Production of 50 mL fill of 1 mg/mL injectable LMP-744

生产 50 mL 填充液 1 mg/mL 可注射 LMP-744

• 批准号: 10044342
• 负责人: GIANNINI ROBERT
• 金额: $ 17.69万
• 依托单位: IRISYS, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-01-07 至 2019-10-06
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10044342
• 关键词: Clinical; Clinical Trials; Contractor; Injectable; Life; Pharmaceutical Preparations; Phase; Process; Production; repository

THIS AGENT IS BEING DEVELOPED IN SUPPORT OF ONGOING PHASE I/II CLINICAL TRIALS, THEREFORE THE PRODUCT IS NEEDED TO BE PRODUCED UNDER THE GMP CONDITION USING THE PROCESS USED TO PRODUCE LOT NUMBER 15LM. The batch of product was produced by the contractor and sent to clinical repository. The shelf-life was also evaluated. The drug product will be used in the NCI clinical trials.

该药物正在开发中，以支持正在进行的i / ii期临床试验，因此该产品需要在GMP条件下使用生产批号15lm的工艺生产。该批产品由承包商生产并送到临床库。并对其保质期进行了评价。该药品将用于NCI临床试验。