{"id":11267,"date":"2026-06-18T18:09:03","date_gmt":"2026-06-18T11:09:03","guid":{"rendered":"https:\/\/biogroupvietnam.com\/?p=11267"},"modified":"2026-06-19T09:13:23","modified_gmt":"2026-06-19T02:13:23","slug":"tiem-nang-evs-chuyen-doi-rd-sang-gmp-manufacturing","status":"publish","type":"post","link":"https:\/\/biogroupvietnam.com\/vi\/blog\/tiem-nang-evs-chuyen-doi-rd-sang-gmp-manufacturing\/","title":{"rendered":"Ti\u1ec1m n\u0103ng c\u1ee7a EVs v\u00e0 nh\u1eefng v\u1ea5n \u0111\u1ec1 trong chuy\u1ec3n \u0111\u1ed5i t\u1eeb R&amp;D sang l\u00e2m s\u00e0ng"},"content":{"rendered":"\n<p>Tr\u01b0\u1edbc ti\u1ec1m n\u0103ng sinh h\u1ecdc m\u1ea1nh m\u1ebd, ph\u1ea7n l\u1edbn \u0111\u01a1n v\u1ecb l\u00e0m v\u1ec1 li\u1ec7u ph\u00e1p EVs v\u1eabn \u0111ang v\u01b0\u1edbn \u1edf giai \u0111o\u1ea1n pre-clinical v\u00ec nh\u1eefng r\u00e0o c\u1ea3n k\u1ef9 thu\u1eadt quy m\u00f4 s\u1ea3n xu\u1ea5t s\u1ea3n xu\u1ea5t v\u00e0 giai \u0111o\u1ea1n tinh s\u1ea1ch. V\u1eady l\u00e0m sao s\u1ea3n xu\u1ea5t \u0111\u1ee7 EVs ch\u1ea5t l\u01b0\u1ee3ng \u1ed5n \u0111\u1ecbnh, tinh s\u1ea1ch cao \u0111\u1ec3 \u0111\u01b0a v\u00e0o clinical trial? T\u00ecm hi\u1ec3u 3 kho\u1ea3ng c\u00e1ch ch\u00ednh gi\u1eefa EVs trong research v\u00e0 GMP Manufacturing; c\u00e1ch c\u00e1c \u0111\u01a1n v\u1ecb \u0111ang tri\u1ec3n khai th\u1ef1c t\u1ebf li\u1ec7u ph\u00e1p EVs cho l\u00e2m s\u00e0ng trong b\u00e0i vi\u1ebft n\u00e0y.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/06\/tiem-nang-evs-nhung-van-de-trong-chuyen-doi-tu-r-d-sang-lam-sang-1024x576.png\" alt=\"\" class=\"wp-image-11268\" srcset=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/06\/tiem-nang-evs-nhung-van-de-trong-chuyen-doi-tu-r-d-sang-lam-sang-1024x576.png 1024w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/06\/tiem-nang-evs-nhung-van-de-trong-chuyen-doi-tu-r-d-sang-lam-sang-300x169.png 300w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/06\/tiem-nang-evs-nhung-van-de-trong-chuyen-doi-tu-r-d-sang-lam-sang-768x432.png 768w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/06\/tiem-nang-evs-nhung-van-de-trong-chuyen-doi-tu-r-d-sang-lam-sang-1536x864.png 1536w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/06\/tiem-nang-evs-nhung-van-de-trong-chuyen-doi-tu-r-d-sang-lam-sang-600x338.png 600w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/06\/tiem-nang-evs-nhung-van-de-trong-chuyen-doi-tu-r-d-sang-lam-sang-90x51.png 90w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2026\/06\/tiem-nang-evs-nhung-van-de-trong-chuyen-doi-tu-r-d-sang-lam-sang.png 1920w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_83 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\">M\u1ee5c l\u1ee5c<\/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\/vi\/blog\/tiem-nang-evs-chuyen-doi-rd-sang-gmp-manufacturing\/#EVs_dang_o_dau_trong_hanh_trinh_tu_phong_thi_nghiem_den_lam_sang\" >EVs \u0111ang \u1edf \u0111\u00e2u trong h\u00e0nh tr\u00ecnh t\u1eeb ph\u00f2ng th\u00ed nghi\u1ec7m \u0111\u1ebfn l\u00e2m s\u00e0ng?