西妥昔单抗采用 Erbitux® (5 mg/mL) 配制而成，是一种治疗性单克隆抗体 (mAb)，广泛用于多种癌症治疗。目前，对于西妥昔单抗的行为及其在医院的常规处理或无意的不当处理相关的风险，还缺乏足够的了解。强制降解研究可以模拟这些条件，并深入了解单克隆抗体的生物物理和生化特性。在这项研究中，我们对对照样品中和受控降解条件下（包括冷冻-）西妥昔单抗的关键质量属性进行了深入的理化和功能表征。解冻循环、加热、搅拌和光照。为了实现这一目的，我们使用了一套适当的分析技术，包括 CD、IT-FS、DLS、SE/UHPLC-UV、UHPLC-MS/MS 和 ELISA，以检查基于抗原抗体结合的功能。研究表明，光照是对药品影响最大的应激刺激，导致非天然低聚物的形成、蛋氨酸残基的断裂和氧化。此外，西妥昔单抗（Erbitux®，5 mg/mL）在 60 °C 下放置 1 小时时表现出聚集趋势。在功能方面，发现西妥昔单抗（Erbitux®，5 mg/mL）样品在经历冻融循环、60 °C（1 小时）以及暴露于光（室温偏移和加速的日光）时会受到影响。因此，我们建议 Erbitux® (5 mg/mL) 应避免受到这些环境条件的影响，因为它们会损害药品的安全性和有效性。

Cetuximab, formulated in Erbitux® (5 mg/mL), is a therapeutic monoclonal antibody (mAb) widely used in several cancer treatments. Currently, there is insufficient knowledge about the behavior of cetuximab with regard to the risk associated with its routine handling or unintentional mishandling in hospitals. Forced degradation studies can simulate these conditions and provide insights into the biophysical and biochemical properties of mAbs.In this study, we conducted a deep physicochemical and functional characterization of the critical quality attributes of cetuximab in control samples and under controlled degraded conditions, including freeze-thaw cycles, heat, agitation, and light exposure. To achieve this purpose, we used a set of proper analytical techniques, including CD, IT-FS, DLS, SE/UHPLC-UV, UHPLC-MS/MS, and ELISA, to check functionality based on antigen-antibody binding.The results revealed that light exposure was the stress stimuli with the greatest impact on the drug product, leading to the formation of non-natural oligomers, fragmentation, and oxidation of methionine residues. Additionally, cetuximab (Erbitux®, 5 mg/mL) showed a tendency to aggregate when submitted to 60 °C for 1 h. In terms of functionality, cetuximab (Erbitux®, 5 mg/mL) samples were found to be affected when subjected to freeze-thaw cycles, 60 °C (1 h), and when exposed to light (daylight with room temperature excursion and accelerated light exposure).Thus, we suggest that Erbitux® (5 mg/mL) should be shielded from these environmental conditions, as they compromise both the safety and efficacy of the drug product.