Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
News|Articles|November 1, 2004
- Pharmaceutical Technology-11-01-2004
- Volume 2004 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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