<\/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\/vi\/blog\/tiem-nang-evs-chuyen-doi-rd-sang-gmp-manufacturing\/#Ba_khoang_cach_chinh_giua_EVs_trong_research_va_GMP_Manufacturing\" >Ba kho\u1ea3ng c\u00e1ch ch\u00ednh gi\u1eefa EVs trong research v\u00e0 GMP Manufacturing<\/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\/vi\/blog\/tiem-nang-evs-chuyen-doi-rd-sang-gmp-manufacturing\/#1_Yield_reproducibility_hieu_suat_thu_hoi_va_do_tai_lap_giua_cac_me\" >1. Yield &amp; reproducibility: hi\u1ec7u su\u1ea5t thu h\u1ed3i v\u00e0 \u0111\u1ed9 t\u00e1i l\u1eadp gi\u1eefa c\u00e1c m\u1ebb<\/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\/vi\/blog\/tiem-nang-evs-chuyen-doi-rd-sang-gmp-manufacturing\/#2_Purity_do_tinh_sach_khong_chi_la_yeu_cau_ky_thuat_ma_la_dieu_kien_kiem_soat_chat_luong\" >2. Purity: \u0111\u1ed9 tinh s\u1ea1ch kh\u00f4ng ch\u1ec9 l\u00e0 y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt, m\u00e0 l\u00e0 \u0111i\u1ec1u ki\u1ec7n ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng<\/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\/vi\/blog\/tiem-nang-evs-chuyen-doi-rd-sang-gmp-manufacturing\/#3_Scalability_quy_trinh_1_mL_trong_lab_khong_the_tu_dong_tro_thanh_quy_trinh_100_mL_hoac_1_L\" >3. Scalability: quy tr\u00ecnh 1 mL trong lab kh\u00f4ng th\u1ec3 t\u1ef1 \u0111\u1ed9ng tr\u1edf th\u00e0nh quy tr\u00ecnh 100 mL ho\u1eb7c 1 L<\/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\/vi\/blog\/tiem-nang-evs-chuyen-doi-rd-sang-gmp-manufacturing\/#Cac_don_vi_tiep_can_thanh_cong_bai_toan_san_xuat_EVs_co_dac_diem_gi\" >C\u00e1c \u0111\u01a1n v\u1ecb ti\u1ebfp c\u1eadn th\u00e0nh c\u00f4ng b\u00e0i to\u00e1n s\u1ea3n xu\u1ea5t EVs c\u00f3 \u0111\u1eb7c \u0111i\u1ec3m g\u00ec?<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"EVs_dang_o_dau_trong_hanh_trinh_tu_phong_thi_nghiem_den_lam_sang\"><\/span><strong>EVs \u0111ang \u1edf \u0111\u00e2u trong h\u00e0nh tr\u00ecnh t\u1eeb ph\u00f2ng th\u00ed nghi\u1ec7m \u0111\u1ebfn l\u00e2m s\u00e0ng?