{"id":9831,"date":"2026-02-12T11:43:44","date_gmt":"2026-02-12T04:43:44","guid":{"rendered":"https:\/\/biogroupvietnam.com\/dich-vu\/\/"},"modified":"2026-02-12T11:57:10","modified_gmt":"2026-02-12T04:57:10","slug":"vai-tro-moi-truong-cd-aof-gmp","status":"publish","type":"service","link":"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/","title":{"rendered":"S\u1ea3n xu\u1ea5t MSC-EV cho l\u00e2m s\u00e0ng: Vai tr\u00f2 c\u1ee7a m\u00f4i tr\u01b0\u1eddng CD, AOF v\u00e0 GMP"},"content":{"rendered":"\n<p id=\"block-a290e48c-504b-4eda-9bf6-9a2a004d8854\">M\u00f4i tr\u01b0\u1eddng CD, AOF \u0111ang d\u1ea7n tr\u1edf th\u00e0nh ch\u1ee7 \u0111\u1ec1 \u0111\u01b0\u1ee3c quan t\u00e2m h\u00e0ng \u0111\u1ea7u trong s\u1ea3n xu\u1ea5t MSC v\u00e0 MSC-EV, \u0111\u1eb7c bi\u1ec7t khi c\u00e1c y\u00eau c\u1ea7u v\u1ec1 GMP v\u00e0 th\u1ea9m \u0111\u1ecbnh l\u00e2m s\u00e0ng ng\u00e0y c\u00e0ng kh\u1eaft khe. Kh\u00f4ng \u00edt kh\u00e1ch h\u00e0ng \u0111\u1eb7t c\u00e2u h\u1ecfi: m\u00f4i tr\u01b0\u1eddng chemical defined (CD), animal-origin-free (AOF) l\u00e0 g\u00ec, kh\u00e1c g\u00ec so v\u1edbi m\u00f4i tr\u01b0\u1eddng nu\u00f4i MSC truy\u1ec1n th\u1ed1ng c\u00f3 huy\u1ebft thanh, v\u00e0 li\u1ec7u c\u00f3 b\u1eaft bu\u1ed9c ph\u1ea3i s\u1eed d\u1ee5ng m\u00f4i tr\u01b0\u1eddng CD\/AOF trong quy tr\u00ecnh s\u1ea3n xu\u1ea5t MSC-EV hay kh\u00f4ng? Vi\u1ec7c hi\u1ec3u \u0111\u00fang b\u1ea3n ch\u1ea5t v\u00e0 vai tr\u00f2 c\u1ee7a m\u00f4i tr\u01b0\u1eddng CD, AOF ch\u00ednh l\u00e0 b\u01b0\u1edbc \u0111\u1ea7u ti\u00ean \u0111\u1ec3 x\u00e2y d\u1ef1ng quy tr\u00ecnh nu\u00f4i c\u1ea5y \u1ed5n \u0111\u1ecbnh, an to\u00e0n v\u00e0 s\u1eb5n s\u00e0ng cho \u1ee9ng d\u1ee5ng l\u00e2m s\u00e0ng.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/moi-truong-cd-aof-the-he-co-cai-tien-moi-nhat-the-he-thu-3-1024x576.png\" alt=\"M\u00f4i tr\u01b0\u1eddng CD, AOF l\u00e0 th\u1ebf h\u1ec7 c\u00f3 c\u1ea3i ti\u1ebfn m\u1edbi nh\u1ea5t - M\u00f4i tr\u01b0\u1eddng th\u1ebf h\u1ec7 th\u1ee9 3\" class=\"wp-image-9824\" srcset=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/moi-truong-cd-aof-the-he-co-cai-tien-moi-nhat-the-he-thu-3-1024x576.png 1024w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/moi-truong-cd-aof-the-he-co-cai-tien-moi-nhat-the-he-thu-3-300x169.png 300w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/moi-truong-cd-aof-the-he-co-cai-tien-moi-nhat-the-he-thu-3-768x432.png 768w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/moi-truong-cd-aof-the-he-co-cai-tien-moi-nhat-the-he-thu-3-600x338.png 600w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/moi-truong-cd-aof-the-he-co-cai-tien-moi-nhat-the-he-thu-3-90x51.png 90w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/moi-truong-cd-aof-the-he-co-cai-tien-moi-nhat-the-he-thu-3.png 1422w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><figcaption class=\"wp-element-caption\"><em>M\u00f4i tr\u01b0\u1eddng CD, AOF l\u00e0 th\u1ebf h\u1ec7 c\u00f3 c\u1ea3i ti\u1ebfn m\u1edbi nh\u1ea5t &#8211; M\u00f4i tr\u01b0\u1eddng th\u1ebf h\u1ec7 th\u1ee9 3<\/em><\/figcaption><\/figure><\/div>\n\n\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\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Dinh_nghia_moi_truong_CD_AOF\" >\u0110\u1ecbnh ngh\u0129a m\u00f4i tr\u01b0\u1eddng CD, AOF<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Giai_thich_mot_so_nhan_thuong_thay_trong_cac_moi_truong_nuoi_cay_12\" >Gi\u1ea3i th\u00edch m\u1ed9t s\u1ed1 nh\u00e3n th\u01b0\u1eddng th\u1ea5y trong c\u00e1c m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y (1,2)<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Moi_truong_khong_chua_huyet_thanh_Serum-free_media\" >M\u00f4i tr\u01b0\u1eddng kh\u00f4ng ch\u1ee9a huy\u1ebft thanh (Serum-free media)<\/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\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Moi_truong_khong_co_nguon_goc_ngoai_lai_Xeno-free_media\" >M\u00f4i tr\u01b0\u1eddng kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c ngo\u1ea1i lai (Xeno-free media)<\/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\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Moi_truong_khong_chua_protein_Protein-free_media\" >M\u00f4i tr\u01b0\u1eddng kh\u00f4ng ch\u1ee9a protein (Protein-free media)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Moi_truong_co_thanh_phan_hoa_hoc_xac_dinh_chemical_defined_media_%E2%80%93_CD\" >M\u00f4i tr\u01b0\u1eddng c\u00f3 th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc x\u00e1c \u0111\u1ecbnh (chemical defined media \u2013 CD)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Moi_truong_khong_chua_thanh_phan_dong_vat_Animal-component-free_media_%E2%80%93_ACF\" >M\u00f4i tr\u01b0\u1eddng kh\u00f4ng ch\u1ee9a th\u00e0nh ph\u1ea7n \u0111\u1ed9ng v\u1eadt (Animal-component-free media \u2013 ACF)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Moi_truong_khong_co_nguon_goc_tu_dong_vat_Animal-origin-free_media_%E2%80%93_AOF\" >M\u00f4i tr\u01b0\u1eddng kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb \u0111\u1ed9ng v\u1eadt (Animal-origin-free media \u2013 AOF)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Moi_truong_dat_chuan_GMP\" >M\u00f4i tr\u01b0\u1eddng \u0111\u1ea1t chu\u1ea9n GMP<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Su_can_thiet_cua_moi_truong_nuoi_cay_co_thanh_phan_hoa_hoc_xac_dinh_cho_nuoi_cay_quy_mo_cong_nghiep\" >S\u1ef1 c\u1ea7n thi\u1ebft c\u1ee7a m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y c\u00f3 th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc x\u00e1c \u0111\u1ecbnh cho nu\u00f4i c\u1ea5y quy m\u00f4 c\u00f4ng nghi\u1ec7p<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Moi_truong_khong_co_nguon_goc_tu_dong_vat_AOF_Uu_the_va_xu_huong\" >M\u00f4i tr\u01b0\u1eddng kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb \u0111\u1ed9ng v\u1eadt (AOF): \u01afu th\u1ebf v\u00e0 xu h\u01b0\u1edbng<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#GMP_la_tieu_chuan_gi_Khi_nao_thi_can_chuyen_doi_sang_GMP\" >GMP l\u00e0 ti\u00eau chu\u1ea9n g\u00ec? Khi n\u00e0o th\u00ec c\u1ea7n chuy\u1ec3n \u0111\u1ed5i sang GMP?