Technology Transfer of the Bulk Drug Process and First Manufacture

TECHNOLOGY TRANSFER OF THE BULK DRUG PROCESS AND FIRST MANUFACTURE 

Technology transfer has become the term that more appropriately describes all the events associated with the first manufacture of a new bulk drug (or for that matter, of any new product with its own distinct process for manufacture. 

In its broadest definition, so as to capture all the activities for its execution, the scope of bulk drug technology transfer 

Early stage (around the time the new drug candidate enters development)  

Process development/scale-up Joint manufacturing planning 

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