Confronting the Bioprocessing Challenge

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Biomanufacturing Overview
  • The Production Process
  • Regulatory Considerations
• No Shortfall in Production Capacity
  • Expansion of Manufacturing Capacity
  • Fewer Approvals Than Expected
  • Improved Technologies, Higher Yields
• Upstream Processes: Mammalian Cell Culture Production
  • Mammalian Cell Lines
  • Bioreactor Technology
    • Bioreactor Hardware
    • Microcarriers
    • Disposables
  • Media Formulation
  • Glycosylation
• Downstream Processes: Protein Purifi cation
  • Clarifi cation and Filtration
  • Affi nity Ligands
  • Hydroxyapatite Purifi cation
  • Disposable Purifi cation Devices
• Outlook for Biomanufacturing
  • Manufacturing Options
  • Pushing the Limits of Production
  • Alternative Expression Systems
  • Importance of Disposables

Tables

• 1. Increases in Therapeutic Protein Manufacturing Capacity
• 2. Contract Manufacturers of Recombinant Proteins and Monoclonal Antibodies
• 3. Marketed Therapeutic Monoclonal Antibodies
• 4. Protein Expression Platforms

Figures

• 1. Worldwide Sales of Recombinant Therapeutic Proteins and Therapeutic Monoclonal Antibodies
• 2. General Bioprocessing Scheme
• 3. U.S. Monoclonal Antibody Approvals, 1997-2006