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Extracellular vesicles, th\u01b0\u1eddng \u0111\u01b0\u1ee3c g\u1ecdi t\u1eaft l\u00e0 EVs, \u0111ang l\u00e0 m\u1ed9t trong nh\u1eefng h\u01b0\u1edbng nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c quan t\u00e2m trong l\u0129nh v\u1ef1c li\u1ec7u ph\u00e1p sinh h\u1ecdc v\u00e0 y h\u1ecdc t\u00e1i t\u1ea1o. V\u1edbi kh\u1ea3 n\u0103ng mang theo protein, lipid, RNA v\u00e0 nhi\u1ec1u t\u00edn hi\u1ec7u sinh h\u1ecdc t\u1eeb t\u1ebf b\u00e0o ngu\u1ed3n, EVs \u0111\u01b0\u1ee3c k\u1ef3 v\u1ecdng c\u00f3 th\u1ec3 \u0111\u00f3ng vai tr\u00f2 quan tr\u1ecdng trong c\u00e1c \u1ee9ng d\u1ee5ng ch\u1ea9n \u0111o\u00e1n, nghi\u00ean c\u1ee9u b\u1ec7nh h\u1ecdc v\u00e0 ph\u00e1t tri\u1ec3n s\u1ea3n ph\u1ea9m \u0111i\u1ec1u tr\u1ecb trong t\u01b0\u01a1ng lai.<\/p>\n\n\n\n<p>T\u00ednh \u0111\u1ebfn th\u00e1ng 5\/2025, h\u01a1n 200 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng li\u00ean quan \u0111\u1ebfn EVs \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd tr\u00ean ClinicalTrials.gov. C\u00f9ng v\u1edbi \u0111\u00f3, th\u1ecb tr\u01b0\u1eddng exosome therapeutics to\u00e0n c\u1ea7u \u0111\u01b0\u1ee3c d\u1ef1 b\u00e1o ti\u1ebfp t\u1ee5c t\u0103ng tr\u01b0\u1edfng m\u1ea1nh trong giai \u0111o\u1ea1n t\u1edbi, ph\u1ea3n \u00e1nh m\u1ee9c \u0111\u1ed9 quan t\u00e2m ng\u00e0y c\u00e0ng l\u1edbn c\u1ee7a ng\u00e0nh life science \u0111\u1ed1i v\u1edbi nh\u00f3m s\u1ea3n ph\u1ea9m n\u00e0y.<\/p>\n\n\n\n<p>Tuy nhi\u00ean, gi\u1eefa \u201cti\u1ec1m n\u0103ng sinh h\u1ecdc\u201d v\u00e0 \u201cs\u1ea3n ph\u1ea9m c\u00f3 th\u1ec3 \u0111i v\u00e0o clinical trial\u201d v\u1eabn t\u1ed3n t\u1ea1i m\u1ed9t kho\u1ea3ng c\u00e1ch r\u1ea5t l\u1edbn. Ph\u1ea7n l\u1edbn \u0111\u01a1n v\u1ecb hi\u1ec7n v\u1eabn \u0111ang d\u1eebng \u1edf giai \u0111o\u1ea1n pre-clinical, kh\u00f4ng ph\u1ea3i v\u00ec EVs thi\u1ebfu ti\u1ec1m n\u0103ng, m\u00e0 v\u00ec quy tr\u00ecnh s\u1ea3n xu\u1ea5t, tinh s\u1ea1ch v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng ch\u01b0a \u0111\u1ee7 \u1ed5n \u0111\u1ecbnh \u0111\u1ec3 \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u c\u1ee7a giai \u0111o\u1ea1n l\u00e2m s\u00e0ng.<\/p>\n\n\n\n<p>Trong giai \u0111o\u1ea1n nghi\u00ean c\u1ee9u, nhi\u1ec1u nh\u00f3m th\u01b0\u1eddng t\u1eadp trung v\u00e0o vi\u1ec7c t\u00e1ch exosome, \u0111o k\u00edch th\u01b0\u1edbc h\u1ea1t, ph\u00e2n t\u00edch marker ho\u1eb7c characterization c\u01a1 b\u1ea3n. \u0110\u00e2y l\u00e0 nh\u1eefng b\u01b0\u1edbc c\u1ea7n thi\u1ebft, nh\u01b0ng ch\u01b0a \u0111\u1ee7 \u0111\u1ec3 t\u1ea1o ra m\u1ed9t s\u1ea3n ph\u1ea9m EVs c\u00f3 ch\u1ea5t l\u01b0\u1ee3ng \u1ed5n \u0111\u1ecbnh, tinh s\u1ea1ch cao v\u00e0 c\u00f3 kh\u1ea3 n\u0103ng m\u1edf r\u1ed9ng quy m\u00f4.