{"id":4278,"date":"2025-03-10T08:45:00","date_gmt":"2025-03-10T08:45:00","guid":{"rendered":"http:\/\/biogroupvietnam-worldpress.local\/2025\/08\/18\/regulations-on-the-use-of-fbs-hpl\/"},"modified":"2025-09-29T14:00:15","modified_gmt":"2025-09-29T07:00:15","slug":"nhung-thay-doi-ve-quy-dinh-trong-viec-su-dung-fbs-va-hpl","status":"publish","type":"post","link":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/","title":{"rendered":"Updates on FBS and HPL usage regulations"},"content":{"rendered":"<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\">As the field of cell and gene therapy advances, regulatory agencies are tightening the guidelines surrounding the use of fetal bovine serum (FBS) and human platelet lysate (HPL). Agencies such as the FDA and EMA are currently emphasizing the use of materials that are free from animal or human sources. Their focus is on improving the safety, consistency, and reproducibility of cell therapy products.<\/span><\/p>\n<p>&nbsp;<\/p>\n<figure class=\"image\"><img fetchpriority=\"high\" decoding=\"async\" style=\"aspect-ratio: 2240\/1260;\" src=\"https:\/\/biogroupvietnam.com\/uploads\/CellCor\u2122 MSC CD AOF chuy\u1ec3n \u0111\u1ed5i nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o.png\" alt=\"CellCor\u2122 MSC CD AOF supports the transition to cell culture\" width=\"2240\" height=\"1260\" \/><figcaption><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\"><i>CellCor\u2122 MSC CD AOF supports the transition to cell culture<\/i><\/span><\/figcaption><\/figure>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_80 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#Regulations_on_FBS_and_HPL_usage\" >Regulations on FBS and HPL usage<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#FDA_%E2%80%93_CMC_guidelines_for_human_gene_therapy_2020\" >FDA \u2013 CMC guidelines for human gene therapy (2020)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#ICH_Q5AR2_%E2%80%93_Virus_safety_evaluation_2024\" >ICH Q5A(R2) \u2013 Virus safety evaluation (2024)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#EMA_%E2%80%93_Non-clinicalclinical_quality_requirements_for_cell_therapy_Draft_2019\" >EMA \u2013 Non-clinical\/clinical quality requirements for cell therapy (Draft, 2019)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#EMA_%E2%80%93_Guidelines_for_human_cell-based_medicinal_products_2008\" >EMA \u2013 Guidelines for human cell-based medicinal products (2008)<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#The_transition_to_CD_and_AOF_culture_media\" >The transition to CD and AOF culture media<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#Are_you_ready_for_the_transition_in_cell_culture\" >Are you ready for the transition in cell culture?&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#Appendix\" >Appendix<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Regulations_on_FBS_and_HPL_usage\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\"><strong>Regulations on FBS and HPL usage<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"FDA_%E2%80%93_CMC_guidelines_for_human_gene_therapy_2020\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 16pt;\"><strong>FDA \u2013 CMC guidelines for human gene therapy (2020)<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\">Materials of animal origin can introduce unintended agents. This leads to lot-to-lot variations, impacting product consistency. Consider using non-animal-derived reagents (e.g., serum-free media or recombinant proteases). If serum is used, it must be gamma-irradiated to reduce the risk of contamination.&nbsp;<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"ICH_Q5AR2_%E2%80%93_Virus_safety_evaluation_2024\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 16pt;\"><strong>ICH Q5A(R2) \u2013 Virus safety evaluation (2024)<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\">Emphasizes minimizing the use of materials derived from humans and animals to reduce the risk of viral contamination. It is recommended to avoid using human serum, bovine serum, or porcine trypsin in manufacturing processes.<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"EMA_%E2%80%93_Non-clinicalclinical_quality_requirements_for_cell_therapy_Draft_2019\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 16pt;\"><strong>EMA \u2013 Non-clinical\/clinical quality requirements for cell therapy (Draft, 2019)<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\">It is recommended to avoid animal-derived reagents and opt instead for non-animal-derived reagents with defined components. This helps minimize unexpected agents, reducing the need for additional testing.