead from the following areas:</span></span><span class="EOP SCXW36594885 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> p<span class="TextRun SCXW238668784 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW238668784 BCX0">rocess development </span><span class="NormalTextRun SCXW238668784 BCX0">and/or MSAT, quality control, quality assurance, manufacturing, and supply chain.</span></span></span><br /> </span></li> </ul> <p><span style="color: #67686b;"><span class="EOP SCXW36594885 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"><span class="TextRun SCXW238668784 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW238668784 BCX0"><span class="TextRun SCXW41546962 BCX0" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW41546962 BCX0">This “core” team will leverage and draw from their colleagues as required to support the success of your project.</span></span><span class="EOP SCXW41546962 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></span></span></span></span></p></div></div></div><div class="e17391-e15 x-acc-item"><button id="tab-e17391-e15" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e15" data-x-toggle="collapse" data-x-toggleable="e17391-e15"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">How do you price projects?</span></strong></span></span></button><div id="panel-e17391-e15" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e15" data-x-toggleable="e17391-e15" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">BioCentriq is uniquely equipped to price our projects according to client requirements. We price our manufacturing projects based on utilization of the clean rooms and the labor and time required to manufacture your product. We can offer you a consistent monthly price that is inclusive of both clean room utilization and lot or batch production based on your anticipated manufacturing schedule, or we can offer you a model that distinguishes between monthly clean room utilization and batch price, allowing you a bit more flexibility to scale up or down your manufacturing as well as the opportunity to maintain your clean room booking at a lower cost during lulls in production. Our process development and workforce programs are typically priced using a fee for service model. </div></div></div><div class="e17391-e16 x-acc-item"><button id="tab-e17391-e16" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e16" data-x-toggle="collapse" data-x-toggleable="e17391-e16"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What is a typical timeline for tech transfer?</span></strong></span></span></button><div id="panel-e17391-e16" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e16" data-x-toggleable="e17391-e16" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">We find the average tech transfer can take as long as 12 to 18 months to complete. However, BioCentriq utilizes a rapid or accelerated tech transfer process that consistently allows us to complete tech transfer in as short as six months.</span></p> <p><span style="color: #67686b;">The length of the tech transfer process depends entirely on the current state of your process and documentation and whether or not you are willing to leverage some of the "off-the-shelf" assets BioCentriq has developed that can be retrofitted for your product. </span></p> <p><span style="color: #808080;">You may also opt to take advantage of the LEAP Advanced Therapy platform which leverages our Rapid Tech Transfer process and includes additional benefits in terms of pre-existing documentation, at times, modality specific assets, such as proven feeder lines for NK cell therapies, and pre-qualified personnel, equipment, analytical methods and facilities.</span><span style="color: #67686b;"></span></p></div></div></div><div class="e17391-e17 x-acc-item"><button id="tab-e17391-e17" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e17" data-x-toggle="collapse" data-x-toggleable="e17391-e17"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What is your overall approach to tech transfer?</span></strong></span></span></button><div id="panel-e17391-e17" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e17" data-x-toggleable="e17391-e17" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">We start the process with knowledge sharing. Your team will share all available documentation, including current protocols and batch records, training documents, results of initial studies, and testing, BOM (bill of material) required for your product, drug product and drug substance specifications, CPP (control process parameters), QBD (quality by design) artifacts, and CMC documentation from any existing IND or other applications.</span></p> <p><strong>Feasibility Study</strong></p> <p><span style="color: #67686b;">Once the BioCentriq team has reviewed that documentation, the teams will discuss whether anything is needed prior to proceeding to the next step, which would be a feasibility study conducted in our pilot plant.</span></p> <p>Process Development - Optional</p> <p><span style="color: #67686b;">Sometimes the teams agree or anticipate from the beginning that additional process development would be required. At other times, process development work is not expected, and the goal is to move to clinical manufacturing as quickly as possible.