{"id":9570,"date":"2025-01-16T13:41:56","date_gmt":"2025-01-16T06:41:56","guid":{"rendered":"https:\/\/biogroupvietnam.com\/?p=9570"},"modified":"2026-01-30T13:25:54","modified_gmt":"2026-01-30T06:25:54","slug":"chat-luong-vat-lieu-phu-tro-trong-san-xuat-tri-lieu-te-bao-bat-dau-tu-dau","status":"publish","type":"post","link":"https:\/\/biogroupvietnam.com\/en\/blog\/chat-luong-vat-lieu-phu-tro-trong-san-xuat-tri-lieu-te-bao-bat-dau-tu-dau\/","title":{"rendered":"Ch\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 trong s\u1ea3n xu\u1ea5t tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o: B\u1eaft \u0111\u1ea7u t\u1eeb \u0111\u00e2u?"},"content":{"rendered":"\n<p>V\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 bao g\u1ed3m h\u00f3a ch\u1ea5t\/ m\u00f4i tr\u01b0\u1eddng ph\u00e2n l\u1eadp t\u1ebf b\u00e0o, m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y v\u00e0 m\u00f4i tr\u01b0\u1eddng b\u1ea3o qu\u1ea3n l\u1ea1nh t\u1ebf b\u00e0o, v\u00e0 v\u1eadt t\u01b0 ti\u00eau hao d\u00f9ng m\u1ed9t l\u1ea7n nh\u01b0 v\u1eadt t\u01b0 nh\u1ef1a v\u00e0 t\u00fai x\u1eed l\u00fd v\u00e0 l\u01b0u tr\u1eef t\u1ebf b\u00e0o. \u201cCh\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3\u201d \u0111\u1ec1 c\u1eadp \u0111\u1ebfn qu\u00e1 tr\u00ecnh thi\u1ebft l\u1eadp ngu\u1ed3n g\u1ed1c, danh t\u00ednh, \u0111\u1ed9 tinh khi\u1ebft, an to\u00e0n sinh h\u1ecdc v\u00e0 t\u00ednh ph\u00f9 h\u1ee3p chung c\u1ee7a m\u1ed9t v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 nh\u1ea5t \u0111\u1ecbnh.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter\"><img decoding=\"async\" src=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/09\/wCOVcAaFlAl4du7eFjCTYHNYrKqydZvyTlysajPq.png\" alt=\"T\u00ecm hi\u1ec3u ch\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 trong s\u1ea3n xu\u1ea5t tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o\"\/><figcaption class=\"wp-element-caption\"><em>T\u00ecm hi\u1ec3u ch\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 trong s\u1ea3n xu\u1ea5t tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o<\/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\/blog\/chat-luong-vat-lieu-phu-tro-trong-san-xuat-tri-lieu-te-bao-bat-dau-tu-dau\/#Gioi_thieu\" >Gi\u1edbi thi\u1ec7u<\/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\/blog\/chat-luong-vat-lieu-phu-tro-trong-san-xuat-tri-lieu-te-bao-bat-dau-tu-dau\/#Vat_lieu_phu_tro_la_gi\" >V\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 l\u00e0 g\u00ec?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/chat-luong-vat-lieu-phu-tro-trong-san-xuat-tri-lieu-te-bao-bat-dau-tu-dau\/#Loai_chung_nhan_nao_la_bat_buoc_doi_voi_vat_lieu_phu_tro\" >Lo\u1ea1i ch\u1ee9ng nh\u1eadn n\u00e0o l\u00e0 b\u1eaft bu\u1ed9c \u0111\u1ed1i v\u1edbi v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/chat-luong-vat-lieu-phu-tro-trong-san-xuat-tri-lieu-te-bao-bat-dau-tu-dau\/#%E2%80%9CCap_Grade%E2%80%9D_nao_cua_vat_lieu_phu_tro_la_can_thiet_cho_san_xuat_te_bao_tri_lieu\" >&#8220;C\u1ea5p (Grade)&#8221; n\u00e0o c\u1ee7a v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 l\u00e0 c\u1ea7n thi\u1ebft cho s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/chat-luong-vat-lieu-phu-tro-trong-san-xuat-tri-lieu-te-bao-bat-dau-tu-dau\/#Cac_nha_san_xuat_va_nha_cung_cap_co_the_lam_viec_cung_nhau_nhu_the_nao_de_toi_uu_chat_luong_vat_lieu_phu_tro\" >C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 nh\u00e0 cung c\u1ea5p c\u00f3 th\u1ec3 l\u00e0m vi\u1ec7c c\u00f9ng nhau nh\u01b0 th\u1ebf n\u00e0o \u0111\u1ec3 &nbsp;t\u1ed1i \u01b0u ch\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3?