Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs.
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 manufact...
| Published in: | Therapeutic Innovation & Regulatory Science Vol. 59; no. 1; pp. 63 - 71 |
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| Main Authors: | , , |
| Format: | research tables/charts Journal Article |
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Springer Nature
Jan2025
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=182099783&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 182099783 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21684790 FUHO jtl: Therapeutic Innovation & Regulatory Science issn: 21684790 maglogo: N pubinfo: dt: Jan2025 vid: 59 iid: 1 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 182099783 180515432 182099783 182099783 10.1007/s43441-024-00701-x 182099783 ppf: 63 ppct: 8 formats: tig: atl: Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs. aug: au: Yoshiura, Hiromu Kawata, Yayoi Sengoku, Shintaro affil: https://ror.org/0112mx960 Department of Innovation Science, School of Environment and Society, Tokyo Institute of Technology, Tokyo, Japan sug: subj: Diffusion of Innovation Government Regulations Drug Development Legislation and Jurisprudence Manufacturing Industry Legislation and Jurisprudence Organizational Culture Antibodies Therapeutic Use Antibodies, Monoclonal Therapeutic Use Human Funding Source PubMed Interinstitutional Relations Technology, Medical Collaboration Descriptive Statistics ab: 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. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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