</span></p> <p>Pilot Runs</p> <p><span style="color: #67686b;">After the BioCentriq team has completed the feasibility study and both teams acknowledge success, we will move to pilot runs, which are conducted in our pilot plant at a scale that imitates or approaches the scale and process planned for clinical manufacturing in a GMP environment. </span><span style="color: #67686b;">Most of our project plans call for anywhere from one to three pilot runs. </span></p> <p>Engineering Runs and GMP Readiness Activities</p> <p><span style="color: #67686b;">Lastly, we learn from pilot runs and prepare for engineering runs in the GMP environment. That readiness activity typically includes refinement and ordering of an engineering run BOM, operator training, conclusion of any analytical method development work, and creation of an engineering run protocol and draft GMP documentation, such as master batch records, SOPs, and release documents.</span></p></div></div></div><div class="e17391-e18 x-acc-item"><button id="tab-e17391-e18" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e18" data-x-toggle="collapse" data-x-toggleable="e17391-e18"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What is your policy on PIP (People in Plant)?</span></strong></span></span></button><div id="panel-e17391-e18" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e18" data-x-toggleable="e17391-e18" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">BioCentriq employs a hybrid team model. We always welcome people in plant. Clients are encouraged to visit our pilot plant during tech transfer and work alongside our R&D and MSAT teams to help facilitate knowledge share and troubleshoot any challenges that arise as our team strives to scale up or scale out your technologies or otherwise optimize your process for clinical manufacturing. During clinical manufacturing, clients must of course be qualified as needed to enter our GMP facility, but again, our welcome to observe all manufacturing processes, and as appropriate and in accordance with our quality systems, can even operate in the suites with our team. </span></p></div></div></div></div></div></div></div></div><div class="x-section e17391-e19 mdf3-0 mdf3-2 mdf3-3 mdf3-4 mdf3-5"><div class="x-row x-container max width e17391-e20 mdf3-8 mdf3-a mdf3-c mdf3-e"><div class="x-row-inner"><div class="x-col e17391-e21 mdf3-j mdf3-k"><div class="x-text x-text-headline e17391-e22 mdf3-o mdf3-p mdf3-r mdf3-s"><div class="x-text-content"><div class="x-text-content-text"><h2 class="x-text-content-text-primary">BioCentriq's Facilities</h2></div></div></div></div><div class="x-col e17391-e23 mdf3-j mdf3-m"><div class="x-acc e17391-e24 mdf3-t accordion" id="x-acc-e17391-e24"><div class="e17391-e25 x-acc-item"><button id="tab-e17391-e25" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e25" data-x-toggle="collapse" data-x-toggleable="e17391-e25"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;" 9i8="">Is your site registered with the FDA? </span></strong></span></span></button><div id="panel-e17391-e25" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e25" data-x-toggleable="e17391-e25" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">Yes, BioCentriq sites are registered with the FDA. </span></p></div></div></div><div class="e17391-e26 x-acc-item"><button id="tab-e17391-e26" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e26" data-x-toggle="collapse" data-x-toggleable="e17391-e26"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">Do you provide fill and finish services? </span></strong></span></span></button><div id="panel-e17391-e26" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e26" data-x-toggleable="e17391-e26" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">Yes, we currently offer manual and semi-automated fill and finish in bags or vials. We also have partners who can supply automated fill and finish services. </span></p></div></div></div><div class="e17391-e27 x-acc-item"><button id="tab-e17391-e27" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e27" data-x-toggle="collapse" data-x-toggleable="e17391-e27"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What is your capacity for cryopreservation? </span></strong></span></span></button><div id="panel-e17391-e27" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e27" data-x-toggleable="e17391-e27" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">We currently have significant freezer capacity and can always source additional freezers or partner with a third party to meet the needs of your program. </span></p></div></div></div><div class="e17391-e28 x-acc-item"><button id="tab-e17391-e28" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e28" data-x-toggle="collapse" data-x-toggleable="e17391-e28"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What is your largest bioreactor?</span></strong></span></span></button><div id="panel-e17391-e28" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e28" data-x-toggleable="e17391-e28" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">We currently own 2 iCELLis Nanos (max 4m^2), 4 BioSTATs (2L), 2 STR 50s (50L), 1 STR 200 (200L), and 1 iCELLis 500 (500m^2) .