<\/a><\/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\/blog\/chat-luong-vat-lieu-phu-tro-trong-san-xuat-tri-lieu-te-bao-bat-dau-tu-dau\/#Trach_nhiem_cua_nguoi_su_dung_va_nha_cung_cap_doi_voi_viec_su_dung_vat_lieu_phu_tro\" >Tr\u00e1ch nhi\u1ec7m c\u1ee7a ng\u01b0\u1eddi s\u1eed d\u1ee5ng v\u00e0 nh\u00e0 cung c\u1ea5p \u0111\u1ed1i v\u1edbi vi\u1ec7c s\u1eed d\u1ee5ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Gioi_thieu\"><\/span><strong>Gi\u1edbi thi\u1ec7u<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>V\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 (Ancillary materials) l\u00e0 m\u1ed9t ph\u1ea7n quan tr\u1ecdng c\u1ee7a qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o. Tuy nhi\u00ean, vi\u1ec7c l\u1ef1a ch\u1ecdn v\u00e0 \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng c\u00e1c v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 c\u00f3 th\u1ec3 l\u00e0 m\u1ed9t th\u00e1ch th\u1ee9c v\u00e0 kh\u00f3 hi\u1ec3u \u0111\u1ed1i v\u1edbi c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o.<\/p>\n\n\n\n<p>V\u00ed d\u1ee5, c\u00e1c quy \u0111\u1ecbnh c\u1ee5 th\u1ec3 v\u1ec1 v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 v\u1eabn ch\u01b0a \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n, d\u1eabn \u0111\u1ebfn s\u1ef1 m\u01a1 h\u1ed3 v\u1ec1 quy \u0111\u1ecbnh \u0111\u1ed1i v\u1edbi c\u1ea3 nh\u00e0 s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o v\u00e0 nh\u00e0 cung c\u1ea5p v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3. T\u01b0\u01a1ng t\u1ef1, kh\u00f4ng c\u00f3 ti\u00eau chu\u1ea9n s\u1ea3n xu\u1ea5t \u201cc\u1ea5p v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3\u201d duy nh\u1ea5t ho\u1eb7c b\u1ea5t k\u1ef3 ti\u00eau chu\u1ea9n h\u00f3a n\u00e0o v\u1ec1 c\u00e1c tuy\u00ean b\u1ed1 tu\u00e2n th\u1ee7 kh\u00e1c, ch\u1eb3ng h\u1ea1n nh\u01b0 <strong>c\u1ea5p ph\u1ee5 tr\u1ee3, c\u1ea5p l\u00e2m s\u00e0ng, c\u1ea5p GMP v\u00e0 kh\u00f4ng c\u00f3 th\u00e0nh ph\u1ea7n \u0111\u1ed9ng v\u1eadt<\/strong>. V\u00ec nh\u1eefng l\u00fd do nh\u01b0 v\u1eady, c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o c\u00f3 th\u1ec3 kh\u00f3 x\u00e1c \u0111\u1ecbnh ch\u1ebf \u0111\u1ed9 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n c\u1ea7n thi\u1ebft cho m\u1ed9t v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 c\u1ee5 th\u1ec3. \u0110\u1ec3 l\u00e0m r\u00f5 nh\u1eefng v\u1ea5n \u0111\u1ec1 n\u00e0y, b\u1ea3n tin k\u1ef9 thu\u1eadt n\u00e0y th\u1ea3o lu\u1eadn v\u1ec1 c\u00e1c nguy\u00ean t\u1eafc c\u01a1 b\u1ea3n c\u1ee7a ch\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 c\u00f3 tham kh\u1ea3o \u0111\u1ebfn m\u1ed9t c\u00f4ng b\u1ed1 g\u1ea7n \u0111\u00e2y tr\u00ean t\u1ea1p ch\u00ed Cytotherapy1<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Vat_lieu_phu_tro_la_gi\"><\/span><strong>V\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 l\u00e0 g\u00ec?