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Demand for efficient tech transfer, as well as compliant on-time delivery, is rising.
Biologic manufacturing has seen numerous developments that have helped reduce production process timelines, with the industry striving to standardize and simplify manufacturing processes. By developing comprehensive strategies that include deep knowledge of the regulatory arena, specialized contract development and manufacturing organizations (CDMOs) can streamline workflows, reduce production costs, and increase efficiency. As growing numbers of biotechs seek support from expert CDMOs, efforts must be made to further streamline timelines with a sharp focus on the technology transfer process.
Jinhyeok Jeong is senior director of Drug Product Inspection and Packaging, and John Thomas is senior director of Drug Product MSAT; both at Samsung Biologics.
eBook: Manufacturing and Facilities 2023
When referring to this article, please cite it as Jeong, J.; Thomas, J. Tech Transfer and Regulatory Compliance. BioPharm International’s Manufacturing and Facilities 2023 eBook. November 2023.