单克隆抗体（mAb）生物仿制药的开发是一个复杂的过程。他们成功开发和商业化的关键是深入了解影响安全性和有效性的关键产品属性以及控制它们的策略。mAb的功能评估是生物制药药物可比性的关键部分。相关和强大的功能测定的开发需要跨学科的方法和足够的灵活性，以平衡监管问题以及生产过程中的动态和可变性。尽管许多先进的工具可用于研究和比较蛋白质的效力和生物活性，这些技术中的大多数都存在限制其常规使用的主要缺点。这些包括任务的复杂性，建立所选方法与生物仿制药作用机制(MOA)的相关性，成本和分析时间的延长，以及对结果数据的解释往往含糊不清。为了克服或应对这些挑战，使用多种正交技术是必要的先决条件。
The development of monoclonal antibody (mAb) biosimilars is a complex process. The key to their successful development and commercialization is an in-depth understanding of the key product attributes that impact safety and efficacy and the strategies to control them. Functional assessment of mAb is a crucial part of the comparability of biopharmaceutical drugs. The development of a relevant and robust functional assay requires an interdisciplinary approach and sufficient flexibility to balance regulatory concerns as well as dynamics and variability during the manufacturing process. Although many advanced tools are available to study and compare the potency and bioactivity of the protein, most of these techniques suffer from major shortcomings that limit their routine use. These include the complexity of the task, establishment of the relevance of the chosen method with the mechanism of action (MOA) of the biosimilar, cost and extended time of analysis, and often the ambiguity in interpretation of the resulting data. To overcome or to address these challenges, the use of multiple orthogonal state-of-the-art techniques is a necessary prerequisite.