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>V\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 l\u00e0 c\u00e1c th\u00e0nh ph\u1ea7n, h\u00f3a ch\u1ea5t v\u00e0 v\u1eadt li\u1ec7u \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o nh\u01b0ng kh\u00f4ng nh\u1eb1m m\u1ee5c \u0111\u00edch tr\u1edf th\u00e0nh m\u1ed9t ph\u1ea7n c\u1ee7a s\u1ea3n ph\u1ea9m cu\u1ed1i c\u00f9ng. V\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 bao g\u1ed3m h\u00f3a ch\u1ea5t\/ m\u00f4i tr\u01b0\u1eddng ph\u00e2n l\u1eadp t\u1ebf b\u00e0o, m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y v\u00e0 m\u00f4i tr\u01b0\u1eddng b\u1ea3o qu\u1ea3n l\u1ea1nh t\u1ebf b\u00e0o, v\u00e0 v\u1eadt t\u01b0 ti\u00eau hao d\u00f9ng m\u1ed9t l\u1ea7n nh\u01b0 v\u1eadt t\u01b0 nh\u1ef1a v\u00e0 t\u00fai x\u1eed l\u00fd v\u00e0 l\u01b0u tr\u1eef t\u1ebf b\u00e0o. Thu\u1eadt ng\u1eef \u201cv\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3\u201d kh\u00f4ng \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn tr\u00ean to\u00e0n c\u1ea7u b\u1edfi c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd v\u00e0 c\u00f3 \u201ct\u00ean g\u1ecdi\u201d kh\u00e1c nhau gi\u1eefa c\u00e1c khu v\u1ef1c (v\u00ed d\u1ee5: v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 \u201cnguy\u00ean li\u1ec7u th\u00f4\u201d \u1edf Ch\u00e2u \u00c2u).<\/p>\n\n\n\n<p>M\u1eb7c d\u00f9 v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 kh\u00f4ng nh\u1eb1m m\u1ee5c \u0111\u00edch c\u00f3 m\u1eb7t trong s\u1ea3n ph\u1ea9m cu\u1ed1i c\u00f9ng, ch\u00fang v\u1eabn c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn t\u00ednh an to\u00e0n, hi\u1ec7u qu\u1ea3 v\u00e0 t\u00ednh \u0111\u1ed3ng nh\u1ea5t c\u1ee7a s\u1ea3n ph\u1ea9m. Do \u0111\u00f3, \u0111i\u1ec1u quan tr\u1ecdng l\u00e0 c\u00e1c v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 ph\u1ea3i \u0111\u01b0\u1ee3c xem x\u00e9t k\u1ef9 l\u01b0\u1ee1ng v\u1ec1 \u0111\u1eb7c \u0111i\u1ec3m h\u00f3a h\u1ecdc v\u00e0 sinh h\u1ecdc, c\u0169ng nh\u01b0 t\u00e1c \u0111\u1ed9ng c\u1ee7a ch\u00fang \u0111\u1ed1i v\u1edbi s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o cu\u1ed1i c\u00f9ng.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Loai_chung_nhan_nao_la_bat_buoc_doi_voi_vat_lieu_phu_tro\"><\/span><strong>Lo\u1ea1i ch\u1ee9ng nh\u1eadn n\u00e0o l\u00e0 b\u1eaft bu\u1ed9c \u0111\u1ed1i v\u1edbi v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u201cCh\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3\u201d \u0111\u1ec1 c\u1eadp \u0111\u1ebfn qu\u00e1 tr\u00ecnh thi\u1ebft l\u1eadp ngu\u1ed3n g\u1ed1c, danh t\u00ednh, \u0111\u1ed9 tinh khi\u1ebft, an to\u00e0n sinh h\u1ecdc v\u00e0 t\u00ednh ph\u00f9 h\u1ee3p chung c\u1ee7a m\u1ed9t v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 nh\u1ea5t \u0111\u1ecbnh. Quy tr\u00ecnh ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng c\u1ee5 th\u1ec3 c\u1ea7n thi\u1ebft cho m\u1ed9t v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 ph\u1ee5 thu\u1ed9c v\u00e0o nhi\u1ec1u y\u1ebfu t\u1ed1, bao g\u1ed3m lo\u1ea1i v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3, lo\u1ea1i s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o \u0111ang \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t v\u00e0 giai \u0111o\u1ea1n s\u1ea3n xu\u1ea5t m\u00e0 v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng.V\u00ec v\u1eady, kh\u00f4ng th\u1ec3 cung c\u1ea5p m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng \u201cone-size-fits-all\u201d ph\u00f9 h\u1ee3p v\u1edbi m\u1ecdi t\u00ecnh hu\u1ed1ng. Thay v\u00e0o \u0111\u00f3, c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t ph\u1ea3i thi\u1ebft k\u1ebf c\u00e1c ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a ri\u00eang h\u1ecd b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng c\u00e1ch ti\u1ebfp c\u1eadn d\u1ef1a tr\u00ean r\u1ee7i ro v\u00e0 hi\u1ec3u bi\u1ebft v\u1ec1 c\u00e1c h\u01b0\u1edbng d\u1eabn v\u00e0 quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh.<\/p>\n\n\n\n<p>M\u1eb7c d\u00f9 v\u1eabn ch\u01b0a c\u00f3 quy \u0111\u1ecbnh c\u1ee5 th\u1ec3 v\u00e0 ch\u00ednh x\u00e1c cho v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3, ch\u01b0\u01a1ng &lt;1043&gt; c\u1ee7a D\u01b0\u1ee3c \u0111i\u1ec3n M\u1ef9 (USP) cung c\u1ea5p h\u01b0\u1edbng d\u1eabn \u0111\u1ec3 ph\u00e1t tri\u1ec3n c\u00e1c ch\u01b0\u01a1ng tr\u00ecnh ch\u1ee9ng ch\u1ec9 v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 th\u00edch h\u1ee3p. C\u00e1c ch\u01b0\u01a1ng tr\u00ecnh nh\u01b0 v\u1eady n\u00ean t\u1eadp trung v\u00e0o 05 l\u0129nh v\u1ef1c: (1) x\u00e1c \u0111\u1ecbnh, (2) l\u1ef1a ch\u1ecdn v\u00e0 t\u00ednh ph\u00f9 h\u1ee3p \u0111\u1ec3 s\u1eed d\u1ee5ng trong s\u1ea3n xu\u1ea5t, (3) \u0111\u1eb7c t\u00ednh, (4) n\u0103ng l\u1ef1c c\u1ee7a nh\u00e0 cung c\u1ea5p, v\u00e0 (5) \u0111\u1ea3m b\u1ea3o v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng. \u0110\u1ec3 bi\u1ebft th\u00eam th\u00f4ng tin v\u1ec1 t\u1eebng l\u0129nh v\u1ef1c n\u00e0y, h\u00e3y tham kh\u1ea3o d\u01b0\u1ee3c \u0111i\u1ec3n USP &lt;1043&gt;.<\/p>\n\n\n\n<p>M\u1ee9c \u0111\u1ed9 r\u1ee7i ro li\u00ean quan \u0111\u1ebfn v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 s\u1ebd \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u00e1c ho\u1ea1t \u0111\u1ed9ng \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng c\u1ea7n thi\u1ebft. D\u01b0\u1ee3c \u0111i\u1ec3n USP &lt;1043&gt; cung c\u1ea5p m\u1ed9t khu\u00f4n kh\u1ed5 \u0111\u1ec3 ph\u00e2n lo\u1ea1i v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 th\u00e0nh b\u1ed1n c\u1ea5p kh\u00e1c nhau d\u1ef1a tr\u00ean r\u1ee7i ro. \u0110\u1ed1i v\u1edbi v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 \u1edf C\u1ea5p 1 (r\u1ee7i ro th\u1ea5p, ch\u1ea5t l\u01b0\u1ee3ng cao), nh\u00e0 s\u1ea3n xu\u1ea5t c\u00f3 th\u1ec3 c\u1ea7n ph\u1ea3i tham kh\u1ea3o ch\u00e9o file D\u01b0\u1ee3c ph\u1ea9m (DMF; n\u1ebfu c\u00f3), l\u1ea5y ch\u1ee9ng ch\u1ec9 ph\u00e2n t\u00edch (CoAs), \u0111\u00e1nh gi\u00e1 lo\u1ea1i b\u1ecf kh\u1ecfi s\u1ea3n ph\u1ea9m cu\u1ed1i c\u00f9ng v\u00e0 \u1ea3nh h\u01b0\u1edfng c\u1ee7a s\u1ef1 bi\u1ebfn thi\u00ean theo l\u00f4, v\u00e0 ti\u1ebfn h\u00e0nh c\u00e1c nghi\u00ean c\u1ee9u v\u1ec1 \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh.<\/p>\n\n\n\n<p>\u0110\u1ed1i v\u1edbi v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 \u1edf C\u1ea5p 4 (r\u1ee7i ro cao, \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u1ed1i thi\u1ec3u), nh\u00e0 s\u1ea3n xu\u1ea5t s\u1ebd c\u1ea7n th\u1ef1c hi\u1ec7n t\u1ea5t c\u1ea3 c\u00e1c ho\u1ea1t \u0111\u1ed9ng \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea \u1edf tr\u00ean, c\u0169ng nh\u01b0 tr\u00ecnh \u0111\u1ed9 chuy\u00ean m\u00f4n s\u00e2u h\u01a1n, ch\u1eb3ng h\u1ea1n nh\u01b0 x\u00e1c nh\u1eadn k\u1ebft qu\u1ea3 CoA quan tr\u1ecdng, ti\u1ebfn h\u00e0nh th\u1eed nghi\u1ec7m t\u00e1c nh\u00e2n nhanh ch\u00f3ng v\u00e0 c\u00f3 th\u1ec3 ho\u1ea1t \u0111\u1ed9ng v\u1edbi nh\u00e0 cung c\u1ea5p \u0111\u1ec3 n\u00e2ng c\u1ea5p quy tr\u00ecnh s\u1ea3n xu\u1ea5t v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 theo ti\u00eau chu\u1ea9n GMP hi\u1ec7n h\u00e0nh.