TO6 - GENERATING MONOCLONAL CELL LINES, MONOCLONAL ANTIBODIES, AND LABELED MONOCLONAL ANTIBODIES AGAINST HUMAN AND MOUSE COLQ

TO6 - 生成针对人类和小鼠 COLQ 的单克隆细胞系、单克隆抗体和标记单克隆抗体

• 批准号: 10953997
• 负责人: AKIVA KOSOWSKY
• 金额: $ 11.64万
• 依托单位: A AND G PHARMACEUTICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10953997
• 关键词: TO6; GENERATING; MONOCLONAL; CELL; LINES

NCATS needs Monoclonal antibodies for bioanalytical method development for expression, toxicokinetic and pharmacokinetic studies and immunogenicity assessment of AAV8-COLQ, a platform-based gene therapy drug candidate for the treatment of Congenital Myasthenic Syndrome (CMS). This task order defines the tasks which will be undertaken to produce monoclonal cell lines that generate antibodies with affinity to either the PRAD domain of COLQ or the Human epitope of Human COLQ, and purified monoclonal antibody preparations for this project and documentation suitable for use of these antibody preparations in regulated preclinical and clinical assays.

NCATS需要用于生物分析方法开发的单克隆抗体，用于AAV 8-COLOQ（一种用于治疗先天性肌无力综合征（CMS）的基于平台的基因治疗候选药物）的表达、毒代动力学和药代动力学研究以及免疫原性评估。本任务订单定义了将用于生产单克隆细胞系的任务，这些单克隆细胞系可产生对COLQ的PRAD结构域或人COLQ的人表位具有亲和力的抗体，以及本项目的纯化单克隆抗体制剂和适用于这些抗体制剂在受监管的临床前和临床试验中使用的文件。