科濟藥業-B(02171.HK):北卡羅來納州三角研究園生產工廠開始運營
格隆匯2月21日丨科濟藥業-B(02171.HK)發佈公吿,公司旗下美國子公司CARsgen Therapeutics Corporation在美國北卡羅來納州的三角研究園(RTP)區域建設的現行藥品生產質量管理規範(CGMP)生產工廠已通過官方檢查。科濟藥業已獲得達勒姆市縣檢驗局頒發的合規證書,並啟動臨牀生產運營。
啟動運營的裝備最先進技術的RTP生產工廠,總建築面積約為3300平方米,將提升科濟藥業的自體CAR-T細胞產品生產能力,每年可以為700名患者提供服務。此RTP生產工廠將支援公司在北美和歐洲的臨牀研究和早期商業化。科濟藥業已開始為RTP生產工廠的運營建立一支世界級的CMC團隊。
RTP生產工廠採用了一體化的專案交付方法,大大縮短了施工週轉時間,提高了成本效益。該項目已獲得北卡羅來納州達勒姆縣和達勒姆市的人才發展投資基金(JDIG)支援以及其他投資激勵。為了加快RTP生產工廠的臨牀生產,科濟藥業位於中國上海金山的GMP生產工廠,將繼續給獲得美國FDA的IND批准的CT053和CT041臨牀研究提供用於製造CAR-T細胞產品的慢病毒載體物質。科濟藥業已經建立了可持續和可擴展的慢病毒載體GMP生產能力。金山生產工廠的大規模生產病毒載體物質的能力將大大降低CAR-T細胞產品的製造成本。
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