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Bioprocess and Analytical Method Development

4-week online course | 2 hours per week

4 March - 8 April 2019

Online Academy

Week 1, Module 1:

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Introduction to bioprocessing and biomolecules used as biopharmaceuticals
  • Important definitions
  • Which biomolecules are we trying to produce?
  • How to analyse and characterize biopharmaceuticals?
  • Overview of representative industrial production processes based on different expression systems

Week 1, Module 2:

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Main steps of the production process: Part 1 - Cell constructs & Upstream processing
  • Step by step guide to technologies used for
    • Cloning
    • Cell banking
    • Characterisation
  •  Upstream processing from cell inoculum to first product expressed

Week 2, Module 3:

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Main steps of the production process: Part 2 - Product harvesting, purification and formulation
  • Advanced harvesting technologies
  • Main purification steps and objectives
  • Connection of unit operations to reach an integrated downstream process
  • Product formulation – what to consider?

Week 2, Module 4:

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Further investigating upstream, downstream and formulation
  • Formats and current technologies
  • Scale-up and process transfer

Week 3, Module 5:

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Process and analytical method development activities
  • From early clone screening up to process robustness studies
  • Analytical methods used for process monitoring, control and release

Week 3, Module 6:

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Viral safety aspects
  • What do I need to do and when?
  • Cell Lines
  • Raw Materials & Production Environment
  • Process
  • Viral Clearance Studies

Week 4, Module 7:

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Main quality & regulatory requirements
  • Comparability studies
  • Equipment qualification
  • Stability studies
  • Risk assessments
  • Process, cleaning, analytical method validations