Molecular mass of reduced ARX788 drug substance.

ARX788 is an anti-HER2 antibody drug conjugate (ADC) developed using Ambrx proprietary Engineered Precision Biologics technology. The manufacturing process of ARX788 has been optimized during the course of early to late-phase clinical development. A comprehensive evaluation of side-by-side comparability between pre- and post-change process for ARX788 drug substance and drug product from a quality perspective was conducted based on ICH Q5E guidelines consisting of batch release assays, physicochemical and biophysical characterization, biological characterization, and forced degradation studies. All results have substantiated a high degree of similarity between the pre- and post-change ARX788 drug substance batches and drug product lots, demonstrating that the process manufacturing changes did not impact product quality.ARX788是采用安博克斯（Ambrx）专有的工程化精准生物制药技术开发的抗HER2抗体偶联药物（ADC）。该药物的生产工艺在从早期到晚期的临床开发阶段中完成了优化。本研究依据人用药品注册技术要求国际协调理事会（ICH）Q5E指导原则，从质量视角出发，对ARX788原料药与制剂的变更前后生产工艺开展了全面的同步可比性评估，评估内容涵盖批次放行检验、理化与生物物理表征、生物学表征以及强制降解试验。所有试验结果均证实，变更前后的ARX788原料药批次与制剂批次高度相似，证明生产工艺变更未对产品质量造成影响。