BIOMEDICAL (BASIC)

用于癌症治疗的生物药物的开发通常需要必须进行冻干的制剂，以产生可储存和重组的稳定产品。控制冻干饼中的残余水分含量对其贮藏稳定性至关重要。对于许多药物，残留水分水平<1%，但对于一些蛋白质类药物，将产品干燥到这个水平会导致构象稳定性降低，产品质量和效力下降。尽管残余水分水平很重要，但目前还没有在线方法来确定过程终点。

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.