Route Design is the first step in the strategic development process for manufacture of a new active pharmaceutical ingredient (API). Numerous benefits can be realised for the project and the broader performance of the company. We present an appreciation of some of the potential challenges and describe the principles and practices that have shaped the Route Design culture within AstraZeneca. This is exemplified with case histories and we describe some of the activities that have supported our scientists and the simple messages used to educate the broader organisation.
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http://dx.doi.org/10.1016/j.bmc.2018.06.006 | DOI Listing |
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