Arden N Sarah, Fisher Adam C, Tyner Katherine, Yu Lawrence X, Lee Sau L, Kopcha Michael
Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
Int J Pharm. 2021 Jun 1;602:120554. doi: 10.1016/j.ijpharm.2021.120554. Epub 2021 Mar 29.
Over the last two centuries, medicines have evolved from crude herbal and botanical preparations into more complex manufacturing of sophisticated drug products and dosage forms. Along with the evolution of medicines, the manufacturing practices for their production have advanced from small-scale manual processing with simple tools to large-scale production as part of a trillion-dollar pharmaceutical industry. Today's pharmaceutical manufacturing technologies continue to evolve as the internet of things, artificial intelligence, robotics, and advanced computing begin to challenge the traditional approaches, practices, and business models for the manufacture of pharmaceuticals. The application of these technologies has the potential to dramatically increase the agility, efficiency, flexibility, and quality of the industrial production of medicines. How these technologies are deployed on the journey from data collection to the hallmark digital maturity of Industry 4.0 will define the next generation of pharmaceutical manufacturing. Acheiving the benefits of this future requires a vision for it and an understanding of the extant regulatory, technical, and logistical barriers to realizing it.
在过去的两个世纪里，药物已从粗制的草药和植物制剂发展到更为复杂的精密药品和剂型的制造。随着药物的演变，其生产的制造工艺已从使用简单工具的小规模手工加工发展到作为万亿美元制药行业一部分的大规模生产。随着物联网、人工智能、机器人技术和先进计算开始挑战传统的制药制造方法、实践和商业模式，当今的制药制造技术也在不断发展。这些技术的应用有可能极大地提高药品工业生产的敏捷性、效率、灵活性和质量。这些技术如何在从数据收集到工业4.0标志性数字成熟度的过程中得到应用，将定义下一代制药制造。要实现这一未来的好处，需要对其有一个愿景，并了解实现它所存在的监管、技术和后勤障碍。