<\/p>\n\n\n\n<p>S\u01a1 l\u01b0\u1ee3c tr\u00ean ch\u1ec9 l\u00e0 m\u1ed9t c\u00e1i nh\u00ecn t\u1ed5ng quan r\u1ea5t cao v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3. \u0110\u1ec3 bi\u1ebft th\u00eam chi ti\u1ebft, tham kh\u1ea3o d\u01b0\u1ee3c \u0111i\u1ec3n USP &lt;1043&gt; v\u00e0 Solomon et al.1<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E2%80%9CCap_Grade%E2%80%9D_nao_cua_vat_lieu_phu_tro_la_can_thiet_cho_san_xuat_te_bao_tri_lieu\"><\/span><strong>&#8220;C\u1ea5p (Grade)&#8221; n\u00e0o c\u1ee7a v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 l\u00e0 c\u1ea7n thi\u1ebft cho s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Tr\u00e1i ng\u01b0\u1ee3c v\u1edbi ni\u1ec1m tin ph\u1ed5 bi\u1ebfn, \u1edf Hoa K\u1ef3 kh\u00f4ng c\u00f3 c\u1ea5p v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 c\u1ee5 th\u1ec3 n\u00e0o \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u \u0111\u1ec3 s\u1eed d\u1ee5ng trong s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o. Tuy nhi\u00ean, v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t theo h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng cao v\u1edbi c\u00e1c quy tr\u00ecnh s\u1ea3n xu\u1ea5t \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd s\u1ebd gi\u1ea3m b\u1edbt g\u00e1nh n\u1eb7ng v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng cho m\u1ed9t nh\u00e0 s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o. V\u00ec l\u00fd do n\u00e0y, c\u00f3 th\u1ec3 \u01b0u ti\u00ean s\u1eed d\u1ee5ng ngu\u1ed3n v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t theo cGMP, ho\u1eb7c c\u00e1c s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u ho\u1eb7c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t, r\u00f5 r\u00e0ng ho\u1eb7c \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p.<\/p>\n\n\n\n<p>Tuy nhi\u00ean, l\u01b0u \u00fd r\u1eb1ng ngay c\u1ea3 m\u1ed9t s\u1ea3n ph\u1ea9m \u0111i\u1ec1u tr\u1ecb \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng nh\u01b0 m\u1ed9t v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 c\u0169ng ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn cho c\u00e1c \u1ee9ng d\u1ee5ng ngo\u00e0i m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng c\u1ee7a n\u00f3. Ng\u01b0\u1eddi s\u1ea3n xu\u1ea5t c\u00f3 th\u1ec3 kh\u00f4ng c\u1ea7n l\u1eb7p l\u1ea1i c\u00e1c th\u1eed nghi\u1ec7m m\u00e0 nh\u00e0 cung c\u1ea5p v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 \u0111\u00e3 th\u1ef1c hi\u1ec7n trong qu\u00e1 tr\u00ecnh \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u, nh\u01b0ng ng\u01b0\u1eddi s\u1ea3n xu\u1ea5t v\u1eabn s\u1ebd c\u1ea7n \u0111\u00e1nh gi\u00e1 t\u00ednh \u1ed5n \u0111\u1ecbnh v\u00e0 hi\u1ec7u su\u1ea5t trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t, c\u0169ng nh\u01b0 \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng c\u1ee7a thay \u0111\u1ed5i s\u1ed1 l\u00f4 \u201clot-to-lot\u201d c\u1ee7a v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 l\u00ean s\u1ea3n ph\u1ea9m cu\u1ed1i c\u00f9ng.