Chen Chun, Garcia Zoe, Chen David, Liu Hong, Trelstad Piper
Chemistry, Manufacturing and Controls, Bill & Melinda Gates Medical Research Institute, Cambridge, MA, USA.
MAbs. 2025 Dec;17(1):2451789. doi: 10.1080/19420862.2025.2451789. Epub 2025 Jan 19.
Monoclonal antibodies (mAbs) and mAb-derived biologics have achieved substantial success across various therapeutic areas over recent decades. Their widespread adoption, however, remains constrained due to high prices and challenges in supply. Here, we examine the general price and cost structure of mAbs and mAb-derived therapeutics and identify directions to improve affordability and strategies to ensure supply. Mainstream and emerging biomanufacturing formats and their implications on cost and supply are discussed. We also summarize modeling tools used across industry for process economics analysis, emphasizing the importance of this assessment throughout the product development lifecycle. A comprehensive understanding of cost and supply scenarios will empower industry players to thrive despite competition, navigate supply challenges, and broaden access to mAb therapeutics for more patients.
近几十年来，单克隆抗体（mAb）和源自单克隆抗体的生物制品在各个治疗领域都取得了巨大成功。然而，由于价格高昂和供应方面的挑战，它们的广泛应用仍然受到限制。在此，我们研究了单克隆抗体和源自单克隆抗体的治疗药物的一般价格和成本结构，并确定了提高可承受性的方向以及确保供应的策略。讨论了主流和新兴的生物制造形式及其对成本和供应的影响。我们还总结了整个行业用于工艺经济学分析的建模工具，强调了在产品开发生命周期中进行这种评估的重要性。对成本和供应情况的全面理解将使行业参与者能够在竞争中蓬勃发展，应对供应挑战，并为更多患者扩大单克隆抗体治疗药物的可及性。