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Dinh_nghia_ve_cGMP\" >\u0110\u1ecbnh ngh\u0129a v\u1ec1 cGMP<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Tai_sao_cGMP_lai_la_tieu_chuan_quan_trong\" >T\u1ea1i sao cGMP l\u1ea1i l\u00e0 ti\u00eau chu\u1ea9n quan tr\u1ecdng<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Khi_nao_thi_can_chuyen_doi_sang_GMP\" >Khi n\u00e0o th\u00ec c\u1ea7n chuy\u1ec3n \u0111\u1ed5i sang GMP<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Moi_truong_GMP_co_y_nghia_gi\" >M\u00f4i tr\u01b0\u1eddng GMP c\u00f3 \u00fd ngh\u0129a g\u00ec<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/biogroupvietnam.com\/en\/service\/vai-tro-moi-truong-cd-aof-gmp\/#Ket_luan\" >K\u1ebft lu\u1eadn<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\" id=\"block-71e615cf-fed2-47a9-8aad-3bef8662341f\"><span class=\"ez-toc-section\" id=\"Dinh_nghia_moi_truong_CD_AOF\"><\/span>\u0110\u1ecbnh ngh\u0129a m\u00f4i tr\u01b0\u1eddng CD, AOF<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p id=\"block-5d0ec4c3-3a81-4067-851e-320e34fe1314\">V\u1ec1 m\u1eb7t \u0111\u1ecbnh ngh\u0129a, m\u00f4i tr\u01b0\u1eddng c\u00f3 th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc x\u00e1c \u0111\u1ecbnh (chemically defined \u2013 CD) l\u00e0 m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y m\u00e0 t\u1ea5t c\u1ea3 c\u00e1c th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc \u0111\u1ec1u \u0111\u01b0\u1ee3c \u0111\u1ecbnh danh v\u00e0 \u0111\u1ecbnh l\u01b0\u1ee3ng ch\u00ednh x\u00e1c. Trong khi \u0111\u00f3, ti\u00eau chu\u1ea9n kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c \u0111\u1ed9ng v\u1eadt (Animal-Origin-Free \u2013 AOF) \u0111\u1ea3m b\u1ea3o quy tr\u00ecnh s\u1ea3n xu\u1ea5t ho\u00e0n to\u00e0n kh\u00f4ng ch\u1ee9a c\u00e1c d\u1eabn xu\u1ea5t t\u1eeb \u0111\u1ed9ng v\u1eadt v\u00e0 ng\u01b0\u1eddi. S\u1ef1 k\u1ebft h\u1ee3p n\u00e0y gi\u1ea3m thi\u1ec3u nguy c\u01a1 nhi\u1ec5m t\u1ea1p ngo\u1ea1i lai v\u00e0 c\u00e1c t\u00e1c nh\u00e2n g\u00e2y b\u1ec7nh c\u00f3 ngu\u1ed3n g\u1ed1c \u0111\u1ed9ng v\u1eadt \u0111\u1ebfn m\u1ee9c th\u1ea5p nh\u1ea5t, \u0111\u1ed3ng th\u1eddi t\u0103ng t\u00ednh \u1ed5n \u0111\u1ecbnh gi\u1eefa c\u00e1c l\u00f4 s\u1ea3n xu\u1ea5t.&nbsp;<\/p>\n\n\n\n<p id=\"block-ec893777-28f2-4099-9bf0-bd9ca3b26e14\">D\u00f9 v\u1ec1 m\u1eb7t hi\u1ec7u su\u1ea5t t\u0103ng tr\u01b0\u1edfng thu\u1ea7n t\u00fay, m\u00f4i tr\u01b0\u1eddng CD\/AOF c\u00f3 th\u1ec3 kh\u00f4ng mang l\u1ea1i s\u1ef1 b\u1ee9t ph\u00e1 v\u01b0\u1ee3t b\u1eadc so v\u1edbi m\u00f4i tr\u01b0\u1eddng c\u00f3 b\u1ed5 sung huy\u1ebft thanh, nh\u01b0ng ch\u00fang l\u1ea1i l\u00e0 \u0111i\u1ec1u ki\u1ec7n c\u1ea7n thi\u1ebft v\u1ec1 m\u1eb7t ph\u00e1p l\u00fd, \u0111\u00e1p \u1ee9ng \u0111\u01b0\u1ee3c c\u00e1c ti\u00eau chu\u1ea9n GMP v\u00e0 v\u01b0\u1ee3t qua c\u00e1c r\u00e0o c\u1ea3n ki\u1ec3m duy\u1ec7t l\u00e2m s\u00e0ng.&nbsp;<\/p>\n\n\n\n<p id=\"block-16782ced-c6a1-4ec3-9e96-079236a9023f\">Nh\u1eb1m gi\u1ea3i quy\u1ebft v\u1ea5n \u0111\u1ec1 tr\u00ean, m\u00f4i tr\u01b0\u1eddng CellCor\u2122 MSC CD AOF \u0111\u1ea1t chu\u1ea9n GMP \u0111\u00e3 ra \u0111\u1eddi, ph\u1ee5c v\u1ee5 t\u0103ng sinh t\u1ebf b\u00e0o. B\u00ean c\u1ea1nh \u0111\u00f3, d\u00f2ng CellCor\u2122 EXO CD, l\u00e0 m\u00f4i tr\u01b0\u1eddng chuy\u00ean d\u1ee5ng \u0111\u1ec3 thu h\u1ed3i t\u00fai ngo\u1ea1i b\u00e0o (EV). V\u1edbi \u01b0u \u0111i\u1ec3m \u0111\u1ed9 tinh khi\u1ebft cao v\u00e0 kh\u00f4ng t\u1ea1p nhi\u1ec5m c\u00e1c h\u1ea1t nh\u1ecf, CellCor\u2122 EXO CD l\u00e0 l\u1ef1a ch\u1ecdn t\u1ed1i \u01b0u cho qu\u00e1 tr\u00ecnh nu\u00f4i c\u1ea5y v\u00e0 t\u00e1ch chi\u1ebft EV h\u1ea1 ngu\u1ed3n.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"block-d4d8febe-d6fd-46dd-a905-6958f9fe11cd\"><span class=\"ez-toc-section\" id=\"Giai_thich_mot_so_nhan_thuong_thay_trong_cac_moi_truong_nuoi_cay_12\"><\/span>Gi\u1ea3i th\u00edch m\u1ed9t s\u1ed1 nh\u00e3n th\u01b0\u1eddng th\u1ea5y trong c\u00e1c m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y (1,2)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"block-4d1a6f2f-30eb-44fb-a24f-14e2c9b05c31\"><span class=\"ez-toc-section\" id=\"Moi_truong_khong_chua_huyet_thanh_Serum-free_media\"><\/span>M\u00f4i tr\u01b0\u1eddng kh\u00f4ng ch\u1ee9a huy\u1ebft thanh (Serum-free media)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p id=\"block-79978736-3f07-43f6-9f05-3ad9d6b41793\">M\u00f4i tr\u01b0\u1eddng ho\u00e0n to\u00e0n lo\u1ea1i b\u1ecf th\u00e0nh ph\u1ea7n huy\u1ebft thanh ho\u1eb7c huy\u1ebft t\u01b0\u01a1ng. So v\u1edbi m\u00f4i tr\u01b0\u1eddng truy\u1ec1n th\u1ed1ng, c\u00e1c d\u00f2ng serum-free media mang l\u1ea1i s\u1ef1 \u1ed5n \u0111\u1ecbnh v\u01b0\u1ee3t tr\u1ed9i gi\u1eefa c\u00e1c l\u00f4 s\u1ea3n xu\u1ea5t (batch-to-batch consistency), \u0111\u1ed3ng th\u1eddi cho ph\u00e9p ng\u01b0\u1eddi d\u00f9ng ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd h\u01a1n c\u00e1c \u0111i\u1ec1u ki\u1ec7n nu\u00f4i c\u1ea5y&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"block-783107a4-bf2d-4764-8228-a5785c451933\"><span class=\"ez-toc-section\" id=\"Moi_truong_khong_co_nguon_goc_ngoai_lai_Xeno-free_media\"><\/span>M\u00f4i tr\u01b0\u1eddng kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c ngo\u1ea1i lai (Xeno-free media)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p id=\"block-1584cff5-e422-489c-9c8d-5b1d22eee7ef\">M\u00f4i tr\u01b0\u1eddng kh\u00f4ng ch\u1ee9a c\u00e1c th\u00e0nh ph\u1ea7n c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb \u0111\u1ed9ng v\u1eadt kh\u00f4ng ph\u1ea3i ng\u01b0\u1eddi. Tuy nhi\u00ean, m\u00f4i tr\u01b0\u1eddng n\u00e0y c\u00f3 kh\u1ea3 n\u0103ng ch\u1ee9a c\u00e1c th\u00e0nh ph\u1ea7n t\u1eeb ng\u01b0\u1eddi nh\u01b0 huy\u1ebft thanh ng\u01b0\u1eddi (human serum), holo-transferrin, ho\u1eb7c insulin.