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Quality by Design

Cell & Gene Therapy

Cell & Gene Therapies: is Quality by Design ready for it?

In this blogpost, we want to make you think about the application of the Quality By Design for Cell & Gene Therapies. Over the past century, lifecycle management of biotechnology products and biopharmaceutical industry has been founded on principles from the pharmaceutical small-molecule industry. But are they suitable for it? Read more…

By 4TE Team, 2 yearsJuly 16, 2021 ago
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Category
  • Bioequivalence studies (1)
  • Biossimilarity Studies (5)
  • Cell & Gene Therapy (4)
  • Comparability Studies (7)
  • Computer Software Assurance (3)
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  • Continuous Manufacturing (7)
  • CPV Programs development (7)
  • Custom-made Software (1)
  • Development of Quality by Design Frameworks (9)
  • Digital Twin (2)
  • End-to-End Process Troubleshooting (1)
  • Knowledge Management (2)
  • News (21)
  • PAT Integration (4)
  • Process Digitalisation (3)
  • Process Scale-up (3)
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  • QRM Summit (1)
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    • Medical Cannabis (1)
  • Quality Risk Management Digitalisation (13)
  • Risk Management Digitalisation (5)
  • Risk Management Process Optimisation (3)
  • Risk Management Process Optimization (6)
  • Root-Cause Analysis (2)
  • Uncategorized (1)
  • Validation (1)
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4Tune Engineering provides 4.0 Intelligent & Integrated solutions to support Pharma and Biopharma Industries' Digital Transformation. Focused on operational excellence, we assist companies improve decisively the entire life cycle of their products and processes. Founded in 2004 with offices in Lisbon and São Paulo.




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