Simultaneously, a pronounced need to improve engineering and controlled manufacturing principles has been made clear. Initiatives have emerged to accelerate cell therapy manufacturing innovations at academic institutions, including the NSF Engineering Research Center for Cell Manufacturing Technologies (CMaT) ...
Aseptic Process Simulation (APS) - A simulation of the entire aseptic manufacturing process in order to verify the capability of the process to assure product sterility. Includes all aseptic operations associated with routine ...
GMP Cytokine and Growth Factor Manufacturing Facility for Cell Therapy Cell and gene therapies represent some of the most revolutionary medical treatments today. At Bio-Techne, our mission is to deliver innovative solutions that enable cell and gene therapies to reach more patients. We have invested...
Bioburden - The total number of microorganisms associated with a specific item such as personnel, manufacturing environments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials, or finished products. 生物负荷 - 与特定项目相关的微生物总数,例如人员、...
产品;成果;[数]乘积;作品production[prə'dʌkʃən]n.成果;产品;生产;作品GMPappliestothelifecyclestagesfromthemanufactureofinvestigationalmedicinalproducts,technologytransfer,commercialmanufacturingthroughtoproductdiscontinuation.(欧盟GMP附录第一章1.2)GMP旳应用贯穿于生产临床研究用药物、技术转移、商业化生产...
PackGene provides a one-stop solution for GMP plasmid projects including bacteria banking, process development, analytical methodology development, plasmid manufacturing, plasmid stability testing, and document preparation.
Manufacturing Excellence Optimize advanced therapy production with software designed for GMP. It’s one more way to align your workforce for ‘right first time manufacturing’. Built for GMP facility services Cell and gene therapies CDMOs Connect your departments ...
基因编辑细胞系定制服务 脱靶效应分析服务 基因表达调控服务 细胞系定制服务 双荧光素酶报告基因检测 微生物基因组改造 植物基因工程服务 植物CRISPR单碱基编辑 植物DNA-free基因编辑 RNAi诱导的植物基因沉默 植物基因过表达 植物锌指核酸酶(ZFNs)基因编辑 植物TALENs基因编辑 ...
Frank Song, Chairman and CEO of Eminence, commented, "From the very beginning, our focus has been firmly set on the field of cell culture media. After over seven years of growth, our factory in Changzhou has reached its capacity, and this new facility was designed leveraging t...
1 药品生产质量管理规范 GMP:Good ManufacturingPractice 2 国家食品与药品监督管理局 State Food and Drug Administration 3 总则 GeneralProvisions 4 《中华人民共和国药品管理法》 the DrugAdministration Law of the People's Republic of China 5 制剂 Preparation 6 原料药 API: Active PharmaceuticalIngre...