&nbsp;<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"EMA_%E2%80%93_Guidelines_for_human_cell-based_medicinal_products_2008\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 16pt;\"><strong>EMA \u2013 Guidelines for human cell-based medicinal products (2008)<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\">Encourages the use of synthetic substitutes for serum whenever possible. If bovine serum is used, gamma-irradiated serum or synthetic media should be considered for use.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"The_transition_to_CD_and_AOF_culture_media\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\"><strong>The transition to CD and AOF culture media<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\">Regulatory push is not only toward adopting Xeno-Free solutions but also supporting materials that are \u201cchemically defined\u201d (CD) and \u201canimal-origin-free\u201d (AOF) for safer and more consistent manufacturing processes.<\/span><\/p>\n<ul>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\"><strong>Chemically defined (CD) media<\/strong>: Provides better reproducibility and regulatory compliance by using components with fully defined ingredients.&nbsp;<\/span><\/li>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\"><strong>Animal-origin-free (AOF) media<\/strong>: Eliminates the risk of contamination from animal-derived substances, enhancing the safety of the product.<\/span><\/li>\n<\/ul>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\">To meet the highest safety and quality standards in cell and gene therapy, the transition to CD\/AOF materials is no longer optional but a necessity.&nbsp;<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Are_you_ready_for_the_transition_in_cell_culture\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\"><strong>Are you ready for the transition in cell culture?&nbsp;<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\">Culturing cells in CD\/AOF media aligns with the new international standards to ensure safety and compliance in research and production. However, with so many CD\/AOF media products available, which one is the most efficient?&nbsp;<\/span><a href=\"https:\/\/www.xcell.co.kr\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 11pt;\">Xcell Therapeutics<\/span><\/a><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\"> specializes in the production of cell culture media with&nbsp;<\/span><a href=\"https:\/\/biogroupvietnam.com\/san-pham\/moi-truong-cellcor-cd-msc-aof\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 11pt;\">CellCor\u2122 MSC CD AOF<\/span><\/a><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\">, which fully meets the rigorous requirements for research. The CellCor\u2122 MSC CD AOF culture media will help researchers and biotech companies adapt more easily to this transition.<\/span><\/p>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\">Biogroup Vietnam is always ready to support you in adapting to increasingly stringent international regulations. Contact us for consultation on products and solutions for cell culture transition.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\"> &nbsp;<\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 13.999999999999998pt;\"><strong>Contact information:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\"><strong>Website:<\/strong><\/span><a href=\"https:\/\/biogroupvietnam.com\/public\/lien-he\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">&nbsp;<\/span><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 12pt;\">https:\/\/biogroupvietnam.com\/public\/lien-he<\/span><\/a><\/li>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\"><strong>Hotline:<\/strong> +84 963 621 421&nbsp;<\/span><\/li>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\"><strong>Email:<\/strong>&nbsp;<\/span><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 12pt;\">info@biogroupvietnam.vn<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Appendix\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\"><strong>Appendix<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure class=\"image\"><img decoding=\"async\" style=\"aspect-ratio: 602\/403;\" src=\"https:\/\/lh7-rt.googleusercontent.com\/docsz\/AD_4nXet181UvbOE6MfTxv6OngB7BT6y_bEO6Mxvt-nItln5y0P2dYgCrktMjh5KNx4CWuVIJEOlAq0-m1Mo7Ils0psLdsiydKpmae61_J9sj2PCqa-NUxKtI8PMOTMSvgM-jvDOIoLUcA?key=l1G_CJwmhuBFcZRshTMYhg\" alt=\"Market trends after new regulations