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Cac_nha_san_xuat_va_nha_cung_cap_co_the_lam_viec_cung_nhau_nhu_the_nao_de_toi_uu_chat_luong_vat_lieu_phu_tro\"><\/span><strong>C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 nh\u00e0 cung c\u1ea5p c\u00f3 th\u1ec3 l\u00e0m vi\u1ec7c c\u00f9ng nhau nh\u01b0 th\u1ebf n\u00e0o \u0111\u1ec3 &nbsp;t\u1ed1i \u01b0u ch\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Trong khi ch\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 cu\u1ed1i c\u00f9ng l\u00e0 tr\u00e1ch nhi\u1ec7m c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o, n\u00f3 c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n hi\u1ec7u qu\u1ea3 h\u01a1n nhi\u1ec1u th\u00f4ng qua quan h\u1ec7 \u0111\u1ed1i t\u00e1c ch\u1eb7t ch\u1ebd v\u1edbi nh\u00e0 cung c\u1ea5p v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3. C\u00e1c nh\u00e0 cung c\u1ea5p c\u00f3 th\u1ec3 h\u1ed7 tr\u1ee3 nh\u00e0 s\u1ea3n xu\u1ea5t theo nhi\u1ec1u c\u00e1ch, ch\u1eb3ng h\u1ea1n nh\u01b0 b\u1eb1ng c\u00e1ch cung c\u1ea5p t\u00e0i li\u1ec7u ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m (CoA,\u2026), cho ph\u00e9p \u0111\u00e1nh gi\u00e1 c\u01a1 s\u1edf c\u1ee7a h\u1ecd, th\u00f4ng b\u00e1o cho nh\u00e0 s\u1ea3n xu\u1ea5t v\u1ec1 nh\u1eefng thay \u0111\u1ed5i \u0111\u1ed1i v\u1edbi v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 tr\u01b0\u1edbc khi nh\u1eefng thay \u0111\u1ed5i \u0111\u00f3 c\u00f3 hi\u1ec7u l\u1ef1c, chu\u1ea9n b\u1ecb v\u00e0 g\u1eedi t\u00e0i li\u1ec7u DMF, \u0111\u1ed3ng th\u1eddi cung c\u1ea5p m\u1ee9c \u0111\u1ed9 th\u1eed nghi\u1ec7m cao h\u01a1n ho\u1eb7c c\u00f4ng th\u1ee9c t\u00f9y ch\u1ec9nh.<\/p>\n\n\n\n<p>B\u1ea3ng 2 trong b\u00e0i b\u00e1o c\u1ee7a t\u00e1c gi\u1ea3 Solomon et al.1 cung c\u1ea5p m\u1ed9t b\u1ea3n t\u00f3m t\u1eaft r\u00f5 r\u00e0ng v\u1ec1 tr\u00e1ch nhi\u1ec7m gi\u1ea3i tr\u00ecnh t\u01b0\u01a1ng \u1ee9ng c\u1ee7a c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o v\u00e0 nh\u00e0 cung c\u1ea5p v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Trach_nhiem_cua_nguoi_su_dung_va_nha_cung_cap_doi_voi_viec_su_dung_vat_lieu_phu_tro\"><\/span><strong>Tr\u00e1ch nhi\u1ec7m c\u1ee7a ng\u01b0\u1eddi s\u1eed d\u1ee5ng v\u00e0 nh\u00e0 cung c\u1ea5p \u0111\u1ed1i v\u1edbi vi\u1ec7c s\u1eed d\u1ee5ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>C\u00e1c ho\u1ea1t \u0111\u1ed9ng<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Nh\u00e0 cung c\u1ea5p<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\"><strong>Ng\u01b0\u1eddi s\u1eed d\u1ee5ng<\/strong><\/td><\/tr><tr><td>Th\u1ef1c hi\u1ec7n \u1ee9ng d\u1ee5ng d\u1ef1 \u0111\u1ecbnh<\/td><td class=\"has-text-align-center\" data-align=\"center\">&nbsp;<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>Cung c\u1ea5p CoA, CoC, CoO cho v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><td class=\"has-text-align-center\" data-align=\"center\">&nbsp;<\/td><\/tr><tr><td>X\u00e1c minh n\u01b0\u1edbc xu\u1ea5t x\u1ee9 (CO) \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 l\u00e0 an to\u00e0n \u0111\u1ed1i v\u1edbi c\u00e1c b\u1ec7nh \u0111\u1ed9ng v\u1eadt c\u00f3 li\u00ean quan \u0111\u1ebfn ngu\u1ed3n v\u1eadt li\u1ec7u (v\u00ed d\u1ee5: BSE \/ TSE)<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>Ti\u1ebfn h\u00e0nh \u0111\u00e1nh gi\u00e1 r\u1ee7i ro \u0111\u1ed1i v\u1edbi vi\u1ec7c s\u1eed d\u1ee5ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3, d\u1ef1a tr\u00ean th\u00f4ng tin do nh\u00e0 cung c\u1ea5p cung c\u1ea5p ho\u1eb7c ph\u1ed1i h\u1ee3p v\u1edbi nh\u00e0 cung c\u1ea5p, v\u00ed d\u1ee5, c\u00e1c ph\u01b0\u01a1ng th\u1ee9c h\u1ecfng