</span></p></div></div></div><div class="e17391-e29 x-acc-item"><button id="tab-e17391-e29" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e29" data-x-toggle="collapse" data-x-toggleable="e17391-e29"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">Do you do both suspension and adherent cell culture and what is your related capacity? </span></strong></span></span></button><div id="panel-e17391-e29" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e29" data-x-toggleable="e17391-e29" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">We do adherent cell culture in flasks and bioreactors with a maximum capacity of 500 m^2 in the iCELLis 500. For suspension we can go up to 200L in the STR200.</span></p></div></div></div><div class="e17391-e30 x-acc-item"><button id="tab-e17391-e30" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e30" data-x-toggle="collapse" data-x-toggleable="e17391-e30"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">Have you been audited? </span></strong></span></span></button><div id="panel-e17391-e30" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e30" data-x-toggleable="e17391-e30" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">Yes, we have participated in several client audits. We have yet to have the FDA audit our site, but our team has participated in many FDA audits, and we will be ready when it is required. </span></p></div></div></div></div></div></div></div></div><div class="x-section e17391-e31 mdf3-0 mdf3-2 mdf3-3 mdf3-5 mdf3-6"><div class="x-row x-container max width e17391-e32 mdf3-8 mdf3-a mdf3-c mdf3-f"><div class="x-row-inner"><div class="x-col e17391-e33 mdf3-j mdf3-k"><div class="x-text x-text-headline e17391-e34 mdf3-o mdf3-p mdf3-r mdf3-s"><div class="x-text-content"><div class="x-text-content-text"><h2 class="x-text-content-text-primary">Manufacturing Capability</h2></div></div></div></div><div class="x-col e17391-e35 mdf3-j mdf3-m"><div class="x-acc e17391-e36 mdf3-t accordion" id="x-acc-e17391-e36"><div class="e17391-e37 x-acc-item"><button id="tab-e17391-e37" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e37" data-x-toggle="collapse" data-x-toggleable="e17391-e37"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;" 9i8="">Do you manufacture clinical grade material?</span></strong></span></span></button><div id="panel-e17391-e37" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e37" data-x-toggleable="e17391-e37" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><span style="color: #67686b;">Yes. We manufacture clinical grade drug product and drug substance for use in all phases of clinical trials.</span></div></div></div><div class="e17391-e38 x-acc-item"><button id="tab-e17391-e38" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e38" data-x-toggle="collapse" data-x-toggleable="e17391-e38"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">Can you support commercial manufacturing?</span></strong></span></span></button><div id="panel-e17391-e38" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e38" data-x-toggleable="e17391-e38" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><span style="color: #67686b;">We are currently evolving our systems and facilities and plan to be able to support commercial manufacturing starting in 2025.</span></div></div></div><div class="e17391-e39 x-acc-item"><button id="tab-e17391-e39" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e39" data-x-toggle="collapse" data-x-toggleable="e17391-e39"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">Do you provide cell banking services?</span></strong></span></span></button><div id="panel-e17391-e39" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e39" data-x-toggleable="e17391-e39" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><span style="color: #67686b;">Yes, BioCentriq has experience manufacturing both working and master cell banks for multiple clients using a variety of cell types. All cell banks are fully characterized and compliant with GMP requirements and follow a robust quality assurance process. We regularly produce cell banks in support of manufacturing campaigns and can also provide them as a stand-alone service. </span></div></div></div><div class="e17391-e40 x-acc-item"><button id="tab-e17391-e40" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e40" data-x-toggle="collapse" data-x-toggleable="e17391-e40"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What size are your clean rooms?</span></strong></span></span></button><div id="panel-e17391-e40" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e40" data-x-toggleable="e17391-e40" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><span style="color: #67686b;"><span style="color: #67686b;">We have four clean room manufacturing suites, soon to be five. They range in size from 400 to 1000+ square feet of space available. Please visit our </span>facilities page<span style="color: #67686b;"> for more details.</span></span></div></div></div><div class="e17391-e41 x-acc-item"><button id="tab-e17391-e41" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e41" data-x-toggle="collapse" data-x-toggleable="e17391-e41"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">How do you qualify and train your operators?