Advances in gene editing and cell therapies have recently led to outstanding clinical successes. However, the lack of a cost-effective manufacturing process prevents the democratization of these innovative medical tools. Due to the common use of viral vectors, the step of transfection in which cells are engineered to gain new functions, is a major bottleneck in making safe and affordable cell products. A promising opportunity lies in Single-Cell Transfection Technologies (SCTTs). SCTTs have demonstrated higher efficiency, safety and scalability than conventional transfection methods. They can also feature unique abilities such as substantial dosage control over the cargo delivery, single-cell addressability and integration in microdevices comprising multiple monitoring modalities. Unfortunately, the potential of SCTTs is not fully appreciated: they are most often restricted to research settings with little adoption in clinical settings. To encourage their adoption, we review and compare recent developments in SCTTs, and how they can enable selected clinical applications. To help bridge the gap between fundamental research and its translation to the clinic, we also describe how Good Manufacturing Practices (GMP) can be integrated in the design of SCTTs.

基因编辑和细胞疗法的进步最近导致了杰出的临床成功。然而，缺乏具有成本效益的制造过程阻止了这些创新医疗工具的民主化。由于病毒载体的普遍使用，将细胞改造成具有新功能的转染步骤是生产安全，负担得起的细胞产品的主要瓶颈。单细胞转染技术（SCTT）是一个有前途的机会。与传统的转染方法相比，SCTT具有更高的效率，安全性和可扩展性。它们还可以具有独特的功能，例如对货运的实质性剂量控制，单细胞寻址能力以及与包含多种监控方式的微型设备的集成。不幸的是，SCTT的潜力尚未得到充分认识：他们通常仅限于研究环境，很少在临床环境中采用。为鼓励其采用，我们回顾并比较了SCTT的最新发展，以及它们如何实现选定的临床应用。为了帮助弥合基础研究与其在临床上的翻译之间的鸿沟，我们还描述了如何在SCTT的设计中整合良好生产规范（GMP）。