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"block-cc6336f3-5d63-465c-92ae-ffcf37bfdeeb\"><span class=\"ez-toc-section\" id=\"Moi_truong_khong_chua_protein_Protein-free_media\"><\/span>M\u00f4i tr\u01b0\u1eddng kh\u00f4ng ch\u1ee9a protein (Protein-free media)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p id=\"block-f97d003a-eab2-4a0f-9e02-8f7eb437efb3\">M\u00f4i tr\u01b0\u1eddng kh\u00f4ng ch\u1ee9a protein ho\u1eb7c polypeptides trong th\u00e0nh ph\u1ea7n c\u00f4ng th\u1ee9c. M\u00f4i tr\u01b0\u1eddng n\u00e0y c\u00f3 th\u1ec3 ch\u1ee9a amino acids t\u1ef1 do, dipeptides ho\u1eb7c tripeptides chi\u1ebft xu\u1ea5t t\u1eeb ngu\u1ed3n kh\u00f4ng ph\u1ea3i \u0111\u1ed9ng v\u1eadt. C\u00f3 th\u1ec3 ch\u1ee9a d\u1ecbch th\u1ee7y ph\u00e2n t\u1eeb th\u1ef1c v\u1eadt, n\u1ea5m men ho\u1eb7c vi khu\u1ea9n.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"block-311d1f02-9f02-4e78-8f78-e26e79e37759\"><span class=\"ez-toc-section\" id=\"Moi_truong_co_thanh_phan_hoa_hoc_xac_dinh_chemical_defined_media_%E2%80%93_CD\"><\/span>M\u00f4i tr\u01b0\u1eddng c\u00f3 th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc x\u00e1c \u0111\u1ecbnh (chemical defined media \u2013 CD)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p id=\"block-45c7580c-c71f-4934-a5de-c9838e7251d6\">Lo\u1ea1i m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o ch\u1ee9a c\u00e1c th\u00e0nh ph\u1ea7n h\u1eefu c\u01a1 v\u00e0 v\u00f4 c\u01a1 tinh khi\u1ebft, c\u00f9ng c\u00e1c protein, vitamin, axit b\u00e9o v\u00e0 c\u00e1c y\u1ebfu t\u1ed1 t\u0103ng tr\u01b0\u1edfng \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u1ecbnh l\u01b0\u1ee3ng r\u00f5 r\u00e0ng.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"block-80aa6918-8dc0-4d3d-8721-34de6bd53a21\"><span class=\"ez-toc-section\" id=\"Moi_truong_khong_chua_thanh_phan_dong_vat_Animal-component-free_media_%E2%80%93_ACF\"><\/span>M\u00f4i tr\u01b0\u1eddng kh\u00f4ng ch\u1ee9a th\u00e0nh ph\u1ea7n \u0111\u1ed9ng v\u1eadt (Animal-component-free media \u2013 ACF)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p id=\"block-da367ef6-0c8f-4c9b-892d-20e1ee8a273d\">M\u00f4i tr\u01b0\u1eddng kh\u00f4ng ch\u1ee9a ho\u1eb7c kh\u00f4ng s\u1eed d\u1ee5ng b\u1ea5t k\u1ef3 nguy\u00ean li\u1ec7u th\u00f4 s\u01a1 c\u1ea5p n\u00e0o c\u00f3 ngu\u1ed3n g\u1ed1c tr\u1ef1c ti\u1ebfp t\u1eeb m\u00f4 ho\u1eb7c d\u1ecbch c\u01a1 th\u1ec3 \u0111\u1ed9ng v\u1eadt (bao g\u1ed3m c\u1ea3 ng\u01b0\u1eddi) trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t. M\u00f4i tr\u01b0\u1eddng c\u00f3 th\u1ec3 ch\u1ee9a c\u00e1c protein \u0111\u1ed9ng v\u1eadt t\u00e1i t\u1ed5 h\u1ee3p, bao g\u1ed3m c\u1ea3 nh\u1eefng lo\u1ea1i \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t t\u1eeb c\u00e1c d\u00f2ng t\u1ebf b\u00e0o \u0111\u1ed9ng v\u1eadt ho\u1eb7c th\u00f4ng qua qu\u00e1 tr\u00ecnh l\u00ean men.&nbsp;<\/p>\n\n\n\n<p id=\"block-8eba1777-7f31-4be8-9bad-a453c1a019f3\"><strong>V\u00ed d\u1ee5:<\/strong> m\u00f4i tr\u01b0\u1eddng c\u00f3 ch\u1ee9a protein ng\u01b0\u1eddi t\u00e1i t\u1ed5 h\u1ee3p \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t t\u1eeb t\u1ebf b\u00e0o th\u1eadn ph\u00f4i ng\u01b0\u1eddi (HEK).&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"block-41d6987e-bc99-4a79-8272-7818c9f8ec79\"><span class=\"ez-toc-section\" id=\"Moi_truong_khong_co_nguon_goc_tu_dong_vat_Animal-origin-free_media_%E2%80%93_AOF\"><\/span>M\u00f4i tr\u01b0\u1eddng kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb \u0111\u1ed9ng v\u1eadt (Animal-origin-free media \u2013 AOF)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p id=\"block-02729146-04b9-4b45-b116-ff9602eece00\">S\u1ea3n ph\u1ea9m cu\u1ed1i c\u00f9ng kh\u00f4ng ch\u1ee9a v\u00e0 kh\u00f4ng s\u1eed d\u1ee5ng b\u1ea5t k\u1ef3 nguy\u00ean li\u1ec7u th\u00f4 s\u01a1 c\u1ea5p hay th\u1ee9 c\u1ea5p n\u00e0o c\u00f3 ngu\u1ed3n g\u1ed1c tr\u1ef1c ti\u1ebfp t\u1eeb m\u00f4 ho\u1eb7c d\u1ecbch c\u01a1 th\u1ec3 \u0111\u1ed9ng v\u1eadt (bao g\u1ed3m c\u1ea3 ng\u01b0\u1eddi) trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t. C\u00e1c nguy\u00ean li\u1ec7u th\u00f4 tam c\u1ea5p c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c d\u1eabn xu\u1ea5t t\u1eeb m\u00f4, d\u1ecbch c\u01a1 th\u1ec3 ho\u1eb7c c\u00e1c d\u00f2ng t\u1ebf b\u00e0o \u0111\u1ed9ng v\u1eadt (bao g\u1ed3m c\u1ea3 ng\u01b0\u1eddi).&nbsp;<\/p>\n\n\n\n<p id=\"block-1f943668-e2ad-4738-91f7-6d471c03e731\"><strong>V\u00ed d\u1ee5:<\/strong> m\u00f4i tr\u01b0\u1eddng ch\u1ee9a protein ng\u01b0\u1eddi t\u00e1i t\u1ed5 h\u1ee3p \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t v\u00e0 chi\u1ebft xu\u1ea5t t\u1eeb g\u1ea1o.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"block-66a0c264-006b-423d-9172-f87390e8cb72\"><span class=\"ez-toc-section\" id=\"Moi_truong_dat_chuan_GMP\"><\/span>M\u00f4i tr\u01b0\u1eddng \u0111\u1ea1t chu\u1ea9n GMP<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p id=\"block-b9898f52-6332-41f9-8c49-ce30756b5438\">L\u00e0 m\u00f4i tr\u01b0\u1eddng \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t d\u1ef1a tr\u00ean quy tr\u00ecnh m\u00e0 t\u1ea5t c\u1ea3 s\u1ea3n ph\u1ea9m, nguy\u00ean li\u1ec7u, thi\u1ebft b\u1ecb v\u00e0 c\u00f4ng \u0111o\u1ea1n v\u1eadn h\u00e0nh \u0111\u1ec1u c\u00f3 kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c v\u00e0 \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"block-c27f77d7-12e5-43d9-ba6f-79074686b597\"><span class=\"ez-toc-section\" id=\"Su_can_thiet_cua_moi_truong_nuoi_cay_co_thanh_phan_hoa_hoc_xac_dinh_cho_nuoi_cay_quy_mo_cong_nghiep\"><\/span>S\u1ef1 c\u1ea7n thi\u1ebft c\u1ee7a m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y c\u00f3 th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc x\u00e1c \u0111\u1ecbnh cho nu\u00f4i c\u1ea5y quy m\u00f4 c\u00f4ng nghi\u1ec7p<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p