<\/p>\n\n\n\n<p>\u0110\u1ec3 ti\u1ebfn g\u1ea7n h\u01a1n \u0111\u1ebfn clinical trial, quy tr\u00ecnh EVs c\u1ea7n \u0111\u01b0\u1ee3c nh\u00ecn nh\u01b0 m\u1ed9t workflow ho\u00e0n ch\u1ec9nh, trong \u0111\u00f3 t\u1eebng b\u01b0\u1edbc \u0111\u1ec1u \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng th\u00e0nh ph\u1ea9m cu\u1ed1i c\u00f9ng:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Cell source<\/li>\n\n\n\n<li>Expansion platform<\/li>\n\n\n\n<li>Culture medium<\/li>\n\n\n\n<li>Harvest strategy<\/li>\n\n\n\n<li>Purification<\/li>\n\n\n\n<li>QC<\/li>\n\n\n\n<li>Fill &amp; Finish<\/li>\n\n\n\n<li>Storage<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ba_khoang_cach_chinh_giua_EVs_trong_research_va_GMP_Manufacturing\"><\/span><strong>Ba kho\u1ea3ng c\u00e1ch ch\u00ednh gi\u1eefa EVs trong research v\u00e0 GMP Manufacturing<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1_Yield_reproducibility_hieu_suat_thu_hoi_va_do_tai_lap_giua_cac_me\"><\/span>1. Yield &amp; reproducibility: hi\u1ec7u su\u1ea5t thu h\u1ed3i v\u00e0 \u0111\u1ed9 t\u00e1i l\u1eadp gi\u1eefa c\u00e1c m\u1ebb<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Trong nhi\u1ec1u ph\u00f2ng th\u00ed nghi\u1ec7m, si\u00eau ly t\u00e2m truy\u1ec1n th\u1ed1ng v\u1eabn l\u00e0 ph\u01b0\u01a1ng ph\u00e1p \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng ph\u1ed5 bi\u1ebfn \u0111\u1ec3 ph\u00e2n l\u1eadp EVs. Tuy nhi\u00ean, ph\u01b0\u01a1ng ph\u00e1p n\u00e0y th\u01b0\u1eddng t\u1ed1n th\u1eddi gian, ph\u1ee5 thu\u1ed9c nhi\u1ec1u v\u00e0o \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh v\u00e0 c\u00f3 th\u1ec3 t\u1ea1o ra bi\u1ebfn \u0111\u1ed9ng \u0111\u00e1ng k\u1ec3 gi\u1eefa c\u00e1c m\u1ebb.<\/p>\n\n\n\n<p>Ph\u00e2n l\u1eadp b\u1eb1ng si\u00eau ly t\u00e2m (UC) truy\u1ec1n th\u1ed1ng cho hi\u1ec7u su\u1ea5t thu h\u1ed3i th\u1ea5p, t\u1ed1n th\u1eddi gian (4\u20136h\/m\u1eabu), v\u00e0 bi\u1ebfn \u0111\u1ed9ng theo m\u1ebb r\u1ea5t cao &#8211; kh\u00f4ng th\u1ec3 ki\u1ec3m so\u00e1t trong m\u00f4i tr\u01b0\u1eddng GMP. Trong m\u00f4i tr\u01b0\u1eddng GMP Manufacturing, n\u01a1i m\u1ed7i m\u1ebb s\u1ea3n xu\u1ea5t c\u1ea7n \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t, ghi nh\u1eadn v\u00e0 t\u00e1i l\u1eadp, yield kh\u00f4ng \u1ed5n \u0111\u1ecbnh l\u00e0 m\u1ed9t r\u00e0o c\u1ea3n l\u1edbn.<\/p>\n\n\n\n<p>M\u1ed9t quy tr\u00ecnh EVs ph\u00f9 h\u1ee3p cho clinical trial c\u1ea7n ch\u1ee9ng minh \u0111\u01b0\u1ee3c kh\u1ea3 n\u0103ng t\u1ea1o ra s\u1ea3n l\u01b0\u1ee3ng \u0111\u1ee7 l\u1edbn, \u0111\u1ed3ng th\u1eddi duy tr\u00ec ch\u1ea5t l\u01b0\u1ee3ng \u1ed5n \u0111\u1ecbnh qua nhi\u1ec1u l\u1ea7n s\u1ea3n xu\u1ea5t.