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 |
| Published: |
Springer Nature
Jan2025
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| Online Access: | View this record in EBSCOhost |