Cell culture media (CCM) used in industrial biotechnology are complex mixtures of molecules and elements that are inherently difficult to analyze comprehensively. CCM quality analysis is of utmost importance for efficient production of protein-based therapeutics with the correct Critical Quality Attributes (CQAs). Here we discuss the use of rapid spectroscopic methods for routine screening of CCM molecular variance which include electronic (UV–vis absorption and fluorescence) and vibrational (Raman, FT-IR, and Near-Infra-red) spectroscopies. CCM analysis needs to provide: identity testing, compositional variance analysis (i.e. lot-to-lot variation), validation of media preparation protocols, and correlations with Critical Process Parameters (CPPs) or product CQAs. Rapid spectroscopic methods can fulfil some of these requirements but only with correct sample handling and preparation. Accurate analysis requires the use of chemometrics combined with a detailed knowledge of sample behavior such as water absorption and chemical stability.

工业生物技术中使用的细胞培养基（CCM）是分子和元素的复杂混合物，固有地难以进行全面分析。CCM质量分析对于有效生产具有正确关键质量属性（CQA）的蛋白质基治疗剂至关重要。在这里，我们讨论了使用快速光谱法常规筛查CCM分子变异的方法，包括电子光谱（紫外可见吸收和荧光）和振动光谱（拉曼光谱，傅立叶变换红外光谱和近红外光谱）。CCM分析需要提供：身份测试，成分差异分析（即批次之间的差异），介质制备方案的验证以及与关键过程参数（CPP）或产品CQA的相关性。快速光谱方法可以满足其中一些要求，但前提是必须正确处理和准备样品。准确的分析需要结合使用化学计量学以及对样品行为（如吸水率和化学稳定性）的详细了解。