科濟藥業(02171.HK)美RTP GMP生產工廠放行
科濟藥業-B(02171.HK)公佈,公司位於美國北卡羅來納州的三角研究園(RTP)區域符合現行藥品生產質量管理規範(CGMP)的生產工廠已經開始了自體CAR-T細胞產品的GMP生產,併成功放行了首批用於臨牀試驗的GMP批次。
涉及工廠總建築面積約3,300平方米,將提供每年700名患者生產自體CAR-T細胞產品的額外產能,用於支援在北美和歐洲的臨牀研究和早期商業化。
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