{"id":4233,"date":"2024-02-25T10:23:17","date_gmt":"2024-02-25T10:23:17","guid":{"rendered":"http:\/\/biogroupvietnam-worldpress.local\/2025\/08\/18\/what-does-it-mean-for-cell-culture-media-to-be-gmp-gradegmp-compliant\/"},"modified":"2025-12-03T11:55:01","modified_gmt":"2025-12-03T04:55:01","slug":"moi-truong-nuoi-cay-te-bao-dat-tieu-chuan-gmp-co-y-nghia-gi","status":"publish","type":"post","link":"https:\/\/biogroupvietnam.com\/vi\/dao-tao-webinar\/moi-truong-nuoi-cay-te-bao-dat-tieu-chuan-gmp-co-y-nghia-gi\/","title":{"rendered":"M\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o \u0111\u1ea1t ti\u00eau chu\u1ea9n GMP c\u00f3 \u00fd ngh\u0129a g\u00ec?"},"content":{"rendered":"

Khi \u0111\u1ec1 c\u1eadp \u0111\u1ebfn m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o \u201c\u0111\u1ea1t ti\u00eau chu\u1ea9n GMP<\/strong>\u201d ho\u1eb7c \u201ctu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n GMP<\/strong>\u201d, \u0111i\u1ec1u \u0111\u00f3 c\u00f3 ngh\u0129a l\u00e0 m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m so\u00e1t theo c\u00e1c nguy\u00ean t\u1eafc Th\u1ef1c h\u00e0nh S\u1ea3n xu\u1ea5t T\u1ed1t (Good Manufacturing Practices – GMP). GMP l\u00e0 m\u1ed9t b\u1ed9 h\u01b0\u1edbng d\u1eabn v\u00e0 th\u1ef1c h\u00e0nh \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng nh\u1eb1m cam k\u1ebft s\u1ea3n xu\u1ea5t nh\u1ea5t qu\u00e1n c\u00e1c s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m v\u00e0 t\u00e1 d\u01b0\u1ee3c (excipients) ch\u1ea5t l\u01b0\u1ee3ng cao \u0111\u1ed3ng th\u1eddi gi\u1ea3m thi\u1ec3u r\u1ee7i ro li\u00ean quan \u0111\u1ebfn nhi\u1ec5m m\u1eabu, sai s\u00f3t v\u00e0 \u0111\u1ed9 l\u1ec7ch.<\/p>\n

Vi\u1ec7c tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n GMP bao g\u1ed3m vi\u1ec7c tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n v\u00e0 th\u1ef1c h\u00e0nh nh\u1ea5t \u0111\u1ecbnh trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t, th\u1eed nghi\u1ec7m v\u00e0 qu\u00e1 tr\u00ecnh ph\u00e2n ph\u1ed1i. \u0110i\u1ec1u n\u00e0y \u0111\u1ea3m b\u1ea3o r\u1eb1ng m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o c\u00f3 ch\u1ea5t l\u01b0\u1ee3ng \u0111\u00e1ng tin c\u1eady, an to\u00e0n khi s\u1eed d\u1ee5ng v\u00e0 ph\u00f9 h\u1ee3p v\u1edbi m\u1ee5c \u0111\u00edch d\u1ef1 \u0111\u1ecbnh c\u1ee7a ch\u00fang, h\u1ed7 tr\u1ee3 s\u1ef1 ph\u00e1t tri\u1ec3n v\u00e0 duy tr\u00ec t\u1ebf b\u00e0o trong ph\u00f2ng th\u00ed nghi\u1ec7m ho\u1eb7c m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t.<\/p>\n

M\u1ed9t s\u1ed1 kh\u00eda c\u1ea1nh ch\u00ednh c\u1ee7a vi\u1ec7c tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n GMP \u0111\u1ed1i v\u1edbi m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o bao g\u1ed3m c\u00e1c b\u01b0\u1edbc quy tr\u00ecnh kh\u00e1c nhau, b\u1eaft \u0111\u1ea7u t\u1eeb ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 th\u1eed nghi\u1ec7m \u0111\u1ebfn l\u1eadp h\u1ed3 s\u01a1 v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c, \u0111\u1ebfn c\u00e1c kh\u00e1i ni\u1ec7m r\u1ed9ng h\u01a1n nh\u01b0 x\u00e1c nh\u1eadn, ch\u1ee9ng nh\u1eadn, \u0111\u00e0o t\u1ea1o, v\u1ec7 sinh v\u00e0 ti\u00eau chu\u1ea9n c\u01a1 s\u1edf. V\u00ed d\u1ee5, vi\u1ec7c ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n GMP bao g\u1ed3m c\u00e1c ki\u1ec3m tra nghi\u00eam ng\u1eb7t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u00fang \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng \u0111\u00e3 ch\u1ec9 \u0111\u1ecbnh. \u0110i\u1ec1u n\u00e0y bao g\u1ed3m c\u00e1c x\u00e9t nghi\u1ec7m v\u1ec1 nhi\u1ec5m vi sinh v\u1eadt, n\u1ed3ng \u0111\u1ed9 n\u1ed9i \u0111\u1ed9c t\u1ed1, \u0111\u1ed9 pH, \u0111\u1ed9 th\u1ea9m th\u1ea5u v\u00e0 h\u00e0m l\u01b0\u1ee3ng dinh d\u01b0\u1ee1ng, c\u00f9ng nhi\u1ec1u x\u00e9t nghi\u1ec7m kh\u00e1c. \u201cTi\u00eau chu\u1ea9n v\u00e0ng\u201d cho c\u00e1c ph\u01b0\u01a1ng ph\u00e1p th\u1eed nghi\u1ec7m \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 trong D\u01b0\u1ee3c \u0111i\u1ec3n Ch\u00e2u \u00c2u, \u0111\u00e2y l\u00e0 ti\u00eau chu\u1ea9n b\u1eaft bu\u1ed9c \u0111\u1ed1i v\u1edbi d\u01b0\u1ee3c ph\u1ea9m, nh\u01b0ng kh\u00f4ng b\u1eaft bu\u1ed9c \u0111\u1ed1i v\u1edbi m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o.<\/p>\n

Kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c v\u00e0 t\u00e0i li\u1ec7u r\u00f5 r\u00e0ng \u0111\u01b0\u1ee3c h\u01b0\u1edfng l\u1ee3i t\u1eeb vi\u1ec7c \u00e1p d\u1ee5ng ti\u00eau chu\u1ea9n GMP. C\u00e1c th\u00e0nh ph\u1ea7n v\u00e0 v\u1eadt li\u1ec7u \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 t\u1ea1o n\u00ean m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o ph\u1ea3i \u0111\u01b0\u1ee3c truy xu\u1ea5t ngu\u1ed3n g\u1ed1c ban \u0111\u1ea7u c\u1ee7a ch\u00fang. \u0110i\u1ec1u n\u00e0y gi\u00fap \u0111\u1ea3m b\u1ea3o t\u00ednh nh\u1ea5t qu\u00e1n v\u00e0 tr\u00e1ch nhi\u1ec7m gi\u1ea3i tr\u00ecnh trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t. T\u00e0i li\u1ec7u to\u00e0n di\u1ec7n v\u1ec1 quy tr\u00ecnh s\u1ea3n xu\u1ea5t, quy tr\u00ecnh ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m l\u00e0 \u0111i\u1ec1u c\u1ea7n thi\u1ebft \u0111\u1ec3 ch\u1ee9ng minh s\u1ef1 tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n GMP v\u00e0 t\u1ea1o \u0111i\u1ec1u ki\u1ec7n thu\u1eadn l\u1ee3i cho vi\u1ec7c thanh tra ho\u1eb7c ki\u1ec3m to\u00e1n theo quy \u0111\u1ecbnh t\u1eeb c\u00e1c b\u00ean b\u00ean ngo\u00e0i.<\/p>\n

M\u1ed9t nh\u00e2n t\u1ed1 l\u1edbn kh\u00e1c \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn vi\u1ec7c s\u1ea3n xu\u1ea5t m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o cho ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m l\u00e0 th\u1ef1c hi\u1ec7n quy tr\u00ecnh x\u00e1c nh\u1eadn v\u00e0 th\u1ea9m \u0111\u1ecbnh. Quy tr\u00ecnh s\u1ea3n xu\u1ea5t ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn v\u1ec1 ph\u01b0\u01a1ng ph\u00e1p v\u00e0 \u0111\u1ed9 tin c\u1eady c\u1ee7a ch\u00fang. Thi\u1ebft b\u1ecb ph\u1ea3i \u0111\u1ee7 ti\u00eau chu\u1ea9n \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u00fang t\u1ea1o ra m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o m\u1ed9t c\u00e1ch nh\u1ea5t qu\u00e1n, \u0111\u00e1p \u1ee9ng c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt \u0111\u00e3 x\u00e1c \u0111\u1ecbnh tr\u01b0\u1edbc.<\/p>\n