</span></strong></span></span></button><div id="panel-e17391-e41" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e41" data-x-toggleable="e17391-e41" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><span style="color: #67686b;">All of our operators are trained on standard operating procedures as part of their onboarding to BioCentriq. Before they can operate in a GMP environment, they must be both gown and aseptic qualified. Lastly, before they can be involved in production, all operators go through product specific training and must demonstrate proficiency in the unit operations required to run the process.</span></div></div></div><div class="e17391-e42 x-acc-item"><button id="tab-e17391-e42" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e42" data-x-toggle="collapse" data-x-toggleable="e17391-e42"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What kind of capacity do you have to store our materials?</span></strong></span></span></button><div id="panel-e17391-e42" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e42" data-x-toggleable="e17391-e42" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><span style="color: #67686b;">BioCentriq has both on-site and off-site storage available providing us with adequate capacity to support materials required for production as well as short to longer-term storage solutions for finished products.</span></div></div></div></div></div></div></div></div><div class="x-section e17391-e43 mdf3-0 mdf3-2 mdf3-3 mdf3-4 mdf3-5"><div class="x-row x-container max width e17391-e44 mdf3-8 mdf3-a mdf3-c mdf3-g"><div class="x-row-inner"><div class="x-col e17391-e45 mdf3-j mdf3-k"><div class="x-text x-text-headline e17391-e46 mdf3-o mdf3-p mdf3-r mdf3-s"><div class="x-text-content"><div class="x-text-content-text"><h2 class="x-text-content-text-primary">Process Development Capability</h2></div></div></div></div><div class="x-col e17391-e47 mdf3-j mdf3-m"><div class="x-acc e17391-e48 mdf3-t accordion" id="x-acc-e17391-e48"><div class="e17391-e49 x-acc-item"><button id="tab-e17391-e49" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e49" data-x-toggle="collapse" data-x-toggleable="e17391-e49"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;" 9i8="">Where do you do your process development work?</span></strong></span></span></button><div id="panel-e17391-e49" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e49" data-x-toggleable="e17391-e49" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">Our team works out of our pilot plant facility, which is located in South Brunswick, NJ.</span></p></div></div></div><div class="e17391-e50 x-acc-item"><button id="tab-e17391-e50" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e50" data-x-toggle="collapse" data-x-toggleable="e17391-e50"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What phases of process development work do you support?</span></strong></span></span></button><div id="panel-e17391-e50" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e50" data-x-toggleable="e17391-e50" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content">The BioCentriq team has worked on all stages of product development including small-scale projects and experiments to support preclinical evaluation and readiness studies all the way to the development of processes that will support cGMP manufacturing and prepare our clients for commercial readiness. </div></div></div><div class="e17391-e51 x-acc-item"><button id="tab-e17391-e51" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e51" data-x-toggle="collapse" data-x-toggleable="e17391-e51"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What type of products is your process development team capable of working on? </span></strong></span></span></button><div id="panel-e17391-e51" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e51" data-x-toggleable="e17391-e51" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content">Our team works on a variety of cell therapy process development and optimization projects. We've worked on both allogeneic and autologous cell therapy products as well as optimizing processes to support both upstream and downstream processing. In addition, we work on process development projects that demonstrate the application of innovative and novel technologies provided by leaders in the industry.</div></div></div><div class="e17391-e52 x-acc-item"><button id="tab-e17391-e52" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e52" data-x-toggle="collapse" data-x-toggleable="e17391-e52"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">How do you price your process development projects?</span></strong></span></span></button><div id="panel-e17391-e52" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e52" data-x-toggleable="e17391-e52" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p>We are flexible in how we scope and price our process development work, and in general, we determine the appropriate level of activity required to meet your objectives and agree on the deliverables and reports that will be provided to demonstrate the outcomes of those activities.