for cell or gene therapy development (Source: Xcell Therapeutics)\" width=\"602\" height=\"403\" \/><figcaption><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\"><i>Market trends after new regulations for cell or gene therapy development (Source: Xcell Therapeutics)<\/i><\/span><\/figcaption><\/figure>\n<p style=\"text-align: center;\">&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>As the field of cell and gene therapy advances, regulatory agencies are tightening the guidelines surrounding the use of fetal bovine serum (FBS) and human platelet lysate (HPL). Agencies such as the FDA and EMA are currently emphasizing the use of materials that are free from animal or human sources. Their focus is on improving<\/p>\n<div class=\"klb-readmore post-buttons\"><a class=\"button rounded primary\" href=\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/\">Read More <i class=\"klbth-icon-right-arrow\"><\/i><\/a><\/div>\n","protected":false},"author":1,"featured_media":6046,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[19],"tags":[],"class_list":["post-4278","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Updates on FBS and HPL usage regulations<\/title>\n<meta name=\"description\" content=\"As the field of cell and gene therapy advances, regulatory agencies are tightening the guidelines surrounding the use of fetal bovine serum (FBS) and human platelet lysate (HPL). Agencies such as the FDA and EMA are currently emphasizing the use of materials that are free from animal or human sources. Their focus is on improving&hellip;\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/As%20the%20field%20of%20cell%20and%20gene%20therapy%20advances,%20regulatory%20agencies%20are%20tightening%20the%20guidelines%20surrounding%20the%20use%20of%20fetal%20bovine%20serum%20(FBS)%20and%20human%20platelet%20lysate%20(HPL).%20Agencies%20such%20as%20the%20FDA%20and%20EMA%20are%20currently%20emphasizing%20the%20use%20of%20materials%20that%20are%20free%20from%20animal%20or%20human%20sources.%20Their%20focus%20is%20on%20improving&hellip;\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Updates on FBS and HPL usage regulations\" \/>\n<meta property=\"og:description\" content=\"As the field of cell and gene therapy advances, regulatory agencies are tightening the guidelines surrounding the use of fetal bovine serum (FBS) and human platelet lysate (HPL). Agencies such as the FDA and EMA are currently emphasizing the use of materials that are free from animal or human sources. Their focus is on improving&hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/\" \/>\n<meta property=\"og:site_name\" content=\"Biogroup Vietnam\" \/>\n<meta property=\"article:published_time\" content=\"2025-03-10T08:45:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-29T07:00:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/08\/CellCor\u2122-MSC-CD-AOF-ho-tro-chuyen-doi-nuoi-cay-te-bao-avt-1-1.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1600\" \/>\n\t<meta property=\"og:image:height\" content=\"1229\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\/\/biogroupvietnam.com\/vi\/#\/schema\/person\/78a1c640012e6e7bc2bdf0d0fbffea95\"},\"headline\":\"Updates on FBS and HPL usage regulations\",\"datePublished\":\"2025-03-10T08:45:00+00:00\",\"dateModified\":\"2025-09-29T07:00:15+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/\"},\"wordCount\":1238,\"image\":{\"@id\":\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/08\/CellCor\u2122-MSC-CD-AOF-ho-tro-chuyen-doi-nuoi-cay-te-bao-avt-1-1.webp\",\"articleSection\":[\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/\",\"url\":\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/\",\"name\":\"C\u1eadp nh\u1eadt quy \u0111\u1ecbnh s\u1eed d\u1ee5ng FBS v\u00e0 HPL theo ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf\",\"isPartOf\":{\"@id\":\"https:\/\/biogroupvietnam.com\/vi\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/08\/CellCor\u2122-MSC-CD-AOF-ho-tro-chuyen-doi-nuoi-cay-te-bao-avt-1-1.webp\",\"datePublished\":\"2025-03-10T08:45:00+00:00\",\"dateModified\":\"2025-09-29T07:00:15+00:00\",\"author\":{\"@id\":\"https:\/\/biogroupvietnam.com\/vi\/#\/schema\/person\/78a1c640012e6e7bc2bdf0d0fbffea95\"},\"description\":\"C\u1eadp nh\u1eadt quy \u0111\u1ecbnh s\u1eed d\u1ee5ng FBS v\u00e0 HPL t\u1eeb FDA, EMA v\u00e0 ICH Q5A(R2). S\u1ef1 chuy\u1ec3n \u0111\u1ed5i sang m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y CD v\u00e0 AOF l\u00e0 c\u1ea7n thi\u1ebft \u0111\u1ec3 \u0111\u1ec3 \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u ch\u1ea5t l\u01b0\u1ee3ng cao c\u1ee7a s\u1ea3n ph\u1ea9m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o.