BIOMEDICAL (BASIC)

生物医学（基础）

• 批准号: 7962449
• 负责人: WILLIAM KESSLER
• 金额: $ 74.98万
• 依托单位: PHYSICAL SCIENCES, INC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-20 至 2011-07-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7962449
• 关键词: BIOMEDICAL; BASIC

The development of biological drugs for cancer treatment often requires formulations that must be lyophilized to produce stable products that can be stored and reconstituted. Control of the residual moisture content in the freeze-dried cake is critical for storage stability. For many drugs the residual moisture level is <1%, but for some protein-based drugs drying the product to this level results in reduced conformational stability and loss of product quality and potency. Despite the importance of the residual moisture level there is currently no on line method for determining the process endpoint.

用于癌症治疗的生物药物的开发通常需要必须冻干以产生可以储存和重构的稳定产品的制剂。控制冻干饼中的残留水分含量对于储存稳定性至关重要。对于许多药物，残留水分水平<1%，但对于一些基于蛋白质的药物，将产品干燥至该水平会导致构象稳定性降低以及产品质量和效力损失。尽管残留水分水平很重要，但目前还没有用于确定工艺终点的在线方法。