id=\"block-71ca7765-0bc3-4ace-810a-fd3d87a25b52\">Trong s\u1ea3n xu\u1ea5t c\u00f4ng nghi\u1ec7p, t\u00ednh \u1ed5n \u0111\u1ecbnh c\u1ee7a t\u1eebng m\u1ebb nu\u00f4i c\u1ea5y l\u00e0 ti\u00eau ch\u00ed c\u1ed1t l\u00f5i \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 s\u1ef1 \u0111\u1ed3ng nh\u1ea5t c\u1ee7a s\u1ea3n ph\u1ea9m \u0111\u1ea7u ra. Vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c th\u00e0nh ph\u1ea7n kh\u00f4ng x\u00e1c \u0111\u1ecbnh trong m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y lu\u00f4n ti\u1ec1m \u1ea9n r\u1ee7i ro l\u00e0m s\u1ee5t gi\u1ea3m s\u1ea3n l\u01b0\u1ee3ng v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng b\u1ea5t th\u01b0\u1eddng (3). \u0110i\u1ec1u n\u00e0y kh\u00f4ng ch\u1ec9 g\u00e2y l\u00e3ng ph\u00ed ngu\u1ed3n l\u1ef1c m\u00e0 c\u00f2n g\u00e2y kh\u00f3 kh\u0103n l\u1edbn cho qu\u00e1 tr\u00ecnh \u0111i\u1ec1u tra v\u00e0 kh\u1eafc ph\u1ee5c s\u1ef1 c\u1ed1 c\u0169ng nh\u01b0 t\u1ed1i \u01b0u h\u00f3a quy tr\u00ecnh.<\/p>\n\n\n\n<p id=\"block-9383db0f-590d-45bf-8f3c-5a0a96c2d7c8\">M\u1ed9t minh ch\u1ee9ng kh\u00e1c n\u1eb1m \u1edf vi\u1ec7c s\u1eed d\u1ee5ng huy\u1ebft thanh thai b\u00f2 (FBS). Ngay c\u1ea3 khi \u0111\u1ebfn t\u1eeb c\u00f9ng m\u1ed9t nh\u00e0 s\u1ea3n xu\u1ea5t, c\u00e1c l\u00f4 FBS kh\u00e1c nhau v\u1eabn c\u00f3 s\u1ef1 bi\u1ebfn thi\u00ean l\u1edbn v\u1ec1 th\u00e0nh ph\u1ea7n, g\u00e2y \u1ea3nh h\u01b0\u1edfng tr\u1ef1c ti\u1ebfp \u0111\u1ebfn kh\u1ea3 n\u0103ng t\u0103ng sinh c\u1ee7a t\u1ebf b\u00e0o. Nghi\u00ean c\u1ee9u c\u1ee7a Zhang v\u00e0 c\u1ed9ng s\u1ef1 tr\u00ean d\u00f2ng t\u1ebf b\u00e0o bi\u1ec3u m\u00f4 s\u1eafc t\u1ed1 v\u00f5ng m\u1ea1c ng\u01b0\u1eddi tr\u01b0\u1edfng th\u00e0nh (ARPE) \u0111\u00e3 ch\u1ec9 ra r\u1eb1ng: ba l\u00f4 FBS kh\u00e1c nhau t\u1eeb hai nh\u00e0 cung c\u1ea5p cho t\u1ed1c \u0111\u1ed9 ph\u00e1t tri\u1ec3n t\u1ebf b\u00e0o ho\u00e0n to\u00e0n kh\u00e1c bi\u1ec7t (4). M\u1eb7c d\u00f9 h\u00e0m l\u01b0\u1ee3ng protein ch\u00ednh t\u01b0\u01a1ng \u0111\u01b0\u01a1ng nhau, nh\u01b0ng l\u00f4 FBS cho t\u1ed1c \u0111\u1ed9 t\u0103ng sinh nhanh nh\u1ea5t l\u1ea1i ch\u1ee9a c\u00e1c y\u1ebfu t\u1ed1 t\u0103ng tr\u01b0\u1edfng v\u00e0 protein li\u00ean k\u1ebft \u0111\u1eb7c hi\u1ec7u m\u00e0 c\u00e1c l\u00f4 c\u00f2n l\u1ea1i kh\u00f4ng c\u00f3 (4). S\u1ef1 kh\u00e1c bi\u1ec7t kh\u00f3 ki\u1ec3m so\u00e1t n\u00e0y ch\u00ednh l\u00e0 r\u00e0o c\u1ea3n l\u1edbn nh\u1ea5t trong vi\u1ec7c chu\u1ea9n h\u00f3a c\u00e1c quy tr\u00ecnh nu\u00f4i c\u1ea5y hi\u1ec7n nay.&nbsp;<\/p>\n\n\n\n<p id=\"block-b82e6d49-0de6-4eae-a5e4-06de6a2ad5b2\">Hi\u1ec7n nay, nhi\u1ec1u nghi\u00ean c\u1ee9u MSC v\u1eabn \u0111ang s\u1eed d\u1ee5ng m\u00f4i tr\u01b0\u1eddng truy\u1ec1n th\u1ed1ng l\u00e0 DMEM b\u1ed5 sung 10% serum (t\u1eeb b\u00f2 ho\u1eb7c t\u1eeb ng\u01b0\u1eddi). H\u1ec7 th\u1ed1ng n\u00e0y c\u00f3 th\u1ec3 ph\u00f9 h\u1ee3p \u1edf quy m\u00f4 ph\u00f2ng th\u00ed nghi\u1ec7m ho\u1eb7c khi m\u1edbi thi\u1ebft l\u1eadp quy tr\u00ecnh ban \u0111\u1ea7u, nh\u01b0ng s\u1ebd b\u1ed9c l\u1ed9 nhi\u1ec1u h\u1ea1n ch\u1ebf n\u1ebfu mu\u1ed1n t\u0103ng quy m\u00f4 s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd \u0111\u1ea7u v\u00e0o&nbsp;<\/p>\n\n\n\n<p id=\"block-68b4fa12-7822-4216-959d-2af7190bcd4a\">Th\u1ef1c t\u1ebf, \u0111\u00e3 c\u00f3 nh\u00f3m nghi\u00ean c\u1ee9u chuy\u1ec3n sang d\u00f9ng hPL (d\u1ecbch ly gi\u1ea3i ti\u1ec3u c\u1ea7u ng\u01b0\u1eddi) \u0111\u1ec3 thay th\u1ebf FBS. Tuy nhi\u00ean, khi b\u1eaft \u0111\u1ea7u n\u00e2ng quy m\u00f4, h\u1ecd \u0111\u00e3 g\u1eb7p ph\u1ea3i m\u1ed9t \u0111i\u1ec3m ngh\u1ebdn l\u1edbn l\u00e0 t\u1ebf b\u00e0o kh\u00f4ng t\u0103ng sinh nhanh nh\u01b0 d\u1ef1 \u0111o\u00e1n. Sau khi \u0111i\u1ec1u tra, nh\u00f3m m\u1edbi ph\u00e1t hi\u1ec7n l\u00f4 hPL m\u1edbi \u0111\u00e3 b\u1ecb nhi\u1ec5m mycoplasma. S\u1ef1 c\u1ed1 n\u00e0y kh\u00f4ng ch\u1ec9 g\u00e2y gi\u00e1n \u0111o\u1ea1n m\u00e0 c\u00f2n khi\u1ebfn h\u1ecd m\u1ea5t t\u1edbi v\u00e0i th\u00e1ng \u0111\u1ec3 kh\u1eafc ph\u1ee5c v\u00e0 l\u00e0m s\u1ea1ch h\u1ec7 th\u1ed1ng.&nbsp;<\/p>\n\n\n\n<p id=\"block-8f8afe5b-c23c-4ee8-a278-3696d7ce06de\">Do \u0111\u00f3, vi\u1ec7c chuy\u1ec3n d\u1ecbch sang m\u00f4i tr\u01b0\u1eddng Chemically Defined (CD) ch\u00ednh l\u00e0 gi\u1ea3i ph\u00e1p \u0111\u1ec3 tr\u00e1nh nh\u1eefng r\u1ee7i ro b\u1ea5t ng\u1edd nh\u01b0 tr\u00ean. M\u00f4i tr\u01b0\u1eddng CD \u0111\u1ea3m b\u1ea3o s\u1ef1 \u1ed5n \u0111\u1ecbnh tuy\u1ec7t \u0111\u1ed1i gi\u1eefa c\u00e1c m\u1ebb nu\u00f4i c\u1ea5y, gi\u00fap nh\u00e0 nghi\u00ean c\u1ee9u ho\u00e0n to\u00e0n ki\u1ec3m so\u00e1t \u0111\u01b0\u1ee3c quy tr\u00ecnh, t\u1eeb \u0111\u00f3 \u0111\u01a1n gi\u1ea3n h\u00f3a vi\u1ec7c theo d\u00f5i v\u00e0 t\u1ed1i \u01b0u h\u00f3a s\u1ea3n xu\u1ea5t \u1edf quy m\u00f4 l\u1edbn.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"block-52164fe5-5298-4844-a0e7-605c17d64c70\"><span class=\"ez-toc-section\" id=\"Moi_truong_khong_co_nguon_goc_tu_dong_vat_AOF_Uu_the_va_xu_huong\"><\/span>M\u00f4i tr\u01b0\u1eddng kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb \u0111\u1ed9ng v\u1eadt (AOF): \u01afu th\u1ebf v\u00e0 xu h\u01b0\u1edbng<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p id=\"block-8ccbbb62-b73b-4b14-bdf6-4fe68879f9c9\">Ng\u00e0nh c\u00f4ng nghi\u1ec7p sinh h\u1ecdc \u0111\u00e3 tr\u1ea3i qua nhi\u1ec1u b\u00e0i h\u1ecdc \u0111\u1eaft gi\u00e1: t\u1eeb th\u1ea3m h\u1ecda nhi\u1ec5m mycoplasma (th\u1eadp ni\u00ean 70), n\u1ed7i lo v\u1ec1 endotoxin (th\u1eadp ni\u00ean 80) cho \u0111\u1ebfn cu\u1ed9c kh\u1ee7ng ho\u1ea3ng b\u00f2 \u0111i\u00ean BSE (th\u1eadp ni\u00ean 90). Ch\u00ednh nh\u1eefng c\u1ed9t m\u1ed1c n\u00e0y \u0111\u00e3 h\u00ecnh th\u00e0nh n\u00ean ti\u00eau chu\u1ea9n kh\u1eaft khe v\u1ec1 vi\u1ec7c truy xu\u1ea5t ngu\u1ed3n g\u1ed1c nguy\u00ean li\u1ec7u ng\u00e0y nay.