Yoshiura Hiromu, Kawata Yayoi, Sengoku Shintaro
Department of Innovation Science, School of Environment and Society, Tokyo Institute of Technology, Tokyo, Japan.
Ther Innov Regul Sci. 2025 Jan;59(1):63-70. doi: 10.1007/s43441-024-00701-x. Epub 2024 Oct 28.
Ensuring regulatory-compliant manufacturing capability is an essential challenge for new treatment modalities, but its internalisation is not easy for pharmaceutical companies, especially start-ups. This study examines the functions and requirements of contracted development and manufacturing organisations (CDMOs) using the development process of antibody medicines as a case study.
Utilizing PubMed, Cortellis and Patent Integration databases, this study delves into publication and contractual trends in monoclonal antibody drugs (mAbs) development, alongside an analysis of patent filings by CDMOs, offering a comprehensive overview of the evolving landscape in mAbs innovation.
In the early stages of mAbs development, dedicated bio firms (DBFs) led R&D with superior drug discovery technology but lacked manufacturing capability, which was complemented by CDMOs. This collaboration was an opportunity for CDMOs to expand their capabilities beyond manufacturing technology into antibody drug candidate discovery and structural optimisation technology. From mid-development onwards, it established a technology platform based on these capabilities and developed and established partnerships with existing pharmaceutical companies, including mega pharma.
The impact of institutions and regulations on the innovation process was assessed during this development process. These findings are expected to provide valuable insights into the innovation system for new modalities.
确保符合监管要求的生产能力是新治疗方式面临的一项重要挑战，但对于制药公司，尤其是初创企业来说，将其内部化并非易事。本研究以抗体药物的研发过程为例，考察了合同研发生产组织（CDMO）的功能和要求。
本研究利用PubMed、Cortellis和专利整合数据库，深入研究单克隆抗体药物（mAb）研发中的发表和合同趋势，并分析CDMO的专利申请情况，全面概述mAb创新的演变态势。
在mAb研发的早期阶段，专注于生物领域的公司（DBF）凭借卓越的药物发现技术引领研发，但缺乏生产能力，而CDMO则对其进行了补充。这种合作是CDMO将其能力从生产技术扩展到抗体药物候选物发现和结构优化技术的契机。从中期研发阶段起，CDMO基于这些能力建立了一个技术平台，并与包括大型制药公司在内的现有制药公司建立了合作关系。
在这一研发过程中评估了机构和法规对创新过程的影响。这些发现有望为新治疗方式的创新体系提供有价值的见解。
