新浪登录
腾讯登录药明康德新建工厂加快占领CAR-T市场
| 导读 | 无锡药明康德官员表示,该公司将于美国费城建立一项新型cGMP工厂用于细胞疗法类产品生产。 |
无锡药明康德官员表示,该公司将于美国费城建立一项新型cGMP工厂用于细胞疗法类产品生产，该工厂总占地达14.5万平方英尺，投产产品包含嵌合抗原受体T细胞 (CAR T cell)疗法的相关产品，该疗法主要包括癌症患者T细胞的收集、体外靶向性改造与回收三个阶段。
截止至2016年中期，该工厂将成为无锡药明康德第三大细胞治疗产品生产基地。根据药明康德CEO兼主席李革透露的消息，这家工厂将通过单一合同对cGMP制造能力进行拓展，满足细胞治疗行业的独特需求。具体来说,新工厂将拓展药明康德现有的1.6万平方英尺的细胞治疗产品生产工厂，提升相关产品的生产能力和生产效率，满足药明康德在细胞治疗领域所占有的临床研究和商业供应市场。同时，预计至2015年中期，药明康德将建成总面积达4.5万平方英尺的同种异体和自体的细胞疗法产品生产工厂。
李革表示：“到2016年，药明康德于美国的20.6万平方英尺的制药工厂将满足该公司占有的细胞治疗市场在临床和商业方面的需求。新工厂将作为药明康德在费城原有产业的补充而与其整合，促进该地区业务的多项发展与生产生物安全性的完善。”（转化医学网360zhyx.com）
以上为转化医学网原创翻译整理，如需转载，请联系 info@360zhyx.com 。原文：（genengnews）
Officials at WuXi PharmaTech say the company will soon start construction of a new, 145,000-square-foot cGMP facility in Philadelphia for the manufacture of cell therapy products, which contain viral vectors such as chimeric antigen receptor T cell (CAR T cell) therapies. These are T cells harvested from a patient's body, engineered to target specific cancers, and then reintroduced into the body.
The new facility will become WuXi's third cell therapy manufacturing facility when it becomes operational by mid-2016. According to Ge Li, Ph.D., chairman and CEO of WuXi PharmaTech, the facility will provide single-source contract development and cGMP manufacturing capabilities to support the cellular therapeutic industry's unique requirements. Specifically, the new facility, which will provide manufacturing capability and capacity to meet the demand for clinical studies and commercial supply, will expand upon WuXi's existing 16,000-square-foot cGMP cell therapy manufacturing facility, as well as a 45,000-square-foot facility for the manufacturing of allogeneic and autologous cell-based therapeutics that is expected to be completed by mid-2015.
“By 2016, WuXi's available manufacturing capacity in the U.S. of 206,000 square feet would help meet the anticipated market needs of clinical and commercial production for cell-therapy companies. These facilities will complement the company's current fully integrated facility for biological safety and lot release testing in Philadelphia,” said Dr. Li.
还没有人评论，赶快抢个沙发