Kimberly Vukovinsky

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Vincent McCurdy1
Jonathan Coffman1
Penny Butterell1
Mary am Ende1
1Vincent McCurdy
1Jonathan Coffman
1Penny Butterell
1Mary am Ende
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Recent concerns about the applicability of design space boundaries developed on small scale to commercial manufacturing processes have been raised by regulators worldwide. These concerns center around the scalability of unit operations and their corresponding process parameters, and the impact this has on the desired attributes of the drug substance or(More)
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