Center for Molecular Biosciences Innsbruck (CMBI), Department of General, Inorganic and Theoretical Chemistry, University of Innsbruck, Innsbruck, Austria.
Department of Biotechnology and Biomedicine, Technical University of Denmark, Kongens Lyngby, Denmark.
MAbs. 2023 Jan-Dec;15(1):2171248. doi: 10.1080/19420862.2023.2171248.
Beyond potency, a good developability profile is a key attribute of a biological drug. Selecting and screening for such attributes early in the drug development process can save resources and avoid costly late-stage failures. Here, we review some of the most important developability properties that can be assessed early on for biologics. These include the influence of the source of the biologic, its biophysical and pharmacokinetic properties, and how well it can be expressed recombinantly. We furthermore present , and methods and techniques that can be exploited at different stages of the discovery process to identify molecules with liabilities and thereby facilitate the selection of the most optimal drug leads. Finally, we reflect on the most relevant developability parameters for injectable versus orally delivered biologics and provide an outlook toward what general trends are expected to rise in the development of biologics.
除了效力,良好的可开发性特征也是生物药物的一个关键属性。在药物开发过程的早期选择和筛选这些属性可以节省资源并避免代价高昂的后期失败。在这里,我们回顾了一些在早期阶段可以评估的最重要的可开发性特性。这些特性包括生物来源的影响、其生物物理和药代动力学特性以及其重组表达的能力。我们还介绍了可以在发现过程的不同阶段利用的方法和技术,以识别具有缺陷的分子,从而促进选择最佳的药物先导物。最后,我们反思了可开发性参数对于注射和口服生物药物的最相关方面,并展望了在生物药物开发中预计会出现的一些总体趋势。