Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs.

IF 2 4区 医学 Q4 MEDICAL INFORMATICS Therapeutic innovation & regulatory science Pub Date : 2024-10-28 DOI:10.1007/s43441-024-00701-x
Hiromu Yoshiura, Yayoi Kawata, Shintaro Sengoku
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Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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新模式开发中的开放式创新和监管挑战:合同开发和制造组织在推动抗体药物发展中的关键作用。
背景:确保符合法规要求的制造能力是新治疗模式面临的一项基本挑战,但对于制药公司,尤其是新成立的公司来说,内部化并非易事。本研究以抗体药物的开发过程为例,探讨了合同开发和制造组织(CDMO)的职能和要求:本研究利用 PubMed、Cortellis 和 Patent Integration 数据库,深入研究了单克隆抗体药物(mAbs)开发过程中的出版和合同趋势,同时分析了 CDMO 的专利申请情况,从而全面概述了 mAbs 创新领域不断变化的格局:在 mAbs 开发的早期阶段,专业生物公司 (DBF) 凭借卓越的药物发现技术领导研发工作,但缺乏制造能力,CDMO 对此进行了补充。这种合作为 CDMO 提供了一个机会,使其能力从制造技术扩展到抗体候选药物的发现和结构优化技术。从开发中期开始,该公司建立了基于这些能力的技术平台,并与现有制药公司(包括大型制药公司)发展和建立了合作伙伴关系:结论:在这一开发过程中,对制度和法规对创新过程的影响进行了评估。这些发现有望为新模式的创新体系提供有价值的见解。
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来源期刊
Therapeutic innovation & regulatory science
Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY
CiteScore
3.40
自引率
13.30%
发文量
127
期刊介绍: Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations
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