{"id":3563,"date":"2021-09-09T11:25:18","date_gmt":"2021-09-09T11:25:18","guid":{"rendered":"https:\/\/www.biolyotech.com\/?page_id=3563"},"modified":"2021-10-05T14:40:58","modified_gmt":"2021-10-05T14:40:58","slug":"transfer-in-or-in-house-development-of-cell-based-assays","status":"publish","type":"page","link":"https:\/\/www.biolyotech.com\/index.php\/live-bacterial-product-services\/transfer-in-or-in-house-development-of-cell-based-assays\/","title":{"rendered":"Transfer in or in House Development of Cell Based Assays"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-0 fusion_builder_column_inner_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>Most Live Bacterial Products have an activity <em>in vivo<\/em> that is difficult to measure in an <em>in vitro<\/em> test. Depending on the nature of the LBP, a simple CFU count can be used as a potency assay, but if specific genes are inserted that are supposed to perform a specific activity, or if an activity of the LBP is known a test can be developed to verify that this activity is intact in the Drug Product. This circumvents showing the overall effect of the LBP in an animal model since the reproducibility and discerning power of an animal model is generally low. It remains to be seen if these characterization tests need to become release tests for GMP material, but these tests can be vital to support an IND or IMPD submission.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-1 fusion_builder_column_inner_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"633\" height=\"560\" src=\"https:\/\/www.biolyotech.com\/wp-content\/uploads\/2021\/09\/last.jpg\" alt class=\"img-responsive wp-image-3894\" srcset=\"https:\/\/www.biolyotech.com\/wp-content\/uploads\/2021\/09\/last-200x177.jpg 200w, https:\/\/www.biolyotech.com\/wp-content\/uploads\/2021\/09\/last-400x354.jpg 400w, https:\/\/www.biolyotech.com\/wp-content\/uploads\/2021\/09\/last-600x531.jpg 600w, https:\/\/www.biolyotech.com\/wp-content\/uploads\/2021\/09\/last.jpg 633w\" sizes=\"(max-width: 640px) 100vw, 600px\" \/><\/span><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":3544,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"side-navigation.php","meta":{"footnotes":""},"class_list":["post-3563","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.biolyotech.com\/index.php\/wp-json\/wp\/v2\/pages\/3563","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.biolyotech.com\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.biolyotech.com\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.biolyotech.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.biolyotech.com\/index.php\/wp-json\/wp\/v2\/comments?post=3563"}],"version-history":[{"count":7,"href":"https:\/\/www.biolyotech.com\/index.php\/wp-json\/wp\/v2\/pages\/3563\/revisions"}],"predecessor-version":[{"id":3953,"href":"https:\/\/www.biolyotech.com\/index.php\/wp-json\/wp\/v2\/pages\/3563\/revisions\/3953"}],"up":[{"embeddable":true,"href":"https:\/\/www.biolyotech.com\/index.php\/wp-json\/wp\/v2\/pages\/3544"}],"wp:attachment":[{"href":"https:\/\/www.biolyotech.com\/index.php\/wp-json\/wp\/v2\/media?parent=3563"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}