中信国健 CPGJ
上海中信国健药业股份有限公司(CPGJ)是由中国中信集团公司和上海兰生国健药业 有限公司共同投资的生物医药高新技术企业,专注于抗体药物的研发、中试和产业化。公司自2002年创建以来,经过长期的不懈努力,现已成为国内抗体药物企业的领军者,提供覆盖抗肿瘤、移植、自身免疫系统等重大疾病领域的靶向药物,其应用效果得到了医师和患者的广泛赞誉。
作为一家以研发为基础的生物制药公司,中信国健已成功建立了国内领先的抗体药物开发和产业化生产平台,掌握了尖端的核心技术,并具备了持续开发新药的创新能力。公司正在研制、临床和销售的抗体新药达十多个,填补了国内抗体药物领域的多个空白,研发实力和生产能力均处于国际领先水平。
现代化的生产设备,领先的生产工艺,严格的质量控制,确保了中信国健为患者提供优质的医药产品。作为亚洲规模最大的哺乳动物细胞培养生产基地之一,公司拥有国内最先进的3条750升、2条3000升的真核细胞培养生产线;同时,6条符合欧盟标准的5000升生产线正在建设中。公司还特别设计建立了涵盖影响药品质量所有因素,包括物料管理、生产管理、质量控制、质量保证、设备设施和包装标签的完善质量管理体系,其3000升生产线采用了具有国际领先水平的现场总线控制系统(FCS)以及过程控制系统(PCS),该系统运用到的Delta VTM 数字自动化技术,对药品的整个生产过程进行严密地不间断地监测,最大程度地消除产品质量隐患和潜在的质量风险。
展望未来,中信国健将继续发挥其在生物技术领域的研发优势,为社会提供更多高效的靶向治疗药物。
Shanghai CP Guojian Pharmaceutical Co., Ltd. (CPGJ) is a bio-pharmaceutical high-tech company which is co-invested by the CITIC Group and Shanghai Lansheng Guojian Pharmaceutical Co., Ltd. We focus on the R&D, pilot test and industrialization of antibody drugs. It has become a leader in the domestic antibody class of bio-pharmaceutical companies through long-term efforts, and providing targeted drugs covering major disease fields of Oncology, Transplantation, Systemic autoimmune diseases & etc.; its application effects have gained widespread recognition by physicians and patients.
As a bio-pharmaceutical company relying greatly on Research & Development, CPGJ has successfully built a leading domestic platform for the development of Antibody Drugs and their industrialization production, grasped sophisticated core technologies and now possesses the innovation ability to continuously develop new drugs. There are currently more than 10 new Antibody Drugs under development, clinical trials or sales, which have filled a crucial void in the domestic biomedical field, and its R&D strength and production capacity had reached international advanced levels.
The modern production equipments, leading production technology and strict quality control have ensured that CPGJ can provide high-quality medicines for patients. As one of the largest Asian production base for mammalian cells, CPGJ has obtained three 750-liters and two 3,000-liters most advanced eukaryotic cell culture production lines in China. Recently six 5000-liter lines are under construction by follow of the European Union's strict standards. The consummation quality control system included materials management, production management, QC, QA, equipment and packaging label is ensured the high volumes of quality products are produced. The 3,000-liter production lines adopted the internationally leading Field bus Control System (FCS) and the Process Control System, which used the latest DeltaVTM digital automation technology. It is continuously monitored during the whole processes in order to maximize the elimination of potential product quality risks.
Looking into the future, CPGJ will continue to make the most of the advantage in its R&D strength in the biotechnology field, and providing more effective targeted therapeutic drugs for society.