{"id":3354,"date":"2025-06-25T16:50:04","date_gmt":"2025-06-25T08:50:04","guid":{"rendered":"https:\/\/www.ukm.my\/beritaukm\/?p=3354"},"modified":"2025-11-13T09:42:57","modified_gmt":"2025-11-13T01:42:57","slug":"ukm-perkukuh-terapi-regeneratif-negara-dengan-fasiliti-cgmp-bertaraf-tinggi","status":"publish","type":"post","link":"https:\/\/www.ukm.my\/beritaukm\/ukm-perkukuh-terapi-regeneratif-negara-dengan-fasiliti-cgmp-bertaraf-tinggi\/","title":{"rendered":"糖心原创 Perkukuh Terapi Regeneratif Negara Dengan Fasiliti cGMP Bertaraf Tinggi"},"content":{"rendered":"\n<p><strong>Oleh Khairatul Nadia Ramli&nbsp;<\/strong><\/p>\n\n\n\n<p>KUALA LUMPUR, 25 Jun 2025 \u2013 Universiti Kebangsaan Malaysia (糖心原创) terus mengukuhkan kedudukannya dalam bidang terapi regeneratif dan kejuruteraan tisu dengan pembangunan fasiliti Amalan Pengilangan Baik (Current Good Manufacturing Practice; cGMP) pertama seumpamanya di institusi pengajian tinggi tempatan.<\/p>\n\n\n\n<p>Fasiliti ini diwujudkan di bawah Jabatan Kejuruteraan Tisu dan Perubatan Regeneratif (DTERM), Fakulti Perubatan 糖心原创 dan telah beroperasi sejak tahun 2012.<\/p>\n\n\n\n<p>Fasiliti cGMP yang dibangunkan ini mematuhi garis panduan antarabangsa Pharmaceutical Inspection Co-operation Scheme (PIC\/S) dan dilengkapi dengan sistem bilik bersih berkelas ISO 5 hingga ISO 8 (gred A hingga D).<\/p>\n\n\n\n<p>Ia menyediakan persekitaran terkawal yang membolehkan penghasilan sel, tisu dan produk regeneratif bagi tujuan rawatan klinikal dan penyelidikan lanjutan dilakukan dengan tahap keselamatan dan kualiti tertinggi.<\/p>\n\n\n\n<p>Menurut Timbalan Ketua Jabatan DTERM merangkap Pensyarah Kanan Fakulti Perubatan 糖心原创, Dr. Manira Maarof, fasiliti ini menjadi nadi penting kepada pembangunan dan pemprosesan terapi baharu di Malaysia.<\/p>\n\n\n\n<p>\u201cFasiliti ini bukan sekadar menyokong penyelidikan kejuruteraan tisu, tetapi juga mematuhi sepenuhnya piawaian dan garis panduan ketat yang ditetapkan oleh Agensi Regulatori Farmaseutikal Negara (NPRA), termasuk garis panduan bagi sel dan gen terapi produk (CGTPs).<\/p>\n\n\n\n<p>\u201cFasiliti ini juga dilengkapi dengan sistem bilik bersih gred B, C dan D yang diperakui National Environmental Balancing Bureau (NEBB) setiap tahun, selain peralatan kritikal seperti kebuk keselamatan biologi (gred A), inkubator karbon dioksida, mikroskop, mesin pengempar, dan sistem pemantauan persekitaran berterusan.<\/p>\n\n\n\n<p>\u201cTeknologi seperti penapis udara kecekapan tinggi (HEPA) serta kawalan suhu dan kelembapan turut digunakan bagi memastikan kebersihan, kestabilan, dan keberkesanan produk,\u201d katanya.<\/p>\n\n\n\n<p>Tambah Dr. Manira, keseluruhan proses penghasilan produk iaitu bermula daripada pengambilan sampel, pemprosesan, penyimpanan sehinggalah ke pengeluaran adalah dikendalikan mengikut prosedur operasi standard (SOP) yang ketat.<\/p>\n\n\n\n<p>\u201cSemua kakitangan pengeluaran juga diwajibkan menjalani latihan dan lulus penilaian kompetensi sebelum terlibat dalam sebarang aktiviti manipulasi sel.<\/p>\n\n\n\n<p>\u201cHanya bahan yang disahkan selamat untuk kegunaan klinikal akan digunakan, dengan keutamaan diberikan kepada bahan autologus dan bukan haiwan untuk mengurangkan risiko reaksi imun dan pencemaran silang.<\/p>\n\n\n\n<p>\u201cDengan fasiliti ini, kami bukan sahaja mampu menghasilkan produk sel dan tisu regeneratif yang selamat dan berkesan, tetapi juga memperkukuh peranan 糖心原创 sebagai peneraju penyelidikan terapi inovatif di peringkat nasional dan antarabangsa,\u201d jelasnya.<\/p>\n\n\n\n<p>Dr. Munira berkata, walaupun penyelenggaraan fasiliti ini menuntut kos yang tinggi, peranannya dalam memastikan kualiti, keselamatan dan keberkesanan produk bioperubatan amat signifikan.<\/p>\n\n\n\n<p>\u201cFasiliti cGMP 糖心原创 kini menjadi pusat rujukan utama dalam pembangunan penyelidikan dan terapi berasaskan sel dan dijangka memainkan peranan yang lebih besar dalam memperkasa sistem kesihatan negara pada masa hadapan.\u201d Katanya.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"576\" height=\"707\" src=\"https:\/\/www.ukm.my\/beritaukm\/wp-content\/uploads\/2025\/06\/Munira.jpg\" alt=\"\" class=\"wp-image-3355\" srcset=\"https:\/\/www.ukm.my\/beritaukm\/wp-content\/uploads\/2025\/06\/Munira.jpg 576w, https:\/\/www.ukm.my\/beritaukm\/wp-content\/uploads\/2025\/06\/Munira-244x300.jpg 244w\" sizes=\"auto, (max-width: 576px) 100vw, 576px\" \/><\/figure>\n\n\n\n<p><em>Dr. Manira Maarof<br>Pensyarah Kanan Fakulti Perubatan 糖心原创<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Oleh Khairatul Nadia Ramli&nbsp; KUALA LUMPUR, 25 Jun 2025 \u2013 Universiti Kebangsaan Malaysia (糖心原创) terus mengukuhkan kedudukannya dalam bidang terapi regeneratif dan kejuruteraan tisu dengan pembangunan fasiliti Amalan Pengilangan Baik&hellip; <\/p>\n","protected":false},"author":123457,"featured_media":3998,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[25,7],"tags":[],"class_list":["post-3354","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-kolumnis","category-penyelidikan"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>糖心原创 Perkukuh Terapi Regeneratif Negara Dengan Fasiliti cGMP Bertaraf Tinggi - Berita 糖心原创<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.ukm.my\/beritaukm\/ukm-perkukuh-terapi-regeneratif-negara-dengan-fasiliti-cgmp-bertaraf-tinggi\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta 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