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2_Purity_do_tinh_sach_khong_chi_la_yeu_cau_ky_thuat_ma_la_dieu_kien_kiem_soat_chat_luong\"><\/span>2. Purity: \u0111\u1ed9 tinh s\u1ea1ch kh\u00f4ng ch\u1ec9 l\u00e0 y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt, m\u00e0 l\u00e0 \u0111i\u1ec1u ki\u1ec7n ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>H\u1ea7u h\u1ebft ph\u01b0\u01a1ng ph\u00e1p tinh s\u1ea1ch \u0111\u1ec1u ch\u01b0a lo\u1ea1i \u0111\u01b0\u1ee3c h\u1ebft t\u1ea1p ch\u1ea5t (protein, lipoprotein, aggregates). M\u1ed9t m\u1eabu EVs &#8220;\u0111\u1ee7 t\u1ed1t cho nghi\u00ean c\u1ee9u&#8221; ho\u00e0n to\u00e0n c\u00f3 th\u1ec3 b\u1ecb t\u1eeb ch\u1ed1i trong giai \u0111o\u1ea1n ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a GMP lab.<\/p>\n\n\n\n<p>Nh\u1eefng t\u1ea1p ch\u1ea5t n\u00e0y c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn k\u1ebft qu\u1ea3 characterization, \u0111\u1ed9 an to\u00e0n, \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh v\u00e0 kh\u1ea3 n\u0103ng \u0111\u00e1nh gi\u00e1 s\u1ea3n ph\u1ea9m. V\u00ec v\u1eady, purity c\u1ea7n \u0111\u01b0\u1ee3c xem l\u00e0 m\u1ed9t ti\u00eau ch\u00ed trung t\u00e2m trong thi\u1ebft k\u1ebf downstream workflow, kh\u00f4ng ph\u1ea3i l\u00e0 b\u01b0\u1edbc ki\u1ec3m tra sau c\u00f9ng.<\/p>\n\n\n\n<p>\u0110\u1ed1i v\u1edbi EVs h\u01b0\u1edbng \u0111\u1ebfn l\u00e2m s\u00e0ng, tinh s\u1ea1ch gi\u00fap quy tr\u00ecnh tr\u1edf n\u00ean d\u1ec5 ki\u1ec3m so\u00e1t h\u01a1n, minh b\u1ea1ch h\u01a1n v\u00e0 ph\u00f9 h\u1ee3p h\u01a1n v\u1edbi y\u00eau c\u1ea7u ph\u00e1t tri\u1ec3n s\u1ea3n ph\u1ea9m.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"3_Scalability_quy_trinh_1_mL_trong_lab_khong_the_tu_dong_tro_thanh_quy_trinh_100_mL_hoac_1_L\"><\/span>3. Scalability: quy tr\u00ecnh 1 mL trong lab kh\u00f4ng th\u1ec3 t\u1ef1 \u0111\u1ed9ng tr\u1edf th\u00e0nh quy tr\u00ecnh 100 mL ho\u1eb7c 1 L<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>M\u1ed9t trong nh\u1eefng nh\u1ea7m l\u1eabn ph\u1ed5 bi\u1ebfn khi ph\u00e1t tri\u1ec3n EVs l\u00e0 cho r\u1eb1ng quy tr\u00ecnh \u0111\u00e3 ho\u1ea1t \u0111\u1ed9ng t\u1ed1t \u1edf quy m\u00f4 nh\u1ecf c\u00f3 th\u1ec3 scale-up tuy\u1ebfn t\u00ednh. Tr\u00ean th\u1ef1c t\u1ebf, quy tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng \u1edf 1 mL \u0111i\u1ec1u ki\u1ec7n lab g\u1ea7n nh\u01b0 kh\u00f4ng bao gi\u1edd scale tuy\u1ebfn t\u00ednh l\u00ean 100 mL hay 1 L m\u00e0 kh\u00f4ng c\u1ea7n thi\u1ebft k\u1ebf l\u1ea1i to\u00e0n b\u1ed9 downstream workflow.<\/p>\n\n\n\n<p>C\u00e1c y\u1ebfu t\u1ed1 nh\u01b0 th\u1eddi gian x\u1eed l\u00fd, t\u1ea3i l\u01b0\u1ee3ng m\u00e0ng l\u1ecdc, nguy c\u01a1 t\u1eafc ngh\u1ebdn, hi\u1ec7u su\u1ea5t thu h\u1ed3i, \u0111\u1ed9 pha lo\u00e3ng, kh\u1ea3 n\u0103ng lo\u1ea1i b\u1ecf t\u1ea1p ch\u1ea5t v\u00e0 \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh \u0111\u1ec1u thay \u0111\u1ed5i khi th\u1ec3 t\u00edch t\u0103ng l\u00ean.