Willis Leon F, Kapur Nikil, Radford Sheena E, Brockwell David J
School of Molecular and Cellular Biology, Astbury Centre for Structural Molecular Biology, Faculty of Biological Sciences, University of Leeds, Leeds, LS2 9JT, UK.
School of Mechanical Engineering, Faculty of Engineering and Physical Sciences, University of Leeds, Leeds, LS2 9JT, UK.
Biologics. 2024 Dec 21;18:413-432. doi: 10.2147/BTT.S486345. eCollection 2024.
The successful progression of therapeutic antibodies and other biologics from the laboratory to the clinic depends on their possession of "drug-like" biophysical properties. The techniques and the resultant biophysical and biochemical parameters used to characterize their ease of manufacture can be broadly defined as developability. Focusing on antibodies, this review firstly discusses established and emerging biophysical techniques used to probe the early-stage developability of biologics, aimed towards those new to the field. Secondly, we describe the inter-relationships and redundancies amongst developability assays and how in silico methods aid the efficient deployment of developability to bring a new generation of cost-effective therapeutic proteins from bench to bedside more quickly and sustainably.
治疗性抗体和其他生物制品从实验室成功推进到临床取决于它们具备“类药物”的生物物理特性。用于表征其易于制造的技术以及由此产生的生物物理和生化参数可广义地定义为可开发性。本文聚焦于抗体，首先讨论用于探究生物制品早期可开发性的既定和新兴生物物理技术，目标受众是该领域的新手。其次，我们描述了可开发性检测之间的相互关系和冗余性，以及计算机模拟方法如何有助于有效利用可开发性，以便更快、更可持续地将新一代具有成本效益的治疗性蛋白质从实验室推向临床应用。
