More than 370 biotherapeutics drug products have been approved by regulatory agencies on the US and EU markets and this industry continues to expand. Process change and optimization is necessary to develop new effective biologics in a cost effective and productive way. Consequently, improvement of analytical techniques is required for better product characterization according to Quality by Design (QbD) approach recommended by regulatory agencies. Recently, multi-attribute method (MAM) has emerged to meet such demands using mass spectrometry coupled to liquid chromatography (LC-MS). However, traditional sample preparation or data processing would not be suitable to guide process development, because one of the common challenges during development of analytical platforms is instrument or method variability which can cause deviation in results. Here, we show a new automated analytical platform for MAM implemented on 3 different sites: the components of MAM platform include automated sample preparation, LC-MS based MAM, and data treatment automation. To our knowledge, this is the first study to show global harmonization on automated MAM platforms and the inter-sites comparability including the automated sample preparation and LC-MS instrument. Also, we demonstrate the applicability of MAM to support cell line development, cell culture process development and downstream process development. We expect that this MAM platform will effectively guide process development across multiple projects.

监管机构已在美国和欧盟市场上批准了370多种生物治疗药物产品，并且该行业正在不断扩大。为了以经济高效的方式开发新的有效生物制剂，必须进行过程更改和优化。因此，根据监管机构建议的“设计质量”（QbD）方法，需要改进分析技术以更好地表征产品。近来，已经出现了使用质谱联用液相色谱（LC-MS）的多属性方法（MAM）来满足此类需求。但是，传统的样品制备或数据处理不适合指导过程开发，因为分析平台开发过程中的常见挑战之一是仪器或方法的可变性，这可能会导致结果出现偏差。这里，我们展示了一个在3个不同站点上实施的MAM自动化分析平台：MAM平台的组件包括自动样品制备，基于LC-MS的MAM和数据处理自动化。据我们所知，这是第一项显示自动化MAM平台在全球范围内协调一致以及站点间可比性（包括自动化样品制备和LC-MS仪器）的研究。此外，我们证明了MAM在支持细胞系开发，细胞培养过程开发和下游过程开发中的适用性。我们希望该MAM平台将有效地指导多个项目的流程开发。据我们所知，这是第一项显示自动化MAM平台在全球范围内协调一致以及站点间可比性（包括自动化样品制备和LC-MS仪器）的研究。此外，我们证明了MAM在支持细胞系开发，细胞培养过程开发和下游过程开发中的适用性。我们希望该MAM平台将有效地指导多个项目的流程开发。据我们所知，这是第一项显示自动化MAM平台在全球范围内协调一致以及站点间可比性（包括自动化样品制备和LC-MS仪器）的研究。此外，我们证明了MAM在支持细胞系开发，细胞培养过程开发和下游过程开发中的适用性。我们希望这个MAM平台将有效地指导多个项目的流程开发。