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Abstract

A new framework has been developed to provide guidance for cultivating a pragmatic and proactive culture of technology transfer within the biopharmaceutical contract manufacturing (CM) sector. A review of industry practise was performed, and survey and interview feedback from contract manufacturers and their customers was obtained. The research summarised in this paper describes current experiences of technology transfer in biopharmaceutical contract manufacturing of those working in the industry and investigates the factors currently being experienced that lead to transfer challenges, project delays and difficulties faced by the contract manufacturing organisation (CMO) and customer. The framework and associated maturity assessment model provide an opportunity for both CMO and customer to adopt a culture that encourages shared ownership, managed expectations and more efficient transfer processes that address the demands of current biopharmaceutical contract manufacturing

DOI

https://doi.org/10.21427/rqw0-na70

Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 4.0 License.

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