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We certify that mammalian cell lines are free of mycoplasma and bacterial contamination.<p>For risk mitigation, we store a portion of our clients’ MCBs and WCBs offsite under cGMP conditions, either in vapour phase of liquid nitrogen vessels or in deep freezers (-80º C), with a monitoring system to confirm proper liquid nitrogen levels and freezer temperatures at all times. Banks are separated and stored in individual freezers at two different locations to prevent loss due to freezer malfunction, and a fully redundant backup system ensures the security of the storage facility.</p><br><h3 class="text-purplemain bold mb-15">Cell Banking Capabilities</h3><ul class=grey-bullet-list><li>Master and Working cell bank manufacturing for microbial and mammalian cultures <hr class=purple-line><li>Characterization and testing of MCBs and WCBs according to ICH Q5B, Q5D, Q5A, Q6B and Q7 guidelines <hr class=purple-line><li>Aseptic cell banking within certified laminar flow II biosafety level cabinets with Class A high-efficiency particulate air (HEPA) <hr class=purple-line><li>Stability studies <hr class=purple-line></ul></div></div></div></div></div></section></div> <div class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module"data-hs-cos-general-type=widget data-hs-cos-type=module id=hs_cos_wrapper_widget_1557417585240><section class=card-container-module><div class=container><div class="row justify-content-between"><div class="col-md-4 col-sm-12 card-module px-3 text-white d-flex flex-column justify-content-between single-card"><div style="padding-right: 45px"class=pl-2><p style="margin-top: 69px"class=light><div class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_inline_text"data-hs-cos-field=card_label data-hs-cos-general-type=widget data-hs-cos-type=inline_text id=hs_cos_wrapper_widget_1557417585240_>cGMP MANUFACTURING</div><p><h3><b> <div class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_inline_text"data-hs-cos-field=card_title data-hs-cos-general-type=widget data-hs-cos-type=inline_text id=hs_cos_wrapper_widget_1557417585240_>Drug Substance</div> </b></h3><p class=light><div class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_inline_text"data-hs-cos-field=card_text data-hs-cos-general-type=widget data-hs-cos-type=inline_text id=hs_cos_wrapper_widget_1557417585240_>With industry-leading expertise and state-of-the-art single-use equipment, we can take your API from concept to commercialization, all within our modern facilities</div><p></p><a class="link-with-arrow bold"href=/cgmp-manufacturing/drug-substance?hsLang=en> Learn More </a></div><div class="row w-100 justify-content-end mb-4"><img style="height: 104px;width:104px"src=https://www.northwaybiotech.com/hubfs/website-images-2019/icon%20cGMP_Drug_Substance%20.svg></div></div><div class="col-md-8 col-sm-12"><div class="row pl-3"><div class="d-flex flex-column"><div class="card-module text-white d-flex flex-column justify-content-between double-card"style=width:380px;><div style="padding-right: 45px"class=pl-4><h4 style="margin-top: 69px;"class=light><div class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_inline_text"data-hs-cos-field=card_label data-hs-cos-general-type=widget data-hs-cos-type=inline_text id=hs_cos_wrapper_widget_1557417585240_>cGMP MANUFACTURING</div></h4><h3><b> <div class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_inline_text"data-hs-cos-field=card_title data-hs-cos-general-type=widget data-hs-cos-type=inline_text id=hs_cos_wrapper_widget_1557417585240_>Drug Product</div> </b></h3><p class=light><div class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_inline_text"data-hs-cos-field=card_text data-hs-cos-general-type=widget data-hs-cos-type=inline_text id=hs_cos_wrapper_widget_1557417585240_>From formulation development to sterile fill-finish, Northway Biotech supports your product’s development through every step of the journey.</div><p></p><a class="link-with-arrow bold"href=/cgmp-manufacturing/drug-product?hsLang=en> Learn More </a></div><div class="row w-100 justify-content-end mb-4 pr-4"><img src=https://www.northwaybiotech.com/hubfs/website-images-2019/icon%20cGMP_Drug_Product%20.svg></div></div></div><div class=double-card-image-parent 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