h\u00f3c v\u00e0 ph\u00e2n t\u00edch \u1ea3nh h\u01b0\u1edfng<\/td><td class=\"has-text-align-center\" data-align=\"center\">&nbsp;<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>Thi\u1ebft l\u1eadp v\u00e0 th\u1ef1c hi\u1ec7n k\u1ebf ho\u1ea1ch \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng cho v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3<\/td><td class=\"has-text-align-center\" data-align=\"center\">&nbsp;<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>X\u00e1c nh\u1eadn k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m CoA quan tr\u1ecdng \u0111\u1ed1i v\u1edbi s\u1ea3n ph\u1ea9m t\u1ebf b\u00e0o (v\u00ed d\u1ee5: th\u1eed nghi\u1ec7m ch\u1ee9c n\u0103ng)<\/td><td class=\"has-text-align-center\" data-align=\"center\">&nbsp;<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>Ki\u1ec3m tra \u0111\u1eb7c t\u00ednh c\u1ee7a v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 v\u00e0 \u0111\u1eb7t th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt (v\u00ed d\u1ee5: danh t\u00ednh, \u0111\u1ed9 tinh khi\u1ebft, ch\u1ee9c n\u0103ng, v\u1eadt li\u1ec7u ch\u1ed1ng virus, ngu\u1ed3n g\u1ed1c \u0111\u1ed9ng v\u1eadt, v.v.)<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>\u0110\u00e1nh gi\u00e1 \u1ea3nh h\u01b0\u1edfng c\u1ee7a s\u1ef1 thay \u0111\u1ed5i t\u1eebng l\u00f4 c\u1ee7a v\u1eadt li\u1ec7u ph\u1ee5 \u0111\u1ed1i v\u1edbi s\u1ea3n ph\u1ea9m t\u1ebf b\u00e0o cu\u1ed1i c\u00f9ng<\/td><td class=\"has-text-align-center\" data-align=\"center\">&nbsp;<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>X\u00e1c \u0111\u1ecbnh xem c\u00f3 c\u1ea7n t\u00ednh t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc, ph\u00e2n ph\u1ed1i sinh h\u1ecdc, \u0111\u1ed9c t\u00ednh t\u1ebf b\u00e0o ho\u1eb7c th\u1eed nghi\u1ec7m t\u00e1c nh\u00e2n ti\u1ec1m t\u00e0ng hay kh\u00f4ng (ho\u1eb7c k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m c\u00f3 th\u1ec3 c\u00f3 s\u1eb5n t\u1eeb nh\u00e0 cung c\u1ea5p, n\u1ebfu c\u00f3)<\/td><td class=\"has-text-align-center\" data-align=\"center\">&nbsp;<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>\u0110\u00e1nh gi\u00e1 s\u1ef1 hi\u1ec7n di\u1ec7n c\u1ee7a v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 c\u00f2n s\u00f3t l\u1ea1i trong s\u1ea3n ph\u1ea9m t\u1ebf b\u00e0o cu\u1ed1i c\u00f9ng<\/td><td class=\"has-text-align-center\" data-align=\"center\">&nbsp;<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>\u0110\u00e1nh gi\u00e1 \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh c\u1ee7a v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>\u0110\u00e1nh gi\u00e1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n cho nh\u00e0 cung c\u1ea5p v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 (v\u00ed d\u1ee5: \u0111\u00e1nh gi\u00e1 nh\u00e0 cung c\u1ea5p)<\/td><td class=\"has-text-align-center\" data-align=\"center\">&nbsp;<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>Th\u1ef1c hi\u1ec7n th\u1ecfa thu\u1eadn cung c\u1ea5p v\u00e0 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>Th\u1ef1c hi\u1ec7n c\u00e1c ti\u00eau chu\u1ea9n s\u1ea3n xu\u1ea5t cao h\u01a1n, c\u00f4ng th\u1ee9c t\u00f9y ch\u1ec9nh ho\u1eb7c thay th\u1ebf c\u00e1c th\u00e0nh ph\u1ea7n kh\u00f4ng \u0111\u1ea1t ti\u00eau chu\u1ea9n<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>N\u00e2ng c\u1ea5p quy tr\u00ecnh s\u1ea3n xu\u1ea5t \u0111\u1ed1i