</p></div></div></div></div></div></div></div></div><div class="x-section e17391-e53 mdf3-0 mdf3-2 mdf3-3 mdf3-5 mdf3-6"><div class="x-row x-container max width e17391-e54 mdf3-8 mdf3-a mdf3-c mdf3-h"><div class="x-row-inner"><div class="x-col e17391-e55 mdf3-j mdf3-k"><div class="x-text x-text-headline e17391-e56 mdf3-o mdf3-p mdf3-r mdf3-s"><div class="x-text-content"><div class="x-text-content-text"><h2 class="x-text-content-text-primary">Quality & Compliance Programs</h2></div></div></div></div><div class="x-col e17391-e57 mdf3-j mdf3-m"><div class="x-acc e17391-e58 mdf3-t accordion" id="x-acc-e17391-e58"><div class="e17391-e59 x-acc-item"><button id="tab-e17391-e59" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e59" data-x-toggle="collapse" data-x-toggleable="e17391-e59"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;" 9i8="">Have you been audited?</span></strong></span></span></button><div id="panel-e17391-e59" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e59" data-x-toggleable="e17391-e59" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><span style="color: #67686b;"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW87147603 BCX8"><span class="NormalTextRun SCXW87147603 BCX8">Yes, we have </span><span class="NormalTextRun SCXW87147603 BCX8">participated</span><span class="NormalTextRun SCXW87147603 BCX8"> in several client audits. We have yet to have the FDA audit our site, but our team has participated </span><span class="NormalTextRun SCXW87147603 BCX8">in many</span><span class="NormalTextRun SCXW87147603 BCX8"> FDA </span><span class="NormalTextRun SCXW87147603 BCX8">audits,</span><span class="NormalTextRun SCXW87147603 BCX8"> and we will be ready when </span><span class="NormalTextRun SCXW87147603 BCX8">it is required.</span></span><span class="EOP SCXW87147603 BCX8" data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}"> </span></span></div></div></div><div class="e17391-e60 x-acc-item"><button id="tab-e17391-e60" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e60" data-x-toggle="collapse" data-x-toggleable="e17391-e60"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">Has BioCentriq contributed to IND submissions? </span></strong></span></span></button><div id="panel-e17391-e60" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e60" data-x-toggleable="e17391-e60" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content">BioCentriq has supported our clients in the development and creation of their IND submissions by providing content required for the CMC portion and performing IND enabling studies on their behalf.</div></div></div><div class="e17391-e61 x-acc-item"><button id="tab-e17391-e61" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e61" data-x-toggle="collapse" data-x-toggleable="e17391-e61"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">Do you use a digital quality management system (QMS)?</span></strong></span></span></button><div id="panel-e17391-e61" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e61" data-x-toggleable="e17391-e61" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content">BioCentriq has deployed MasterControl as its quality management solution and we use this platform to <span>effectively manage quality events, processes and documentation.</span></div></div></div><div class="e17391-e62 x-acc-item"><button id="tab-e17391-e62" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e62" data-x-toggle="collapse" data-x-toggleable="e17391-e62"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What are your QC and analytical testing capabilities?</span></strong></span></span></button><div id="panel-e17391-e62" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e62" data-x-toggleable="e17391-e62" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p>Our analytical testing capabilities include the following:</p> <ul> <li>Dose: Cell count & viability, viral vector titer (ddPCR, ELISA, flow cytometry)</li> <li>Identity: Cell marker identification, gene expression, SDS-PAGE, Western blot, flow cytometry</li> <li>Potency Testing: Proliferation, cytotoxicity, ELISA, enzyme activity, viral vector titer</li> <li>Purity Testing: Identification, residual host cell DNA, residual host protein</li> <li>Microbiology: Endotoxin, sterility, and bioburden testing</li> </ul></div></div></div></div></div></div></div></div><div class="x-section e17391-e63 mdf3-0 mdf3-2 mdf3-5 mdf3-6 mdf3-7"><div class="x-row x-container max width e17391-e64 mdf3-8 mdf3-a mdf3-c mdf3-i"><div class="x-row-inner"><div class="x-col e17391-e65 mdf3-j mdf3-k"><div class="x-text x-text-headline e17391-e66 mdf3-o mdf3-p mdf3-r mdf3-s"><div class="x-text-content"><div class="x-text-content-text"><h2 class="x-text-content-text-primary">Workforce Development Capability</h2></div></div></div></div><div class="x-col e17391-e67 mdf3-j mdf3-m"><div class="x-acc e17391-e68 mdf3-t accordion" id="x-acc-e17391-e68"><div class="e17391-e69 x-acc-item"><button id="tab-e17391-e69" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e69" data-x-toggle="collapse" data-x-toggleable="e17391-e69"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;" 9i8="">Where does training take place?