&nbsp;<\/p>\n\n\n\n<p id=\"block-65edb112-911a-4616-9a2e-1b12924a2080\">\u0110\u1ec3 ng\u0103n ng\u1eeba nh\u1eefng r\u1ee7i ro t\u01b0\u01a1ng t\u1ef1 tr\u00ean di\u1ec7n r\u1ed9ng, FDA v\u00e0 ICH \u0111\u00e3 \u0111\u01b0a ra c\u00e1c h\u01b0\u1edbng d\u1eabn nghi\u00eam ng\u1eb7t nh\u1eb1m ki\u1ec3m so\u00e1t t\u00ednh an to\u00e0n c\u1ee7a sinh ph\u1ea9m v\u00e0 ho\u1ea1t ch\u1ea5t. C\u1ee5 th\u1ec3, theo h\u01b0\u1edbng d\u1eabn ICH Q5A(R2) v\u1ec1 \u0111\u00e1nh gi\u00e1 an to\u00e0n virus cho c\u00e1c s\u1ea3n ph\u1ea9m sinh h\u1ecdc, c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u01b0\u1ee3c khuy\u1ebfn c\u00e1o (5):&nbsp;<\/p>\n\n\n\n<p id=\"block-5329dd06-9167-4fcd-b0fe-39bb1b5e8ee9\"><strong>\u01afu ti\u00ean thay th\u1ebf:<\/strong> C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t n\u00ean tr\u00e1nh s\u1eed d\u1ee5ng nguy\u00ean li\u1ec7u ngu\u1ed3n g\u1ed1c t\u1eeb ng\u01b0\u1eddi v\u00e0 \u0111\u1ed9ng v\u1eadt (nh\u01b0 huy\u1ebft thanh, trypsin&#8230;) trong quy tr\u00ecnh s\u1ea3n xu\u1ea5t b\u1ea5t c\u1ee9 khi n\u00e0o c\u00f3 th\u1ec3.&nbsp;<\/p>\n\n\n\n<p id=\"block-d4476cda-7c70-42c7-bdde-79346a66bcd8\"><strong>Minh b\u1ea1ch h\u1ed3 s\u01a1:<\/strong> N\u1ebfu b\u1eaft bu\u1ed9c ph\u1ea3i s\u1eed d\u1ee5ng, nh\u00e0 s\u1ea3n xu\u1ea5t ph\u1ea3i cung c\u1ea5p \u0111\u1ea7y \u0111\u1ee7 d\u1eef li\u1ec7u v\u1ec1 qu\u1ed1c gia xu\u1ea5t x\u1ee9, lo\u1ea1i m\u00f4 ngu\u1ed3n g\u1ed1c, c\u00e1c b\u01b0\u1edbc b\u1ea5t ho\u1ea1t virus ho\u1eb7c quy tr\u00ecnh lo\u1ea1i b\u1ecf virus \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t nguy\u00ean li\u1ec7u, c\u0169ng nh\u01b0 c\u00e1c lo\u1ea1i x\u00e9t nghi\u1ec7m virus \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n tr\u00ean nguy\u00ean li\u1ec7u th\u00f4 \u0111\u00f3 \u0111\u1ec1u ph\u1ea3i \u0111\u01b0\u1ee3c cung c\u1ea5p \u0111\u1ea7y \u0111\u1ee7. C\u00e1c x\u00e9t nghi\u1ec7m n\u00e0y n\u00ean \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n tr\u01b0\u1edbc giai \u0111o\u1ea1n b\u1ea5t ho\u1ea1t.&nbsp;<\/p>\n\n\n\n<p id=\"block-be409379-dd1f-4e91-869c-4ef47b71cffd\"><strong>Ki\u1ec3m so\u00e1t b\u1ed5 sung:<\/strong> Trong tr\u01b0\u1eddng h\u1ee3p c\u00f3 nguy c\u01a1 cao, c\u00e1c nguy\u00ean li\u1ec7u nh\u01b0 huy\u1ebft thanh ho\u1eb7c trypsin ph\u1ea3i \u0111\u01b0\u1ee3c x\u1eed l\u00fd b\u1ea5t ho\u1ea1t virus (nh\u01b0 chi\u1ebfu x\u1ea1 ion h\u00f3a). Ngo\u00e0i ra, nh\u00e0 s\u1ea3n xu\u1ea5t c\u1ea7n \u00e1p d\u1ee5ng th\u00eam c\u00e1c chi\u1ebfn l\u01b0\u1ee3c gi\u1ea3m thi\u1ec3u r\u1ee7i ro nh\u01b0 l\u1ecdc virus, x\u1eed l\u00fd nhi\u1ec7t cao trong th\u1eddi gian ng\u1eafn ho\u1eb7c chi\u1ebfu x\u1ea1 UVC \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o an to\u00e0n tuy\u1ec7t \u0111\u1ed1i.&nbsp;<\/p>\n\n\n\n<p id=\"block-8a05c4a6-c7f9-4fe1-b6e5-c8871ff29dc9\">Vi\u1ec7c s\u1eed d\u1ee5ng m\u00f4i tr\u01b0\u1eddng ch\u1ee9a th\u00e0nh ph\u1ea7n t\u1eeb \u0111\u1ed9ng v\u1eadt ho\u1eb7c ng\u01b0\u1eddi th\u01b0\u1eddng d\u1eabn \u0111\u1ebfn g\u00e1nh n\u1eb7ng v\u1ec1 th\u1ee7 t\u1ee5c h\u00e0nh ch\u00ednh khi l\u1eadp h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd s\u1ea3n ph\u1ea9m. Do \u0111\u00f3, m\u00f4i tr\u01b0\u1eddng kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c \u0111\u1ed9ng v\u1eadt (AOF) \u0111ang tr\u1edf th\u00e0nh l\u1ef1a ch\u1ecdn \u01b0u ti\u00ean c\u1ee7a c\u00e1c \u0111\u01a1n v\u1ecb s\u1ea3n xu\u1ea5t nh\u1edd nh\u1eefng l\u1ee3i th\u1ebf v\u01b0\u1ee3t tr\u1ed9i:&nbsp;<\/p>\n\n\n\n<p id=\"block-88c68c26-a31d-456c-97bd-cae6e82ecfb9\"><strong>Ki\u1ec3m so\u00e1t an to\u00e0n: <\/strong>Lo\u1ea1i b\u1ecf c\u00e1c r\u1ee7i ro sinh h\u1ecdc kh\u00f3 l\u01b0\u1eddng v\u00e0 nguy c\u01a1 nhi\u1ec5m t\u1ea1p virus.&nbsp;<\/p>\n\n\n\n<p id=\"block-34e1e8c9-ca5a-458a-809f-7955f60ae963\"><strong>T\u1ed1i gi\u1ea3n h\u1ed3 s\u01a1:<\/strong> Gi\u1ea3m \u00e1p l\u1ef1c v\u1ec1 vi\u1ec7c ch\u1ee9ng minh ngu\u1ed3n g\u1ed1c v\u00e0 ki\u1ec3m so\u00e1t virus tr\u01b0\u1edbc c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd (FDA\/ICH).&nbsp;<\/p>\n\n\n\n<p id=\"block-8a74b73b-dd6a-42a5-b949-f237c7bbe9df\"><strong>Ti\u00eau chu\u1ea9n h\u00f3a: <\/strong>\u0110\u00e1p \u1ee9ng ho\u00e0n h\u1ea3o c\u00e1c y\u00eau c\u1ea7u kh\u1eaft khe trong qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng d\u01b0\u1ee3c ph\u1ea9m hi\u1ec7n nay.&nbsp;<\/p>\n\n\n\n<p id=\"block-73deb92e-5b1f-4be7-8cbe-e1d96e6b2323\">D\u00f9 nhi\u1ec1u quy tr\u00ecnh ban \u0111\u1ea7u v\u1eabn s\u1eed d\u1ee5ng m\u00f4i tr\u01b0\u1eddng ch\u1ee9a th\u00e0nh ph\u1ea7n t\u1eeb \u0111\u1ed9ng v\u1eadt \u1edf giai \u0111o\u1ea1n nghi\u00ean c\u1ee9u, vi\u1ec7c thi\u1ebft l\u1eadp l\u1ed9 tr\u00ecnh chuy\u1ec3n \u0111\u1ed5i sang AOF n\u00ean \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n ngay t\u1eeb s\u1edbm. \u0110i\u1ec1u n\u00e0y gi\u00fap doanh nghi\u1ec7p tr\u00e1nh \u0111\u01b0\u1ee3c vi\u1ec7c ph\u1ea3i t\u00e1i thi\u1ebft k\u1ebf quy tr\u00ecnh t\u1ed1n k\u00e9m v\u00e0 m\u1ea5t th\u1eddi gian khi b\u01b0\u1edbc v\u00e0o giai \u0111o\u1ea1n s\u1ea3n xu\u1ea5t l\u00e2m s\u00e0ng.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"block-8124839c-2332-4a35-8be7-3247d308f0af\"><span class=\"ez-toc-section\" id=\"GMP_la_tieu_chuan_gi_Khi_nao_thi_can_chuyen_doi_sang_GMP\"><\/span>GMP l\u00e0 ti\u00eau chu\u1ea9n g\u00ec? Khi n\u00e0o th\u00ec c\u1ea7n chuy\u1ec3n \u0111\u1ed5i sang GMP?