v\u1edbi v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 theo vi\u1ec7c tu\u00e2n th\u1ee7 cGMP (t\u1ee9c l\u00e0 trong m\u1ed9t s\u1ed1 tr\u01b0\u1eddng h\u1ee3p, c\u00f3 th\u1ec3 c\u00f3 c\u00e1c y\u00eau c\u1ea7u v\u1ec1 chi ph\u00ed chung v\u00e0 r\u1ee7i ro)<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><\/tr><tr><td>Th\u00f4ng b\u00e1o \u0111\u1ebfn ng\u01b0\u1eddi s\u1eed d\u1ee5ng v\u1ec1 b\u1ea5t k\u1ef3 thay \u0111\u1ed5i n\u00e0o trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t v\u1eadt li\u1ec7u ph\u1ee5 ho\u1eb7c thi\u1ebft k\u1ebf\/ c\u00f4ng th\u1ee9c c\u1ee7a v\u1eadt li\u1ec7u ph\u1ee5 (v\u00ed d\u1ee5: theo th\u1ecfa thu\u1eadn ch\u1ea5t l\u01b0\u1ee3ng)<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><td class=\"has-text-align-center\" data-align=\"center\">&nbsp;<\/td><\/tr><tr><td>Chu\u1ea9n b\u1ecb v\u00e0 g\u1eedi m\u1ed9t file ch\u00ednh v\u1ec1 v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3, n\u1ebfu c\u00f3<\/td><td class=\"has-text-align-center\" data-align=\"center\">X<\/td><td class=\"has-text-align-center\" data-align=\"center\">&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>T\u00f3m l\u1ea1i, t\u00e0i li\u1ec7u n\u00e0y ch\u1ec9 cung c\u1ea5p t\u1ed5ng qu\u00e1t chung v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3. \u0110\u1ec3 th\u1ea3o lu\u1eadn s\u00e2u h\u01a1n v\u1ec1 c\u00e1c ch\u1ee7 \u0111\u1ec1 n\u00e0y, h\u00e3y tham kh\u1ea3o t\u00e0i li\u1ec7u Solomon v\u00e0 c\u1ed9ng s\u1ef1, xem x\u00e9t t\u00ecnh tr\u1ea1ng hi\u1ec7n t\u1ea1i c\u1ee7a quy \u0111\u1ecbnh v\u1ec1 v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 t\u1eeb g\u00f3c \u0111\u1ed9 to\u00e0n c\u1ea7u. Tuy nhi\u00ean, l\u01b0u \u00fd r\u1eb1ng \u0111i\u1ec1u quan tr\u1ecdng l\u00e0 c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t ph\u1ea3i t\u1ef1 l\u00e0m quen v\u1edbi d\u01b0\u1ee3c \u0111i\u1ec3n USP &lt;1043&gt; v\u00e0 c\u00e1c h\u01b0\u1edbng d\u1eabn hi\u1ec7n h\u00e0nh kh\u00e1c, t\u1ed1t h\u01a1n l\u00e0 tham gia tr\u1ef1c ti\u1ebfp v\u1edbi c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd \u1edf giai \u0111o\u1ea1n \u0111\u1ea7u c\u1ee7a qu\u00e1 tr\u00ecnh ph\u00e1t tri\u1ec3n s\u1ea3n ph\u1ea9m.<\/p>\n\n\n\n<p><strong>NGU\u1ed2N THAM KH\u1ea2O<\/strong><\/p>\n\n\n\n<p>Stemcell Technologies \u2013 Canada<\/p>\n\n\n\n<p>Solomon J et al. (2016) Current perspectives on the use of ancillary materials for the manufacture of cellular therapies. Cytotherapy 18(1): 1-12.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>V\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3 bao g\u1ed3m h\u00f3a ch\u1ea5t\/ m\u00f4i tr\u01b0\u1eddng ph\u00e2n l\u1eadp t\u1ebf b\u00e0o, m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y v\u00e0 m\u00f4i tr\u01b0\u1eddng b\u1ea3o qu\u1ea3n l\u1ea1nh t\u1ebf b\u00e0o, v\u00e0 v\u1eadt t\u01b0 ti\u00eau hao d\u00f9ng m\u1ed9t l\u1ea7n nh\u01b0 v\u1eadt t\u01b0 nh\u1ef1a v\u00e0 t\u00fai x\u1eed l\u00fd v\u00e0 l\u01b0u tr\u1eef t\u1ebf b\u00e0o. \u201cCh\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u ph\u1ee5 tr\u1ee3\u201d \u0111\u1ec1 c\u1eadp<\/p>\n<div class=\"klb-readmore post-buttons\"><a class=\"button rounded primary\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/chat-luong-vat-lieu-phu-tro-trong-san-xuat-tri-lieu-te-bao-bat-dau-tu-dau\/\">Read More <i 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