<\/p>\n\n\n\n<p>V\u00ec v\u1eady, scalability kh\u00f4ng ch\u1ec9 l\u00e0 ch\u1ea1y m\u1eabu l\u1edbn h\u01a1n. \u0110\u00e2y l\u00e0 b\u00e0i to\u00e1n thi\u1ebft k\u1ebf quy tr\u00ecnh, trong \u0111\u00f3 upstream, harvest, purification, QC, fill &amp; finish v\u00e0 storage c\u1ea7n \u0111\u01b0\u1ee3c li\u00ean k\u1ebft th\u00e0nh m\u1ed9t h\u1ec7 th\u1ed1ng c\u00f3 th\u1ec3 ki\u1ec3m so\u00e1t.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Cac_don_vi_tiep_can_thanh_cong_bai_toan_san_xuat_EVs_co_dac_diem_gi\"><\/span><strong>C\u00e1c \u0111\u01a1n v\u1ecb ti\u1ebfp c\u1eadn th\u00e0nh c\u00f4ng b\u00e0i to\u00e1n s\u1ea3n xu\u1ea5t EVs c\u00f3 \u0111\u1eb7c \u0111i\u1ec3m g\u00ec?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u0110\u1ec3 v\u01b0\u1ee3t qua gi\u1edbi h\u1ea1n c\u1ee7a si\u00eau ly t\u00e2m truy\u1ec1n th\u1ed1ng, nhi\u1ec1u \u0111\u01a1n v\u1ecb \u0111ang chuy\u1ec3n sang c\u00e1c h\u1ec7 th\u1ed1ng t\u1ef1 \u0111\u1ed9ng h\u00f3a v\u00e0 c\u00f4ng ngh\u1ec7 downstream c\u00f3 kh\u1ea3 n\u0103ng x\u1eed l\u00fd th\u1ec3 t\u00edch l\u1edbn h\u01a1n, ki\u1ec3m so\u00e1t t\u1ed1t h\u01a1n v\u00e0 ph\u00f9 h\u1ee3p h\u01a1n v\u1edbi \u0111\u1ecbnh h\u01b0\u1edbng GMP.<\/p>\n\n\n\n<p>Thay th\u1ebf si\u00eau ly t\u00e2m (UC) b\u1eb1ng c\u00e1c h\u1ec7 th\u1ed1ng t\u1ef1 \u0111\u1ed9ng h\u00f3a d\u1ef1a tr\u00ean:<\/p>\n\n\n\n<p>&nbsp; \u2192 Size-exclusion chromatography (SEC) t\u00edch h\u1ee3p v\u1edbi TFF<\/p>\n\n\n\n<p>&nbsp; \u2192 Tangential Flow Filtration (TFF) cho volume l\u1edbn<\/p>\n\n\n\n<p>&nbsp; \u2192 Acoustic membrane vibration + negative pressure oscillation<\/p>\n\n\n\n<p>Trong \u0111\u00f3, m\u1ed9t b\u01b0\u1edbc \u0111\u1ed9t ph\u00e1 \u0111\u00e1ng ch\u00fa \u00fd \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 tr\u00ean Nature Methods (Chen et al., 2021) l\u00e0 h\u1ec7 th\u1ed1ng EXODUS s\u1eed d\u1ee5ng c\u01a1 ch\u1ebf dao \u0111\u1ed9ng m\u00e0ng k\u00e9p k\u1ebft h\u1ee3p \u00e1p su\u1ea5t \u00e2m (negative pressure oscillation + double coupled harmonic oscillation) \u0111\u1ec3 t\u1ea1o ra s\u00f3ng ngang tr\u00ean m\u00e0ng l\u1ecdc nano.