\",\"breadcrumb\":{\"@id\":\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#primaryimage\",\"url\":\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/08\/CellCor\u2122-MSC-CD-AOF-ho-tro-chuyen-doi-nuoi-cay-te-bao-avt-1-1.webp\",\"contentUrl\":\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/08\/CellCor\u2122-MSC-CD-AOF-ho-tro-chuyen-doi-nuoi-cay-te-bao-avt-1-1.webp\",\"width\":1600,\"height\":1229},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Biogroup Vietnam | End-to-End Biotechnology Solutions\",\"item\":\"https:\/\/biogroupvietnam.com\/vi\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"News\",\"item\":\"https:\/\/biogroupvietnam.com\/vi\/su-kien-va-tin-tuc\/tin-tuc\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Updates on FBS and HPL usage regulations\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/biogroupvietnam.com\/en\/vi\/#website\",\"url\":\"https:\/\/biogroupvietnam.com\/en\/vi\/\",\"name\":\"Biogroup Vietnam\",\"description\":\"Biogroup Vietnam cung c\u1ea5p d\u1ecbch v\u1ee5 k\u1ef9 thu\u1eadt c\u00f9ng thi\u1ebft b\u1ecb, v\u1eadt t\u01b0, h\u00f3a ch\u1ea5t v\u00e0 gi\u1ea3i ph\u00e1p sinh h\u1ecdc cho ph\u00f2ng th\u00ed nghi\u1ec7m c\u00f4ng ngh\u1ec7 sinh h\u1ecdc, y sinh v\u00e0 y h\u1ecdc t\u00e1i t\u1ea1o.\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/biogroupvietnam.com\/en\/vi\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/biogroupvietnam.com\/vi\/#\/schema\/person\/78a1c640012e6e7bc2bdf0d0fbffea95\",\"name\":\"admin\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/biogroupvietnam.com\/vi\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/biogroupvietnam.com\/wp-content\/litespeed\/avatar\/eb8a826cba57879e3cdbbc4f5ece34eb.jpg?ver=1776157819\",\"contentUrl\":\"https:\/\/biogroupvietnam.com\/wp-content\/litespeed\/avatar\/eb8a826cba57879e3cdbbc4f5ece34eb.jpg?ver=1776157819\",\"caption\":\"admin\"},\"sameAs\":[\"https:\/\/freshfromnature.vn\/\"],\"url\":\"https:\/\/biogroupvietnam.com\/en\/author\/admin\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Updates on FBS and HPL usage regulations","description":"As the field of cell and gene therapy advances, regulatory agencies are tightening the guidelines surrounding the use of fetal bovine serum (FBS) and human platelet lysate (HPL). Agencies such as the FDA and EMA are currently emphasizing the use of materials that are free from animal or human sources. Their focus is on improving&hellip;","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"As the field of cell and gene therapy advances, regulatory agencies are tightening the guidelines surrounding the use of fetal bovine serum (FBS) and human platelet lysate (HPL). Agencies such as the FDA and EMA are currently emphasizing the use of materials that are free from animal or human sources. Their focus is on improving&hellip;","og_locale":"en_US","og_type":"article","og_title":"Updates on FBS and HPL usage regulations","og_description":"As the field of cell and gene therapy advances, regulatory agencies are tightening the guidelines surrounding the use of fetal bovine serum (FBS) and human platelet lysate (HPL). Agencies such as the FDA and EMA are currently emphasizing the use of materials that are free from animal or human sources. Their focus is on improving&hellip;","og_url":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/","og_site_name":"Biogroup Vietnam","article_published_time":"2025-03-10T08:45:00+00:00","article_modified_time":"2025-09-29T07:00:15+00:00","og_image":[{"width":1600,"height":1229,"url":"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/08\/CellCor\u2122-MSC-CD-AOF-ho-tro-chuyen-doi-nuoi-cay-te-bao-avt-1-1.webp","type":"image\/webp"}],"author":"admin","twitter_card":"summary_large_image","twitter_misc":{"Written by":"admin","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#article","isPartOf":{"@id":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/"},"author":{"name":"admin","@id":"https:\/\/biogroupvietnam.com\/vi\/#\/schema\/person\/78a1c640012e6e7bc2bdf0d0fbffea95"},"headline":"Updates on FBS and HPL usage regulations","datePublished":"2025-03-10T08:45:00+00:00","dateModified":"2025-09-29T07:00:15+00:00","mainEntityOfPage":{"@id":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/"},"wordCount":1238,"image":{"@id":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#primaryimage"},"thumbnailUrl":"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/08\/CellCor\u2122-MSC-CD-AOF-ho-tro-chuyen-doi-nuoi-cay-te-bao-avt-1-1.webp","articleSection":["News"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/","url":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/","name":"C\u1eadp