M\u1ed9t ph\u1ea7n quan tr\u1ecdng c\u1ee7a m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n GMP l\u00e0 nh\u00e2n s\u1ef1 v\u00e0 c\u00e1c quy tr\u00ecnh \u0111\u00e0o t\u1ea1o nh\u00e2n s\u1ef1 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n v\u00ec nh\u00e2n vi\u00ean tham gia s\u1ea3n xu\u1ea5t m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o \u0111\u1ea1t ti\u00eau chu\u1ea9n GMP c\u1ea7n \u0111\u01b0\u1ee3c \u0111\u00e0o t\u1ea1o \u0111\u1ea7y \u0111\u1ee7 v\u1ec1 c\u00e1c nguy\u00ean t\u1eafc v\u00e0 th\u1ef1c h\u00e0nh GMP, v\u00e0 v\u00ec h\u1ecd ph\u1ea3i tu\u00e2n th\u1ee7 nghi\u00eam ng\u1eb7t nh\u1eefng nguy\u00ean t\u1eafc v\u00e0 th\u1ef1c h\u00e0nh n\u00e0y. Tuy nhi\u00ean, cu\u1ed1i c\u00f9ng, c\u00e1c quy \u0111\u1ecbnh tu\u00e2n th\u1ee7 t\u1ed1t nh\u1ea5t s\u1ebd v\u00f4 \u00edch n\u1ebfu nh\u00e2n vi\u00ean kh\u00f4ng hi\u1ec3u ch\u00fang ho\u1eb7c kh\u00f4ng quen v\u1edbi vi\u1ec7c \u00e1p d\u1ee5ng ch\u00fang. Nh\u00e2n vi\u00ean \u0111\u00f3ng g\u00f3p vai tr\u00f2 l\u1edbn trong m\u1ed9t m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t tu\u00e2n th\u1ee7.<\/p>\n

T\u00f3m l\u1ea1i, khi m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o \u0111\u01b0\u1ee3c d\u00e1n nh\u00e3n l\u00e0 \u0111\u1ea1t ti\u00eau chu\u1ea9n GMP ho\u1eb7c tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n GMP, \u0111i\u1ec1u \u0111\u00f3 cho th\u1ea5y r\u1eb1ng ch\u00fang \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t theo c\u00e1c nguy\u00ean t\u1eafc GMP \u0111\u00e3 \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp, \u0111\u1ea3m b\u1ea3o cho ng\u01b0\u1eddi d\u00f9ng r\u1eb1ng m\u00f4i tr\u01b0\u1eddng n\u00e0y c\u00f3 ch\u1ea5t l\u01b0\u1ee3ng cao, an to\u00e0n v\u00e0 ph\u00f9 h\u1ee3p cho c\u00e1c \u1ee9ng d\u1ee5ng d\u1ef1 \u0111\u1ecbnh c\u1ee7a h\u1ecd, trong nghi\u00ean c\u1ee9u trong ph\u00f2ng th\u00ed nghi\u1ec7m ho\u1eb7c s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m sinh h\u1ecdc.<\/p>\n

\"\"<\/p>\n

Xcell Therapeutics, c\u00f4ng ty \u0111\u00e3 ph\u00e1t tri\u1ec3n m\u00f4i tr\u01b0\u1eddng x\u00e1c \u0111\u1ecbnh h\u00f3a h\u1ecdc kh\u00f4ng c\u00f3 huy\u1ebft thanh \u0111\u1ea7u ti\u00ean tr\u00ean th\u1ebf gi\u1edbi.\u00a0T\u1ea5t c\u1ea3 c\u00e1c s\u1ea3n ph\u1ea9m c\u1ee7a Xcell Therapeutics \u0111\u1ec1u \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t tr\u1ef1c ti\u1ebfp t\u1ea1i nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t \u1edf Yongin v\u00e0 \u0111\u01b0\u1ee3c qu\u1ea3n l\u00fd theo ti\u00eau chu\u1ea9n Th\u1ef1c h\u00e0nh S\u1ea3n xu\u1ea5t T\u1ed1t (GMP).<\/p>\n

T\u00ecm hi\u1ec3u th\u00eam v\u1ec1 Xcell Therapeutics<\/a><\/p>\n

T\u00ecm hi\u1ec3u th\u00eam v\u1ec1 s\u1ea3n ph\u1ea9m c\u1ee7a Xcell Therapeutics:<\/p>\n

M\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o MSC CellCor\u2122 CD MSC AOF<\/em><\/a><\/p>\n

M\u00f4i tr\u01b0\u1eddng thu nh\u1eadn exosome \u2013 CellCor\u2122 EXO CD<\/a><\/em><\/p>\n

Ngu\u1ed3n tham kh\u1ea3o<\/strong><\/p>\n

McNair, G. (2023, October 10).\u00a0Biomanufacturing with GMP cell culture media: an interview with Maximilian Gert-Kleint – RegMedNet<\/i>. RegMedNet.\u00a0https:\/\/www.regmednet.com\/biomanufacturing-with-gmp-cell-culture-media-an-interview-with-maximilian-gert-kleint_promocell\/<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Khi \u0111\u1ec1 c\u1eadp \u0111\u1ebfn m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o \u201c\u0111\u1ea1t ti\u00eau chu\u1ea9n GMP\u201d ho\u1eb7c \u201ctu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n GMP\u201d, \u0111i\u1ec1u \u0111\u00f3 c\u00f3 ngh\u0129a l\u00e0 m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m so\u00e1t theo c\u00e1c nguy\u00ean t\u1eafc Th\u1ef1c h\u00e0nh S\u1ea3n xu\u1ea5t T\u1ed1t (Good Manufacturing Practices – GMP). GMP l\u00e0 m\u1ed9t b\u1ed9<\/p>\n

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