Autolus Therapeutics receives Medicines and Healthcare products Regulatory Agency (MHRA) certification for Nucleus commercial manufacturing site
Autolus(AUTL) Newsfilter·2024-03-12 19:00
Autolus Therapeutics plc宣布Nucleus制造设施获得制造商进口授权和GMP证书 - Autolus的Nucleus工厂通过了MHRA的GMP检查,获得了两个新许可证,覆盖了临床和商业生产[1][2] Autolus的obe-cel获得了多项认定 - Autolus的obe-cel获得了FDA的孤儿药品认定、EMA的孤儿医疗产品认定、FDA的再生医学先进疗法认定和EMA的优先药物认定[4]