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Pharmaceutical Technology

Pharmaceutical Technology-11-01-2004
Volume2004 Supplement
Issue 8

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.

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