分子生物学和分子遗传学的进步以及免疫学和肿瘤学的重大科学突破导致了生物治疗的快速发展。他们的成功使药物发现和开发过程中的几乎每一步都发生了重大变化。生物制品是由活生物体产生的，筛选文库是通过免疫或噬菌体展示产生的。先导化合物优化利用复杂的蛋白质工程来改善药物样特性和靶向特异性。生物制品的制造过程非常复杂，需要高度专业化的设施。药理学和安全性的确定必须克服与物种特异性相关的并发症。由于临床前数据的预测效用有限，初始临床测试必须更加缓慢和谨慎地进行。总之，生物疗法已经极大地改变了药物发现和开发过程，并将随着基于信使 RNA 的疗法的引入和人工智能的应用而继续发展。

Advances in molecular biology and molecular genetics as well as major scientific breakthroughs in immunology and oncology have led to the rapid growth of biologic therapeutics. Their success has resulted in significant changes to virtually every step in the drug discovery and development process. Biologics are produced by living organisms, and screening libraries are generated by immunization or phage display. Lead optimization utilizes sophisticated protein engineering to improve drug-like properties and targeting specificity. The manufacturing process for biologics is complex and requires highly specialized facilities. Determination of pharmacology and safety must overcome the complications associated with species specificity. Initial clinical testing must proceed more slowly and carefully due to the limited predictive utility of preclinical data. In summary, the drug discovery and development process has been dramatically altered by biologic therapeutics and will continue to evolve with the introduction of messenger RNA-based therapeutics and the application of artificial intelligence.