Panapitakkul Chalisa, Bulaon Christine Joy I, Pisuttinusart Nuttapat, Phoolcharoen Waranyoo
Baiya Phytopharm Co., Ltd., Bangkok, 10330, Thailand.
Center of Excellence in Plant-produced Pharmaceuticals, Chulalongkorn University, Bangkok 10330, Thailand.
Biotechnol Rep (Amst). 2024 Sep 16;44:e00856. doi: 10.1016/j.btre.2024.e00856. eCollection 2024 Dec.
Host cell proteins (HCPs) are process-related impurities found in biopharmaceutical products that can impair their safety and efficacy. While ELISA has traditionally been employed to quantify HCPs, LC-MS emerges as a powerful alternative for precise identification of individual HCPs. In this study, we used LC-MS for profiling HCPs from Nicotiana benthamiana-derived biopharmaceuticals. Our approach involved rigorous false discovery rate control to ensure data integrity and reliability. Comprehensive analysis revealed a systematic reduction of HCPs following purification, demonstrating the efficiency of purification processes in removing non-essential proteins. Furthermore, LC-MS enabled the identification of potential contaminants, refining purification strategies and improving product purity and integrity. Our findings highlight the potential of LC-MS as an analytical tool for HCPs analysis in biopharmaceutical development and manufacturing. By providing detailed insights into HCPs profiles and contaminants, LC-MS facilitates informed decision-making in downstream processing steps, benefiting product quality, patient safety, and the biopharmaceutical sector.
宿主细胞蛋白（HCPs）是生物制药产品中发现的与工艺相关的杂质，会损害其安全性和有效性。虽然传统上采用酶联免疫吸附测定（ELISA）来定量HCPs，但液相色谱-质谱联用（LC-MS）成为精确鉴定单个HCPs的有力替代方法。在本研究中，我们使用LC-MS对源自本氏烟草的生物制药产品中的HCPs进行分析。我们的方法涉及严格的错误发现率控制，以确保数据的完整性和可靠性。全面分析显示，纯化后HCPs系统性减少，证明了纯化工艺在去除非必需蛋白方面的效率。此外，LC-MS能够鉴定潜在污染物，完善纯化策略，提高产品纯度和完整性。我们的研究结果突出了LC-MS作为生物制药开发和生产中HCPs分析的一种分析工具的潜力。通过提供有关HCPs图谱和污染物的详细见解，LC-MS有助于在下游加工步骤中做出明智决策，有益于产品质量、患者安全和生物制药行业。
