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Biopharmaceutical case studies - download graphic


E-Book: 12 Must-Read Case Studies

Real Engineering Solutions for Biologics in Cell Culture


In manufacturing of biologic drugs using cell cultures, there are wide range engineering challenges across the industry independent of types of therapeutic protein made. This book selectively talks about the most frequently encountered challenges and practical solutions backed-up by scientific concepts and chemical engineering principles. This book helps biopharmaceutical manufacturing engineers to investigate, and troubleshoot such complex manufacturing issues. 

Case studies covered:

  • Mass transfer and shear assessment of bioreactors
  • CO2 control strategies in large-scale cell culture bioreactors
  • Manufacturing process control strategy to drive mammalian cells to undergo metabolic shift
  • Statistical methods to calculate the number of PPQ runs
  • CPV monitoring - Optimization of control chart design by reducing the false alarm rate and nuisance signal
  • Quantitative risk assessment of residual host cell DNA limits to ensure patient safety
  • And many more!