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"block-5f0d8b24-39e8-4999-bc1b-5a598defe833\"><span class=\"ez-toc-section\" id=\"Dinh_nghia_ve_cGMP\"><\/span>\u0110\u1ecbnh ngh\u0129a v\u1ec1 cGMP<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p id=\"block-a209d4e5-6b9d-45c8-ba97-5e2816e5e1f6\">CGMP l\u00e0 c\u00e1c quy \u0111\u1ecbnh v\u1ec1 Th\u1ef1c h\u00e0nh t\u1ed1t s\u1ea3n xu\u1ea5t hi\u1ec7n h\u00e0nh (current good manufacturing practice) do FDA gi\u00e1m s\u00e1t v\u00e0 th\u1ef1c thi. CGMP cung c\u1ea5p m\u1ed9t h\u1ec7 th\u1ed1ng nh\u1eb1m \u0111\u1ea3m b\u1ea3o vi\u1ec7c thi\u1ebft k\u1ebf, gi\u00e1m s\u00e1t v\u00e0 ki\u1ec3m so\u00e1t quy tr\u00ecnh s\u1ea3n xu\u1ea5t c\u0169ng nh\u01b0 c\u01a1 s\u1edf h\u1ea1 t\u1ea7ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n m\u1ed9t c\u00e1ch ph\u00f9 h\u1ee3p. Vi\u1ec7c tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh cGMP gi\u00fap b\u1ea3o \u0111\u1ea3m danh t\u00ednh, ho\u1ea1t l\u1ef1c, ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 \u0111\u1ed9 tinh khi\u1ebft c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c, th\u00f4ng qua y\u00eau c\u1ea7u c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m ph\u1ea3i ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd m\u1ecdi ho\u1ea1t \u0111\u1ed9ng v\u1eadn h\u00e0nh s\u1ea3n xu\u1ea5t (10).<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" width=\"686\" height=\"692\" src=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/5-Ps-of-GMP.png\" alt=\"\" class=\"wp-image-9825\" srcset=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/5-Ps-of-GMP.png 686w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/5-Ps-of-GMP-297x300.png 297w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/5-Ps-of-GMP-150x150.png 150w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/5-Ps-of-GMP-600x605.png 600w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/02\/5-Ps-of-GMP-54x54.png 54w\" sizes=\"(max-width: 686px) 100vw, 686px\" \/><figcaption class=\"wp-element-caption\"><em>5 Ps of Good Manufacturing Practice (GMP) (Ngu\u1ed3n: FoodDocs \u2013 fooddocs.com)<\/em><\/figcaption><\/figure><\/div>\n\n\n<h3 class=\"wp-block-heading\" id=\"block-018d1508-86d9-4cad-9061-5feaf5d44af6\"><span class=\"ez-toc-section\" id=\"Tai_sao_cGMP_lai_la_tieu_chuan_quan_trong\"><\/span>T\u1ea1i sao cGMP l\u1ea1i l\u00e0 ti\u00eau chu\u1ea9n quan tr\u1ecdng<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p id=\"block-bdc261e9-6a62-4be5-92cf-fb9a188ae861\">Th\u1ef1c t\u1ebf, ng\u01b0\u1eddi ti\u00eau d\u00f9ng kh\u00f4ng th\u1ec3 nh\u1eadn bi\u1ebft m\u1ed9t s\u1ea3n ph\u1ea9m thu\u1ed1c c\u00f3 an to\u00e0n hay hi\u1ec7u qu\u1ea3 hay kh\u00f4ng ch\u1ec9 b\u1eb1ng c\u1ea3m quan th\u00f4ng th\u01b0\u1eddng. D\u00f9 vi\u1ec7c ki\u1ec3m nghi\u1ec7m s\u1ea3n ph\u1ea9m l\u00e0 b\u1eaft bu\u1ed9c, nh\u01b0ng ch\u1ec9 ri\u00eang kh\u00e2u n\u00e0y l\u00e0 kh\u00f4ng \u0111\u1ee7 \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng. Th\u00f4ng th\u01b0\u1eddng, vi\u1ec7c ki\u1ec3m so\u00e1t ch\u1ec9 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n tr\u00ean m\u1ed9t m\u1eabu nh\u1ecf (v\u00ed d\u1ee5: test 100 vi\u00ean trong l\u00f4 2 tri\u1ec7u vi\u00ean), nh\u1eb1m gi\u1eef l\u1ea1i ph\u1ea7n l\u1edbn s\u1ea3n ph\u1ea9m ph\u1ee5c v\u1ee5 b\u1ec7nh nh\u00e2n thay v\u00ec ti\u00eau h\u1ee7y h\u1ebft cho vi\u1ec7c th\u1eed nghi\u1ec7m. Do \u0111\u00f3, \u0111i\u1ec1u c\u1ed1t y\u1ebfu l\u00e0 thu\u1ed1c ph\u1ea3i \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t trong c\u00e1c \u0111i\u1ec1u ki\u1ec7n v\u00e0 quy tr\u00ecnh nghi\u00eam ng\u1eb7t theo quy \u0111\u1ecbnh CGMP, nh\u1eb1m \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng \u0111\u01b0\u1ee3c t\u00edch h\u1ee3p v\u00e0o t\u1eebng b\u01b0\u1edbc c\u1ee7a quy tr\u00ecnh thi\u1ebft k\u1ebf v\u00e0 s\u1ea3n xu\u1ea5t (10).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"block-9e01663e-721a-432d-bd84-127db5f06619\"><span class=\"ez-toc-section\" id=\"Khi_nao_thi_can_chuyen_doi_sang_GMP\"><\/span>Khi n\u00e0o th\u00ec c\u1ea7n chuy\u1ec3n \u0111\u1ed5i sang GMP<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p id=\"block-52b3f8ce-802c-495f-83aa-16bd9d74c4be\">Theo quy \u0111\u1ecbnh t\u1eeb FDA v\u00e0 EMA, c\u00e1c s\u1ea3n ph\u1ea9m l\u00e0 thu\u1ed1c ho\u1eb7c li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o \u0111\u1ec1u b\u1eaft bu\u1ed9c ph\u1ea3i \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n GMP tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p s\u1eed d\u1ee5ng tr\u00ean ng\u01b0\u1eddi (6\u20138). Ngay c\u1ea3 \u0111\u1ed1i v\u1edbi giai \u0111o\u1ea1n th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, FDA hi\u1ec7n c\u0169ng \u0111\u00e3 ban h\u00e0nh h\u01b0\u1edbng d\u1eabn c\u1ee5 th\u1ec3 v\u1ec1 ti\u00eau chu\u1ea9n cGMP cho c\u00e1c s\u1ea3n ph\u1ea9m s\u1eed d\u1ee5ng ngay t\u1eeb giai \u0111o\u1ea1n 1, bao g\u1ed3m c\u1ea3 gi\u1ea3 d\u01b0\u1ee3c (9).&nbsp;<\/p>\n\n\n\n<p id=\"block-4d2120ec-89a5-4f5e-91db-d5b6c7a9d60c\">D\u1ef1a tr\u00ean c\u00e1c quy \u0111\u1ecbnh n\u00e0y, trong giai \u0111o\u1ea1n nghi\u00ean c\u1ee9u c\u01a1 b\u1ea3n t\u1ea1i ph\u00f2ng th\u00ed nghi\u1ec7m, quy tr\u00ecnh c\u00f3 th\u1ec3 ch\u01b0a c\u1ea7n tu\u00e2n th\u1ee7 ho\u00e0n to\u00e0n c\u00e1c ti\u00eau chu\u1ea9n GMP kh\u1eaft khe. Tuy nhi\u00ean, ngay khi s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c \u0111\u1ecbnh h\u01b0\u1edbng s\u1eed d\u1ee5ng trong c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng ho\u1eb7c \u0111i\u1ec1u tr\u1ecb tr\u00ean ng\u01b0\u1eddi, vi\u1ec7c n\u00e2ng c\u1ea5p v\u00e0 chuy\u1ec3n \u0111\u1ed5i sang quy tr\u00ecnh s\u1ea3n xu\u1ea5t \u0111\u1ea1t chu\u1ea9n cGMP l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o t\u00ednh ph\u00e1p l\u00fd v\u00e0 an to\u00e0n cho \u0111\u1ed1i t\u01b0\u1ee3ng s\u1eed d\u1ee5ng.&nbsp;<\/p>\n\n\n\n<p id=\"block-345abdbb-1091-42ff-9a40-145b589db0e0\">Do \u0111\u00f3, trong qu\u00e1 tr\u00ecnh nghi\u00ean c\u1ee9u, n\u00ean d\u00f9ng m\u00f4i tr\u01b0\u1eddng c\u00f3 phi\u00ean b\u1ea3n GMP ngay t\u1eeb giai \u0111o\u1ea1n R&amp;D n\u1ebfu c\u00f3 \u00fd \u0111\u1ecbnh \u0111i xa, \u0111\u1ec3 tr\u00e1nh vi\u1ec7c ph\u1ea3i l\u00e0m l\u1ea1i t\u1eeb \u0111\u1ea7u c\u00e1c th\u00ed nghi\u1ec7m ki\u1ec3m ch\u1ee9ng khi \u0111\u1ed5i m\u00f4i tr\u01b0\u1eddng \u1edf giai \u0111o\u1ea1n sau.