pat（过程分析技术）是生物制药行业的热门话题，也因它的诸多优势，一直被大家所关注。它本质上是一种基于产品（关键）质量属性的，对产品生产工艺进行测试和控制的方法。想要做到高效正确地使用pat技术，就要求准确检测关键过程参数（cpp）和产品质量属性(cqa)，并迅速完成数据收集。
to facilitate optimal process control limiting substrates must be identified, moni-tored and controlled. amino acids are often critical substances, especially in mam-malian processes. measurement and thus monitoring is tedious and rarely done.
hplc is the common reference method for product and metabolite analysis in bio-processes. sampling is needed for these analyses, resulting in off-line measure-ments along the process. in order to reduce time and cost expenses in process development a