Therapeutics based on monoclonal antibody (mAb) represent one of the most advanced biopharmaceuticals, being able to treat a wide range of challenging diseases such as cancers and arthritis. As the scale of mAb production steadily increases with the demand for mAb-based therapeutics, the downstream biopurification continues to experience significant bottleneck due to the throughput limited nature of the current purification technology. Over the last decades, significant advances have been made in protein (and especially mAb) crystallisation as an alternative biopurification technology that offers high product stability and purity as well as scalability. This review starts with the introduction of general physicochemical properties of mAb before moving on to the in-depth discussion of distinct phase behaviour of mAb in comparison with conventional globular proteins such as lysozyme. The final part of this review presents a summary of successful demonstrations of crystallisation scale-ups of mAb and discusses the critical factors (i.e. mixing and temperature control) to be considered.

基于单克隆抗体（mAb）的治疗药物代表了最先进的生物药物之一，能够治疗多种挑战性疾病，例如癌症和关节炎。随着基于mAb的治疗剂的需求，mAb的生产规模稳步增加，由于当前纯化技术的通量有限，下游生物纯化仍会遇到重大瓶颈。在过去的几十年中，作为替代性生物纯化技术的蛋白质（尤其是mAb）的结晶已取得了重大进展，该技术可提供高产品稳定性，纯度和可扩展性。这篇综述首先介绍了mAb的一般理化性质，然后再深入讨论与传统球状蛋白（如溶菌酶）相比，mAb的不同相行为。本综述的最后部分总结了mAb结晶放大成功的成功案例，并讨论了要考虑的关键因素（即混合和温度控制）。