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"block-881b28ab-7d26-4e20-99ee-eb5cccb7a5c5\"><span class=\"ez-toc-section\" id=\"Moi_truong_GMP_co_y_nghia_gi\"><\/span>M\u00f4i tr\u01b0\u1eddng GMP c\u00f3 \u00fd ngh\u0129a g\u00ec<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p id=\"block-3537db9c-61e4-49dc-a86b-a3ee31588931\">M\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y \u0111\u00f3ng vai tr\u00f2 then ch\u1ed1t cho c\u00e1c s\u1ea3n ph\u1ea9m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o, nh\u01b0 t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 (MSC), ho\u1eb7c s\u1ea3n ph\u1ea9m chi\u1ebft xu\u1ea5t t\u1eeb t\u1ebf b\u00e0o, nh\u01b0 t\u00fai ngo\u1ea1i b\u00e0o t\u1eeb t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 (MSC-EVs). N\u00f3 \u0111\u1ea3m b\u1ea3o s\u1ef1 t\u0103ng tr\u01b0\u1edfng v\u00e0 ch\u1ee9c n\u0103ng t\u1ed1i \u01b0u c\u1ee7a t\u1ebf b\u00e0o th\u00f4ng qua vi\u1ec7c cung c\u1ea5p c\u00e1c ch\u1ea5t dinh d\u01b0\u1ee1ng thi\u1ebft y\u1ebfu, y\u1ebfu t\u1ed1 t\u0103ng tr\u01b0\u1edfng v\u00e0 c\u00e1c th\u00e0nh ph\u1ea7n quan tr\u1ecdng kh\u00e1c.&nbsp;<\/p>\n\n\n\n<p id=\"block-5b24d5a8-212f-4fd3-b2c3-d337059cafab\">Vi\u1ec7c s\u1eed d\u1ee5ng m\u00f4i tr\u01b0\u1eddng \u0111\u1ea1t chu\u1ea9n GMP cho nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o s\u1ebd c\u00f3 nh\u1eefng \u01b0u \u0111i\u1ec3m sau:&nbsp;<\/p>\n\n\n\n<ul id=\"block-008de44a-355e-4cc3-a10e-6772136ac684\" class=\"wp-block-list\">\n<li><strong>Ki\u1ec3m so\u00e1t r\u1ee7i ro t\u1eeb \u0111\u1ea7u v\u00e0o:<\/strong> M\u1ecdi th\u00e0nh ph\u1ea7n trong m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y \u0111\u1ea1t chu\u1ea9n GMP ph\u1ea3i c\u00f3 ngu\u1ed3n g\u1ed1c r\u00f5 r\u00e0ng v\u00e0 \u0111\u1ea1t ch\u1ee9ng nh\u1eadn t\u01b0\u01a1ng \u1ee9ng.\u00a0<\/li>\n\n\n\n<li><strong>\u0110\u1ea3m b\u1ea3o t\u00ednh nh\u1ea5t qu\u00e1n gi\u1eefa c\u00e1c l\u00f4: <\/strong>Vi\u1ec7c ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd quy tr\u00ecnh s\u1ea3n xu\u1ea5t GMP cho ph\u00e9p ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o m\u1ecdi l\u00f4 s\u1ea3n ph\u1ea9m \u0111\u1ec1u c\u00f3 ch\u1ea5t l\u01b0\u1ee3ng nh\u01b0 nhau.\u00a0<\/li>\n\n\n\n<li><strong>C\u00f3 h\u1ed3 s\u01a1 t\u00e0i li\u1ec7u v\u00e0 c\u00f3 th\u1ec3 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c: <\/strong>M\u1ecdi b\u01b0\u1edbc trong quy tr\u00ecnh s\u1ea3n xu\u1ea5t \u0111\u1ec1u \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n h\u00f3a v\u00e0 c\u00f3 kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c ho\u00e0n ch\u1ec9nh.\u00a0<\/li>\n<\/ul>\n\n\n\n<p id=\"block-40df6502-747b-48a9-9640-ea424604a044\">Nh\u1eefng \u01b0u \u0111i\u1ec3m tr\u00ean c\u1ee7a m\u00f4i tr\u01b0\u1eddng GMP gi\u00fap doanh nghi\u1ec7p chu\u1ea9n h\u00f3a quy tr\u00ecnh s\u1ea3n xu\u1ea5t v\u00e0 d\u1ec5 d\u00e0ng \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u kh\u1eaft khe t\u1eeb c\u01a1 quan qu\u1ea3n l\u00fd trong n\u01b0\u1edbc l\u1eabn qu\u1ed1c t\u1ebf, t\u1ea1o ra m\u1ed9t b\u1ed9 h\u1ed3 s\u01a1 s\u1ea3n ph\u1ea9m ho\u00e0n ch\u1ec9nh, s\u1eb5n s\u00e0ng cho c\u00e1c giai \u0111o\u1ea1n th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng v\u00e0 th\u01b0\u01a1ng m\u1ea1i h\u00f3a&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"block-9a263c26-249f-47e1-acad-c7f3e5a9fa67\"><span class=\"ez-toc-section\" id=\"Ket_luan\"><\/span>K\u1ebft lu\u1eadn<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p id=\"block-e4dacd72-db01-4751-bb50-b2ef9bab1d75\">Vi\u1ec7c chuy\u1ec3n d\u1ecbch sang c\u00e1c d\u00f2ng m\u00f4i tr\u01b0\u1eddng c\u00f3 th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc x\u00e1c \u0111\u1ecbnh (CD) ho\u1eb7c kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c \u0111\u1ed9ng v\u1eadt (AOF) kh\u00f4ng n\u00ean \u0111\u01b0\u1ee3c xem l\u00e0 m\u1ed9t gi\u1ea3i ph\u00e1p \u201cv\u1ea1n n\u0103ng\u201d c\u00f3 th\u1ec3 ngay l\u1eadp t\u1ee9c gi\u1ea3i quy\u1ebft m\u1ecdi th\u00e1ch th\u1ee9c trong nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 (MSC) v\u00e0 s\u1ea3n xu\u1ea5t EV t\u1eeb MSC. Tuy nhi\u00ean, \u0111\u00e2y l\u00e0 y\u00eau c\u1ea7u n\u1ec1n t\u1ea3ng \u0111\u1ed1i v\u1edbi b\u1ea5t k\u1ef3 quy tr\u00ecnh n\u00e0o h\u01b0\u1edbng t\u1edbi m\u1ee5c ti\u00eau s\u1ea3n xu\u1ea5t MSC-EVs \u0111\u1ea1t chu\u1ea9n s\u1eed d\u1ee5ng trong l\u00e2m s\u00e0ng.&nbsp;<\/p>\n\n\n\n<p id=\"block-156d9bfa-1376-4fe5-a7e6-dd74da15015c\">Vi\u1ec7c l\u1ef1a ch\u1ecdn m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y c\u1ea7n \u0111\u01b0\u1ee3c \u0111\u1eb7t trong t\u01b0 duy s\u1ea3n xu\u1ea5t, v\u1edbi tr\u1ecdng t\u00e2m l\u00e0 t\u00ednh \u1ed5n \u0111\u1ecbnh trong v\u1eadn h\u00e0nh quy tr\u00ecnh, kh\u1ea3 n\u0103ng ki\u1ec3m so\u00e1t r\u1ee7i ro t\u1eeb c\u00e1c y\u1ebfu t\u1ed1 ngo\u1ea1i lai v\u00e0 \u0111\u1ed9 \u0111\u1ed3ng nh\u1ea5t c\u1ee7a s\u1ea3n ph\u1ea9m \u0111\u1ea7u ra. Trong l\u1ed9 tr\u00ecnh chu\u1ea9n h\u00f3a v\u00e0 th\u01b0\u01a1ng m\u1ea1i h\u00f3a, m\u1ed9t h\u1ec7 th\u1ed1ng nu\u00f4i c\u1ea5y c\u00f3 th\u00e0nh ph\u1ea7n x\u00e1c \u0111\u1ecbnh r\u00f5 r\u00e0ng, kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c \u0111\u1ed9ng v\u1eadt, theo ti\u00eau chu\u1ea9n GMP ch\u00ednh l\u00e0 n\u1ec1n t\u1ea3ng v\u1eefng ch\u1eafc cho s\u1ef1 ph\u00e1t tri\u1ec3n b\u1ec1n v\u1eefng c\u1ee7a d\u1ef1 \u00e1n.&nbsp;<\/p>\n\n\n\n<p id=\"block-a88a1982-eef0-4917-87e9-02f93ee45c0d\">D\u00f2ng m\u00f4i tr\u01b0\u1eddng <strong>CellCor\u2122 MSC CD AOF<\/strong> v\u00e0 <strong>CellCor<\/strong><strong><sup>TM<\/sup><\/strong><strong> EXO CD<\/strong> \u0111\u00e3 \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf chuy\u00ean bi\u1ec7t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o t\u00ednh \u0111\u1ed3ng nh\u1ea5t tuy\u1ec7t \u0111\u1ed1i cho quy tr\u00ecnh s\u1ea3n xu\u1ea5t, lo\u1ea1i b\u1ecf ho\u00e0n to\u00e0n c\u00e1c r\u1ee7i ro bi\u1ebfn thi\u00ean l\u00f4 v\u00e0 gi\u1ea3m t\u1ed1i thi\u1ec3u r\u1ee7i ro nhi\u1ec5m t\u1ea1p.