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Bio-Intermediate

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By: DAVID SAVASTANO

Contributing Editor, Coatings World and Ink World, Coatings World and Ink World Magazine

For biotechnological/biological products, a material produced during a manufacturing process that is not the drug substance but which is critical to the successful production of the drug. A bio-intermediate will generally be quantifiable and specifications will be established to determine the successful completion of the manufacturing step before continuation of the manufacturing process.

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