{"id":18,"date":"2019-04-23T00:02:31","date_gmt":"2019-04-23T00:02:31","guid":{"rendered":"https:\/\/www.cutaquigus.com\/hcp\/why-cutaquig\/manufacturing-pathogen-safety\/"},"modified":"2025-01-29T00:31:10","modified_gmt":"2025-01-29T00:31:10","slug":"manufacturing-pathogen-safety","status":"publish","type":"page","link":"https:\/\/cutaquigusa.com\/hcp\/why-cutaquig\/manufacturing-pathogen-safety\/","title":{"rendered":"Cutaquig SCIg | Safety and Manufacturing"},"content":{"rendered":"\n<h2>Cutaquig manufacturing and purification process<sup>1-3<\/sup><\/h2>\n<section id=\"block-1a\" class=\"block block--content-with-full-image alignfull\">\n<div class=\"block__content-with-full-image-wrapper alignwide \">\n<div class=\"block__image\">\n      <a href=\"https:\/\/cutaquigusa.com\/hcp\/wp-content\/uploads\/sites\/2\/2020\/02\/pathogetn_safety_chart_1024x817.jpg\" class=\"enlarge\"><br>\n<img width=\"1024\" height=\"817\" alt=\"Pathogen safety explanation chart\" class=\"block__img initial loaded\" data-original=\"https:\/\/cutaquigusa.com\/hcp\/wp-content\/uploads\/sites\/2\/2020\/02\/pathogetn_safety_chart_1024x817.jpg\"><br>\n<\/a>\n    <\/div>\n<div class=\"block__caption\"><\/div>\n<div class=\"block__content\">\n<p><strong>Cutaquig contains all 4 subclasses of IgG, with a percentage distribution equivalent to the one found in normal plasma.<\/strong><\/p>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"block-2a\" class=\"block block--content alignfull\">\n<div class=\"block__content-wrapper alignwide \">\n<div class=\"aligndefault\">\n<ul class=\"slick arrow-v2\">\n<li>Cutaquig is made from large pools of donated plasma which go through a rigorous purification process for the inactivation and removal of viruses<\/li>\n<li>Other precautions against viral transmission include: selection of plasma donors, screening of donations and plasma pool, as well as final product testing for viruses<\/li>\n<li>Cutaquig is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with a Solvent\/Detergent (S\/D), and incubation at low pH.<\/li>\n<\/ul><\/div>\n<\/div>\n<\/section>\n<section id=\"block-3a\" class=\"block block--content alignfull\">\n<div class=\"block__content-wrapper alignwide \">\n<div class=\"aligndefault\">\n<h2>Viral removal and inactivation<sup>1<\/sup><\/h2>\n<p class=\"h3\">Cutaquig manufacturing process shows significant viral reduction within in <em>vitro<\/em> studies.<\/p>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"block-4a\" class=\"block block--content alignfull\">\n<div class=\"block__content-wrapper alignwide \">\n<div class=\"aligndefault\">\n<div class=\"responsive-table\">\n<div class=\"responsive-table__inner\">\n<table border=\"1\">\n<tbody>\n<tr>\n<th class=\"text-center\" rowspan=\"3\"><strong>Production Step<\/strong><\/th>\n<th class=\"text-center\" colspan=\"5\">In vitro reduction factor [log<sub>10<\/sub>]<\/th>\n<\/tr>\n<tr class=\"table-row-first-col-has-border\">\n<th class=\"text-center\" colspan=\"3\"><strong>Enveloped Viruses<\/strong><\/th>\n<th class=\"text-center\" colspan=\"2\"><strong>Non-Enveloped Viruses<\/strong><\/th>\n<\/tr>\n<tr class=\"table-row-first-col-has-border\">\n<th class=\"text-center\"><strong>HIV-1<\/strong><\/th>\n<th class=\"text-center\"><strong>PRV<\/strong><\/th>\n<th class=\"text-center\"><strong>SBV<\/strong><\/th>\n<th class=\"text-center\"><strong>MEV<\/strong><\/th>\n<th class=\"text-center\"><strong>PPV<\/strong><\/th>\n<\/tr>\n<tr>\n<th class=\"text-center\"><strong>Cold ethanol fractionation<\/strong><\/th>\n<td class=\"text-center\">&ge; 4.81<\/td>\n<td class=\"text-center\">&ge; 6.28<\/td>\n<td class=\"text-center\">&ge; 7.13<\/td>\n<td class=\"text-center\">&ge; 7.13<\/td>\n<td class=\"text-center\">&ge; 6.53<\/td>\n<\/tr>\n<tr class=\"text-center\">\n<th class=\"text-center\"><strong>S\/D treatment<\/strong><\/th>\n<td class=\"text-center\">&ge; 4.93<\/td>\n<td class=\"text-center\">5.23<\/td>\n<td class=\"text-center\">&ge; 6.77<\/td>\n<td class=\"text-center\">n.a.