<\/p>\n\n\n\n<p>Theo c\u00f4ng b\u1ed1 c\u1ee7a Chen v\u00e0 c\u1ed9ng s\u1ef1, EXODUS cho th\u1ea5y \u01b0u th\u1ebf so v\u1edbi nhi\u1ec1u ph\u01b0\u01a1ng ph\u00e1p hi\u1ec7n c\u00f3 tr\u00ean ba ti\u00eau ch\u00ed quan tr\u1ecdng:<\/p>\n\n\n\n<p>&nbsp; \u2713 Speed (ph\u00e2n l\u1eadp nhanh ch\u00f3ng)<\/p>\n\n\n\n<p>&nbsp; \u2713 Purity (lo\u1ea1i b\u1ecf protein t\u1ea1p t\u1ef1 do, nucleic acid t\u1ea1p ch\u1ea5t)<\/p>\n\n\n\n<p>&nbsp; \u2713 Yield (hi\u1ec7u su\u1ea5t thu h\u1ed3i cao h\u01a1n \u0111\u00e1ng k\u1ec3)<\/p>\n\n\n\n<p>\u0110\u00e2y l\u00e0 nh\u1eefng y\u1ebfu t\u1ed1 c\u00f3 \u00fd ngh\u0129a tr\u1ef1c ti\u1ebfp khi c\u00e1c \u0111\u01a1n v\u1ecb mu\u1ed1n ti\u1ebfn t\u1eeb nghi\u00ean c\u1ee9u EVs sang quy tr\u00ecnh c\u00f3 kh\u1ea3 n\u0103ng chu\u1ea9n h\u00f3a v\u00e0 m\u1edf r\u1ed9ng h\u01a1n.<\/p>\n\n\n\n<p>Biogroup trong vai tr\u00f2 \u0111\u1ed1i t\u00e1c ph\u00e2n ph\u1ed1i v\u00e0 chuy\u1ec3n giao c\u00f4ng ngh\u1ec7, \u0111ang \u0111\u01b0a h\u1ec7 th\u1ed1ng EXODUS v\u00e0o Vi\u1ec7t Nam. V\u1edbi kinh nghi\u1ec7m t\u01b0 v\u1ea5n v\u00e0 k\u1ebft h\u1ee3p c\u00f4ng ngh\u1ec7, ch\u00fang t\u00f4i kh\u00f4ng ch\u1ec9 cung c\u1ea5p thi\u1ebft b\u1ecb, m\u00e0 l\u00e0 to\u00e0n b\u1ed9 end-to-end EVs workflow: t\u1eeb nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o, ph\u00e2n l\u1eadp, tinh s\u1ea1ch downstream, \u0111\u1ebfn t\u1ea1o th\u00e0nh ph\u1ea9m \u0111\u00f4ng kh\u00f4 s\u1eb5n s\u00e0ng th\u01b0\u01a1ng m\u1ea1i h\u00f3a.<\/p>\n\n\n\n<p><strong>Xem th\u00eam<\/strong><a href=\"https:\/\/biogroupvietnam.com\/vi\/giai-phap\/giai-phap-san-xuat-va-chuyen-giao-quy-trinh-evs\/\"> Gi\u1ea3i ph\u00e1p s\u1ea3n xu\u1ea5t v\u00e0 chuy\u1ec3n giao quy tr\u00ecnh EVs<\/a><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>NGU\u1ed2N THAM KH\u1ea2O<\/strong><\/p>\n\n\n\n<p>U.S. National Library of Medicine. <em>ClinicalTrials.gov<\/em>. \u201cSearch results for extracellular vesicles \/ exosomes clinical trials.\u201d <a href=\"https:\/\/clinicaltrials.gov\/\">https:\/\/clinicaltrials.gov\/<\/a><\/p>\n\n\n\n<p>Precedence Research. <em>Precedence Research<\/em>. \u201cExosome Therapy Market Size to Hit USD 307.04 Billion by 2035.\u201d <a href=\"https:\/\/www.precedenceresearch.com\/exosome-therapy-market\">https:\/\/www.precedenceresearch.com\/exosome-therapy-market<\/a><\/p>\n\n\n\n<p>Welsh, J. A., et al. <em>Journal of Extracellular Vesicles<\/em>. \u201cMinimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches.\u201d <a href=\"https:\/\/isevjournals.onlinelibrary.wiley.com\/doi\/10.1002\/jev2.12404\">https:\/\/isevjournals.onlinelibrary.wiley.com\/doi\/10.1002\/jev2.12404<\/a><\/p>\n\n\n\n<p>International Society for Extracellular Vesicles (ISEV).<em> ISEV<\/em>. \u201cPosition Papers and Guidelines.\u201d <a href=\"https:\/\/www.isev.org\/position-papers-and-guidelines\">https:\/\/www.isev.org\/position-papers-and-guidelines<\/a><\/p>\n\n\n\n<p>Chen, Y., et al. <em>Nature Methods.<\/em> \u201cExosome detection via the ultrafast-isolation system: EXODUS.