Challenging "The Process is the Product": Clarifying the Role of Information Technology in Biopharmaceutical Process Development

Pharmaceutical Technology, Pharmaceutical Technology-11-01-2004, Volume 2004 Supplement, Issue 8

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.