<\/td>\n<td class=\"text-center\">n.a.<\/td>\n<\/tr>\n<tr>\n<th class=\"text-center\">pH 4 treatment<\/th>\n<td class=\"text-center\">&ge; 4.33<\/td>\n<td class=\"text-center\">&ge; 6.71<\/td>\n<td class=\"text-center\">6.71<\/td>\n<td class=\"text-center\">5.07<\/td>\n<td class=\"text-center\">&lt; 1<sup>*<\/sup><\/td>\n<\/tr>\n<tr>\n<th class=\"text-center\">Global reduction factor<\/th>\n<td class=\"text-center\">&ge; 14.07<\/td>\n<td class=\"text-center\">&ge; 18.22<\/td>\n<td class=\"text-center\">&ge; 20.61<\/td>\n<td class=\"text-center\">&ge; 12.20<\/td>\n<td class=\"text-center\">&ge; 6.53<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<\/div>\n<p class=\"small\"><sup>*<\/sup>Not calculated for global LRF.<br>HIV-1: Human Immunodeficiency Virus &ndash; 1; PRV: Pseudorabies Virus, model virus for e.g. Hepatitis B Virus (HBV); SBV: Sindbis Virus model virus for Hepatitis C Virus (HCV); MEV: Mouse Encephalomyelitis Virus, model virus for Human Parvovirus B19; PPV: Porcine Parvovirus, model virus for Hepatitis A Virus (HAV).<\/p>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"block-5a\" class=\"block block--cta-with-wysiwyg-and-image alignfull\">\n<div class=\"alignwide\">\n<div class=\"cta-banner cta-banner--fallback-bg\">\n<div class=\"cta-banner__body\">\n<div class=\"cta-banner__body-inner\">\n<div class=\"cta-banner__icon\">\n            <img data-original=\"https:\/\/cutaquigusa.com\/wp-content\/uploads\/2019\/12\/notepad-pink.png\">\n          <\/div>\n<h3 class=\"h3\">Review the clinical efficacy and safety of cutaquig here.<\/h3>\n<p>          <a href=\"https:\/\/cutaquigusa.com\/hcp\/evidence\/\" class=\"action action--fa-angle-right\">Learn More <i class=\"fa fa-angle-right\"><\/i><\/a>\n        <\/p><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"block-6\" class=\"block block--content alignfull\">\n<div class=\"block__content-wrapper alignwide \">\n<div class=\"aligndefault\">\n<h5>References:<\/h5>\n<ol>\n<li class=\"small\">Cutaquig Full Prescribing Information. Paramus, NJ: Octapharma; rev October 2021.<\/li>\n<li class=\"small\">Octapharma, Data on File.<\/li>\n<li class=\"small\">Buchacher A, Kaar W. Intravenous immunoglobulin G from human plasma&ndash; purification concepts and important quality criteria. In: Bertolini J, Goss N, Curling J, eds. Production of Plasma Proteins for Therapeutic Use. Hoboken, NJ: John Wiley &amp; Sons, Inc; 2013.<\/li>\n<\/ol><\/div>\n<\/div>\n<\/section>\n\n","protected":false},"excerpt":{"rendered":"<p>Cutaquig manufacturing and purification process1-3 Cutaquig contains all 4 subclasses of IgG, with a percentage distribution equivalent to the one&#8230;<\/p>\n","protected":false},"author":29,"featured_media":0,"parent":12,"menu_order":4,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-18","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>SCIg Safety and Manufacturing | cutaquig\u00ae<\/title>\n<meta name=\"description\" content=\"Learn about the steps we take for pathogen safety and manufacturing for cutaquig\u00ae (Immune Globulin Subcutaneous [Human]-hipp, 16.5% solution). 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