据悉，在今年10月，药明生物爱尔兰多产品生产基地顺利通过HPRA的全面现场检查，检查范围覆盖数据管理、工艺控制、人员管理、生产、存储及分析等全流程的GMP合规性要求，并获得了GMP认证。此次GMP认证再次印证了其遵守法规监管标准的承诺，未来药明生物爱尔兰基地将进一步为全球客户提供临床和商业化生物药原液生产服务，惠及广大病患。Wuxi Bio (02269) rose over 3%, as of this report, up 3.53%, priced at 17.02 Hong Kong dollars, with a transaction volume of 0.238 billion Hong Kong dollars.
According to Zhitong Finance APP, Wuxi Bio (02269) rose over 3%, as of this report, up 3.53%, priced at 17.02 Hong Kong dollars, with a transaction volume of 0.238 billion Hong Kong dollars.
On the news front, according to market reports, on December 6, Wuxi Bio announced that its advanced green production base located in Ireland achieved several important business advancements. The company's biopharmaceutical bulk solution production facility MFG7 completed multi-batch 16,000-liter scale process performance qualification (PPQ) production. The base has currently successfully completed PPQ production for two projects with a 100% success rate, and simultaneously received GMP certification from the Health Products Regulatory Authority (HPRA) for all three biopharmaceutical bulk solution manufacturing facilities.
It is reported that in October this year, Wuxi Bio's Ireland multi-product production base successfully passed a comprehensive on-site inspection by the HPRA, covering GMP compliance requirements across the entire process from data management, process control, personnel management, production, storage to analysis, and obtained GMP certification. This GMP certification reaffirms its commitment to adhering to regulatory standards, and in the future, Wuxi Bio's Ireland base will further provide clinical and commercial biopharmaceutical bulk solution production services to global customers, benefiting a wide range of patients.