\u201d <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33432243\/\">https:\/\/pubmed.ncbi.nlm.nih.gov\/33432243\/<\/a><\/p>\n\n\n\n<p>Springer Nature Experiments. <em>Springer Nature Experiments.<\/em> \u201cExosome detection via the ultrafast-isolation system: EXODUS.\u201d <a href=\"https:\/\/experiments.springernature.com\/articles\/10.1038\/s41592-020-01034-x\">https:\/\/experiments.springernature.com\/articles\/10.1038\/s41592-020-01034-x<\/a><\/p>\n\n\n\n<p>ATA Scientific. <em>ATA Scientific.<\/em> \u201cEXODUS Brochure.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Tr\u01b0\u1edbc ti\u1ec1m n\u0103ng sinh h\u1ecdc m\u1ea1nh m\u1ebd, ph\u1ea7n l\u1edbn \u0111\u01a1n v\u1ecb l\u00e0m v\u1ec1 li\u1ec7u ph\u00e1p EVs v\u1eabn \u0111ang v\u01b0\u1edbn \u1edf giai \u0111o\u1ea1n pre-clinical v\u00ec nh\u1eefng r\u00e0o c\u1ea3n k\u1ef9 thu\u1eadt quy m\u00f4 s\u1ea3n xu\u1ea5t s\u1ea3n xu\u1ea5t v\u00e0 giai \u0111o\u1ea1n tinh s\u1ea1ch. V\u1eady l\u00e0m sao s\u1ea3n xu\u1ea5t \u0111\u1ee7 EVs ch\u1ea5t l\u01b0\u1ee3ng \u1ed5n \u0111\u1ecbnh, tinh s\u1ea1ch cao \u0111\u1ec3<\/p>\n<div class=\"klb-readmore post-buttons\"><a class=\"button rounded primary\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/tiem-nang-evs-chuyen-doi-rd-sang-gmp-manufacturing\/\">Read More <i class=\"klbth-icon-right-arrow\"><\/i><\/a><\/div>\n","protected":false},"author":1,"featured_media":11270,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-11267","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Ti\u1ec1m n\u0103ng c\u1ee7a EVs v\u00e0 nh\u1eefng v\u1ea5n \u0111\u1ec1 trong chuy\u1ec3n \u0111\u1ed5i t\u1eeb R&amp;D sang l\u00e2m s\u00e0ng<\/title>\n<meta name=\"description\" content=\"EVs\/ exosome \u0111ang m\u1edf ra nhi\u1ec1u ti\u1ec1m n\u0103ng trong nghi\u00ean c\u1ee9u v\u00e0 ph\u00e1t tri\u1ec3n li\u1ec7u ph\u00e1p m\u1edbi. Tuy nhi\u00ean, chuy\u1ec3n t\u1eeb R&amp;D sang s\u1ea3n xu\u1ea5t GMP \u0111\u00f2i h\u1ecfi ki\u1ec3m so\u00e1t yield, purity, scalability v\u00e0 to\u00e0n b\u1ed9 workflow downstream.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/tiem-nang-evs-chuyen-doi-rd-sang-gmp-manufacturing\/\" \/>\n<meta property=\"og:locale\" content=\"vi_VN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Ti\u1ec1m n\u0103ng c\u1ee7a EVs v\u00e0 nh\u1eefng v\u1ea5n \u0111\u1ec1 trong chuy\u1ec3n \u0111\u1ed5i t\u1eeb R&amp;D sang l\u00e2m s\u00e0ng\" \/>\n<meta property=\"og:description\" content=\"EVs\/ exosome \u0111ang m\u1edf ra nhi\u1ec1u ti\u1ec1m n\u0103ng trong nghi\u00ean c\u1ee9u v\u00e0 ph\u00e1t tri\u1ec3n li\u1ec7u ph\u00e1p m\u1edbi. 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