Quality by Design characterization of the perfusion culture process for recombinant FVIII

Keyphrases

• Bioreactor Process 33%
• Cell Culture Techniques 66%
• Characterization Studies 33%
• Combined Impact 33%
• Critical Process Parameters 100%
• Critical Quality Attributes 66%
• Culture Process 100%
• Design Concept 33%
• Design of Experiments Approach 33%
• Design Space 66%
• Downscaling 33%
• Factor VIII Activity 33%
• Factorial Design of Experiments 33%
• Individual Impact 33%
• Multifactorial Design 33%
• Operating Parameters 33%
• Perfusion Culture 100%
• Production Temperature 33%
• Quality by Design 100%
• Recombinant Factor VIII 66%
• Recombinant FVIII 100%
• Risk Assessment 33%
• Tyrosine Sulfation 33%

Engineering

• Bioreactor 33%
• Critical Potential 66%
• Design Concept 33%
• Design of Experiments 33%
• Design Space 66%
• Operating Parameter 33%
• Perfusion Culture 100%
• Process Parameter 100%
• Quality Attribute 66%

Chemical Engineering

• Biochemical Reactor 100%