</span></strong></span></span></button><div id="panel-e17391-e69" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e69" data-x-toggleable="e17391-e69" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><p><span style="color: #67686b;">BioCentriq can offer training in our facilities on the campus of the New Jersey Institute of Technology which is in Newark, NJ, just outside of New York City, conveniently located within minutes of Newark International Airport and public transportation. We can also train in our South Brunswick location for trainees coming from Central or South Jersey or Philadelphia. </br> </br> We can also come to you and train at your site. Our virtual instructor-led training, self-paced training and training programs which utilized augmented or virtual reality can be held anywhere, anytime! </span></p></div></div></div><div class="e17391-e70 x-acc-item"><button id="tab-e17391-e70" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e70" data-x-toggle="collapse" data-x-toggleable="e17391-e70"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">What topics can you train on?</span></strong></span></span></button><div id="panel-e17391-e70" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e70" data-x-toggleable="e17391-e70" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content">We can train on any topic related to the development and manufacturing of cell therapies. We regularly train on topics related to aseptic processing, unit operations required to run a process, gowning, analytical methods, quality control and assurance, regulatory guidelines and more.</div></div></div><div class="e17391-e71 x-acc-item"><button id="tab-e17391-e71" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e71" data-x-toggle="collapse" data-x-toggleable="e17391-e71"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">Do you offer hands-on training?</span></strong></span></span></button><div id="panel-e17391-e71" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e71" data-x-toggleable="e17391-e71" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content">Yes, our training labs are fully equipped with BSCs and other equipment and space needed to conduct hands-on training to verify that your employees can gown or demonstrate proficiency in specific unit operations, manipulations and techniques required to run your process.</div></div></div><div class="e17391-e72 x-acc-item"><button id="tab-e17391-e72" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e72" data-x-toggle="collapse" data-x-toggleable="e17391-e72"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">Do you provide executive level training courses?</span></strong></span></span></button><div id="panel-e17391-e72" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e72" data-x-toggleable="e17391-e72" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content">BioCentriq does provide executive level training courses designed to help your executives who are transitioning from another industry or sector of life sciences better understand the nuances of the cell therapy industry. Examples might include helping them gain a better understanding of the impact working with cellular materials have on the manufacturing process or what terms and conditions become critical in the contracts you put in place with your CDMO/CMO/CRO partners.</div></div></div><div class="e17391-e73 x-acc-item"><button id="tab-e17391-e73" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e73" data-x-toggle="collapse" data-x-toggleable="e17391-e73"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">Do you offer employee qualification services?</span></strong></span></span></button><div id="panel-e17391-e73" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e73" data-x-toggleable="e17391-e73" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content">We are in the process of building that capability but often find that our clients ask us to stop short of performing and documenting qualification and prefer to manage that process within their own systems.</div></div></div><div class="e17391-e74 x-acc-item"><button id="tab-e17391-e74" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e74" data-x-toggle="collapse" data-x-toggleable="e17391-e74"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">Can you train on our manufacturing protocols and procedures?</span></strong></span></span></button><div id="panel-e17391-e74" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e74" data-x-toggleable="e17391-e74" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW115283955 BCX8"><span class="NormalTextRun SCXW115283955 BCX8">Absolutely. You can transfer your protocols and procedures to our trainers and qualify them, in essence, train and qualify our trainers, and then they will in turn train your employees and verify their proficiency at which point, either of us can qualify them, again, depending on the constraints of your quality system.</span></span><span class="EOP SCXW115283955 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":259}"> </span></div></div></div><div class="e17391-e75 x-acc-item"><button id="tab-e17391-e75" class="x-acc-header" role="button" type="button" aria-expanded="false" aria-controls="panel-e17391-e75" data-x-toggle="collapse" data-x-toggleable="e17391-e75"><span class="x-acc-header-content"><span class="x-acc-header-indicator">▸</span><span class="x-acc-header-text"><strong><span style="color: #126e8c;">How much do your training programs cost?</span></strong></span></span></button><div id="panel-e17391-e75" role="region" aria-hidden="true" aria-labelledby="tab-e17391-e75" data-x-toggleable="e17391-e75" data-x-toggle-collapse="1" class="x-collapsed"><div class="x-acc-content">The cost of our training programs varies depending on the scope of the services delivered. 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