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藥明生物(02269.HK)實現全連續生產工藝 中試規模日均產量高達每公升6克
阿思達克 11-22 11:08
藥明生物(02269.HK)宣布,在上海非GMP中試生產車間,通過超高效連續生物工藝平台WuXiUPTM,完成了中試規模的端到端原液生產,實現全連續生產工藝,上游總時長25天的連續細胞培養總產量高達每公升105克,其中在18天的抗體表達階段每日平均產量高達每公升6克。。 通過WuXiUPTM端到端連續原液生產技術,應用1,000升一次性生物反應器生產單抗可以實現每批次產量超過60公斤,每年產量達到約800公斤,與1萬升至2萬升傳統生物反應器產能相當。藥明生物預料將顯著加快生物藥上市進程,並且降低商業化產品生產成本及對廠房空間面積要求。 公司表示,目前該生物工藝正放大至GMP生產規模,未來也將在公司中國、愛爾蘭、美國、新加坡等全球基地推廣。
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