nh\u1eadt quy \u0111\u1ecbnh s\u1eed d\u1ee5ng FBS v\u00e0 HPL theo ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf","isPartOf":{"@id":"https:\/\/biogroupvietnam.com\/vi\/#website"},"primaryImageOfPage":{"@id":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#primaryimage"},"image":{"@id":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#primaryimage"},"thumbnailUrl":"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/08\/CellCor\u2122-MSC-CD-AOF-ho-tro-chuyen-doi-nuoi-cay-te-bao-avt-1-1.webp","datePublished":"2025-03-10T08:45:00+00:00","dateModified":"2025-09-29T07:00:15+00:00","author":{"@id":"https:\/\/biogroupvietnam.com\/vi\/#\/schema\/person\/78a1c640012e6e7bc2bdf0d0fbffea95"},"description":"C\u1eadp nh\u1eadt quy \u0111\u1ecbnh s\u1eed d\u1ee5ng FBS v\u00e0 HPL t\u1eeb FDA, EMA v\u00e0 ICH Q5A(R2). S\u1ef1 chuy\u1ec3n \u0111\u1ed5i sang m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y CD v\u00e0 AOF l\u00e0 c\u1ea7n thi\u1ebft \u0111\u1ec3 \u0111\u1ec3 \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u ch\u1ea5t l\u01b0\u1ee3ng cao c\u1ee7a s\u1ea3n ph\u1ea9m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o.","breadcrumb":{"@id":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#primaryimage","url":"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/08\/CellCor\u2122-MSC-CD-AOF-ho-tro-chuyen-doi-nuoi-cay-te-bao-avt-1-1.webp","contentUrl":"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/08\/CellCor\u2122-MSC-CD-AOF-ho-tro-chuyen-doi-nuoi-cay-te-bao-avt-1-1.webp","width":1600,"height":1229},{"@type":"BreadcrumbList","@id":"https:\/\/biogroupvietnam.com\/en\/news\/regulations-on-the-use-of-fbs-hpl\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Biogroup Vietnam | End-to-End Biotechnology Solutions","item":"https:\/\/biogroupvietnam.com\/vi\/"},{"@type":"ListItem","position":2,"name":"News","item":"https:\/\/biogroupvietnam.com\/vi\/su-kien-va-tin-tuc\/tin-tuc\/"},{"@type":"ListItem","position":3,"name":"Updates on FBS and HPL usage regulations"}]},{"@type":"WebSite","@id":"https:\/\/biogroupvietnam.com\/en\/vi\/#website","url":"https:\/\/biogroupvietnam.com\/en\/vi\/","name":"Biogroup Vietnam","description":"Biogroup Vietnam cung c\u1ea5p d\u1ecbch v\u1ee5 k\u1ef9 thu\u1eadt c\u00f9ng thi\u1ebft b\u1ecb, v\u1eadt t\u01b0, h\u00f3a ch\u1ea5t v\u00e0 gi\u1ea3i ph\u00e1p sinh h\u1ecdc cho ph\u00f2ng th\u00ed nghi\u1ec7m c\u00f4ng ngh\u1ec7 sinh h\u1ecdc, y sinh v\u00e0 y h\u1ecdc t\u00e1i t\u1ea1o.","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/biogroupvietnam.com\/en\/vi\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/biogroupvietnam.com\/vi\/#\/schema\/person\/78a1c640012e6e7bc2bdf0d0fbffea95","name":"admin","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/biogroupvietnam.com\/vi\/#\/schema\/person\/image\/","url":"https:\/\/biogroupvietnam.com\/wp-content\/litespeed\/avatar\/eb8a826cba57879e3cdbbc4f5ece34eb.jpg?ver=1776157819","contentUrl":"https:\/\/biogroupvietnam.com\/wp-content\/litespeed\/avatar\/eb8a826cba57879e3cdbbc4f5ece34eb.jpg?ver=1776157819","caption":"admin"},"sameAs":["https:\/\/freshfromnature.vn\/"],"url":"https:\/\/biogroupvietnam.com\/en\/author\/admin\/"}]}},"_links":{"self":[{"href":"https:\/\/biogroupvietnam.com\/en\/wp-json\/wp\/v2\/posts\/4278","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/biogroupvietnam.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/biogroupvietnam.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/biogroupvietnam.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/biogroupvietnam.com\/en\/wp-json\/wp\/v2\/comments?post=4278"}],"version-history":[{"count":9,"href":"https:\/\/biogroupvietnam.com\/en\/wp-json\/wp\/v2\/posts\/4278\/revisions"}],"predecessor-version":[{"id":8062,"href":"https:\/\/biogroupvietnam.com\/en\/wp-json\/wp\/v2\/posts\/4278\/revisions\/8062"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/biogroupvietnam.com\/en\/wp-json\/wp\/v2\/media\/6046"}],"wp:attachment":[{"href":"https:\/\/biogroupvietnam.com\/en\/wp-json\/wp\/v2\/media?parent=4278"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/biogroupvietnam.com\/en\/wp-json\/wp\/v2\/categories?post=4278"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/biogroupvietnam.com\/en\/wp-json\/wp\/v2\/tags?post=4278"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}