Challenging "The Process is the Product": Clarifying the Role of Information Technology in Biopharmaceutical Process Development
The author argues that information technology solutions will play a major part in confirming-by experimental and statistical validation-that bioprocesses may be interchangeable and therefore generic. The bioprocessing ANDA will define both in-house and contract manufacturing.
Articles in this issue
Named Anchor Problem
Why Search Matters: Information Retrieval in the Pharmaceutical Industry
Integrated Information Management Approach to Drug Substance and Drug Product Scale-Up
Challenging "The Process is the Product": Clarifying the Role of Information Technology in Biopharmaceutical Process Development
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