<\/p>\n\n\n\n<p id=\"block-e7ea8e55-9cd3-48a3-960b-c6eef108c192\"><a href=\"https:\/\/biogroupvietnam.com\/vi\/san-pham\/cellcor-msc-cd-aof\/\"><strong>T\u00ecm hi\u1ec3u th\u00eam v\u1ec1 CellCor\u2122 MSC CD AOF<\/strong><\/a><\/p>\n\n\n\n<p id=\"block-306c9a4a-26c7-46a6-92c5-2fa5f197307d\"><a href=\"https:\/\/biogroupvietnam.com\/vi\/san-pham\/cellcor-exo-cd\/\"><strong>T\u00ecm hi\u1ec3u th\u00eam v\u1ec1 CellCor<\/strong><strong><sup>TM<\/sup><\/strong><strong> EXO CD<\/strong><\/a><\/p>\n\n\n\n<p id=\"block-0696db56-9c48-49a9-afb7-0020c8b7e93c\">\ud83d\udce9 <strong>Th\u00f4ng tin li\u00ean h\u1ec7:<\/strong><\/p>\n\n\n\n<ul id=\"block-4242d39c-6942-4274-a4a9-7c1480d61f67\" class=\"wp-block-list\">\n<li>Website: <a href=\"https:\/\/biogroupvietnam.com\/vi\/lien-he\/\">https:\/\/biogroupvietnam.com\/vi\/lien-he\/<\/a><\/li>\n\n\n\n<li>Hotline: +84 963 621 421\u00a0\u00a0<\/li>\n\n\n\n<li>Email: <a href=\"mailto:info@biogroupvietnam.com\">info@biogroupvietnam.com<\/a><\/li>\n<\/ul>\n\n\n\n<p id=\"block-65fc08f1-d8d8-4ffe-a745-3b3c27410ad7\"><strong>T\u00c0I LI\u1ec6U THAM KH\u1ea2O<\/strong><\/p>\n\n\n\n<ol id=\"block-edd27c41-ad8c-4254-8e64-0a7ab0a1e7e4\" class=\"wp-block-list\">\n<li>Xeno-free, Serum-free, What\u2019s for me? &#8211; Mesenchymal Stem Cell Media [Internet]. [cited 2026 Feb 2]. Available from: <a href=\"https:\/\/www.rndsystems.com\/blog\/xeno-free-serum-free-whats-me-mesenchymal-stem-cell-media\">https:\/\/www.rndsystems.com\/blog\/xeno-free-serum-free-whats-me-mesenchymal-stem-cell-media<\/a><\/li>\n\n\n\n<li>Culture Media Defined: Xeno-Free, Animal Origin-Free, and More | STEMCELL Technologies [Internet]. [cited 2026 Feb 2]. Available from: <a href=\"https:\/\/www.stemcell.com\/how-do-we-define-our-media.html\">https:\/\/www.stemcell.com\/how-do-we-define-our-media.html<\/a><\/li>\n\n\n\n<li>Kim Schrag, Manisha Sahni, Scott Wilson, Chas Hernandez, Andrew Christie. Strategies for Investigation of Cell Culture Media Failures: Case Study of an Insect Cell Culture Medium Failure Due to Yeastolate [Internet]. Sigma-Aldrich; [cited 2026 Feb 3]. Available from: <a href=\"https:\/\/www.sigmaaldrich.com\/deepweb\/assets\/sigmaaldrich\/marketing\/global\/documents\/237\/010\/cell-culture-media-failures.pdf\">https:\/\/www.sigmaaldrich.com\/deepweb\/assets\/sigmaaldrich\/marketing\/global\/documents\/237\/010\/cell-culture-media-failures.pdf<\/a><\/li>\n\n\n\n<li>Zheng X, Baker H, Hancock WS, Fawaz F, McCaman M, Pungor Jr. E. Proteomic Analysis for the Assessment of Different Lots of Fetal Bovine Serum as a Raw Material for Cell Culture. Part IV. Application of Proteomics to the Manufacture of Biological Drugs. Biotechnol Prog. 2006;22(5):1294\u2013300.\u00a0\u00a0<\/li>\n\n\n\n<li>ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin &#8211; Scientific guideline | European Medicines Agency (EMA) [Internet]. 1997 [cited 2026 Feb 2]. Available from: <a href=\"https:\/\/www.ema.europa.eu\/en\/ich-q5ar2-guideline-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-or-animal-origin-scientific-guideline\">https:\/\/www.ema.europa.eu\/en\/ich-q5ar2-guideline-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-or-animal-origin-scientific-guideline<\/a><\/li>\n\n\n\n<li>ICH Q7 Good manufacturing practice for active pharmaceutical ingredients &#8211; Scientific guideline | European Medicines Agency (EMA) [Internet]. 2000 [cited 2026 Feb 3]. Available from: <a href=\"https:\/\/www.ema.europa.eu\/en\/ich-q7-good-manufacturing-practice-active-pharmaceutical-ingredients-scientific-guideline\">https:\/\/www.ema.europa.eu\/en\/ich-q7-good-manufacturing-practice-active-pharmaceutical-ingredients-scientific-guideline<\/a><\/li>\n\n\n\n<li>Medicine C for V. CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products [Internet]. FDA; 2022 [cited 2026 Feb 3]. Available from: <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/cvm-gfi-253-current-good-manufacturing-practice-animal-cells-tissues-and-cell-and-tissue-based\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/cvm-gfi-253-current-good-manufacturing-practice-animal-cells-tissues-and-cell-and-tissue-based<\/a><\/li>\n\n\n\n<li>New guidelines on good manufacturing practices for advanced therapies | European Medicines Agency (EMA) [Internet]. 2017 [cited 2026 Feb 3]. Available from: <a href=\"https:\/\/www.ema.europa.eu\/en\/news\/new-guidelines-good-manufacturing-practices-advanced-therapies\">https:\/\/www.ema.europa.eu\/en\/news\/new-guidelines-good-manufacturing-practices-advanced-therapies<\/a><\/li>\n\n\n\n<li>Research C for DE and. Current Good Manufacturing Practice for Phase 1 Investigational Drugs [Internet]. FDA; 2023 [cited 2026 Feb 3]. Available from: <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/current-good-manufacturing-practice-phase-1-investigational-drugs\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/current-good-manufacturing-practice-phase-1-investigational-drugs<\/a><\/li>\n\n\n\n<li>Research C for DE and. Facts About the Current Good Manufacturing Practice (CGMP). FDA [Internet]. 2025 Nov 21 [cited 2026 Feb 3]; Available from: <a href=\"https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/facts-about-current-good-manufacturing-practice-cgmp\">https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/facts-about-current-good-manufacturing-practice-cgmp<\/a><\/li>\n<\/ol>\n","protected":false},"featured_media":9826,"parent":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-9831","service","type-service","status-publish","has-post-thumbnail","hentry","service-category-knowledge-base"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Biogroup Vietnam<\/title>\n<meta name=\"description\" content=\"M\u00f4i tr\u01b0\u1eddng CD, AOF l\u00e0 g\u00ec v\u00e0 v\u00ec sao c\u1ea7n thi\u1ebft trong nu\u00f4i c\u1ea5y MSC, s\u1ea3n xu\u1ea5t MSC-EV \u0111\u1ea1t chu\u1ea9n GMP? 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