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

Published on: 
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.

Related Content:

ManufacturingInformation TechnologyProcess DevelopmentDevelopmentPharmaceutical Technology-11-01-2004
With New Funding, Orbis Medicines to Develop Oral Macrocycles as Alternative to Biologic Drugs
Using Continuous Processes and Automation to Remove Contamination Risk
Takeda Receives Japanese Regulatory Approval for HYQVIA Subcutaneous Injection for Treating Agammaglobulinemia or Hypogammaglobulinemia