ISPE training at EASE

ISPE Hands-On Biopharmaceutical Manufacturing Facilities and Processes Training

4 5 November 2025
8h30 17h

2-Day Training Event at EASE

4 - 5 NOV 2025 | (EASE) Facility Strasbourg, France

This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion, and adsorptive chromatography. 

Course topics include: Biotechnology basics 

  • Identify and discuss important operating parameters for each bioprocess unit operation and how they impact process performance
  • What parameters are important for process validation
  • Critical factors for developing a viable commercial manufacturing process
  • The attributes of a "good biotech process" for successful manufacturing
  • Process/Facility relationships
  • The impact of single-use systems in bioprocesses 

Additional content will focus on a review of current regulatory guidance impacting process development and execution.

 

information and registration: https://ispe.org/training/ispe-hands-on-training/nov

 

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