Process analytical technology (PAT) for the manufacture of monoclonal antibodies (mAbs) is defined by an integrated set of advanced and automated methods that analyze the compositions and biophysical properties of cell culture fluids, cell-free product streams, and biotherapeutic molecules that are ultimately formulated into concentrated products. In-line or near-line probes and systems are remarkably well developed, although challenges remain in the determination of the absence of viral loads, detecting microbial or mycoplasma contamination, and applying data-driven deep learning to process monitoring and soft sensors. In this review, we address the current status of PAT for both batch and continuous processing steps and discuss its potential impact on facilitating the continuous manufacture of biotherapeutics.

用于制造单克隆抗体 (mAb) 的过程分析技术 (PAT) 由一整套先进的自动化方法定义，这些方法分析细胞培养液、无细胞产品流和生物治疗分子的成分和生物物理特性，最终配制成浓缩产品。在线或近线探针和系统发展得非常好，尽管在确定是否存在病毒载量、检测微生物或支原体污染以及将数据驱动的深度学习应用于过程监控和软传感器方面仍然存在挑战。在这篇综述中，我们讨论了 PAT 在批处理和连续处理步骤中的现状，并讨论了它对促进生物治疗药物连续生产的潜在影响。