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Informa
08:30 - 09:00 30 mins
Modern CMC Regulatory Strategies and Insights – from Concept to Approval
Registration and Morning Coffee
08:30 - 09:00 30 mins
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
Registration and Morning Coffee
09:00 - 09:05 5 mins
Modern CMC Regulatory Strategies and Insights – from Concept to Approval
Chairperson's Opening Remarks
  • Margit Holzer - Scientific Director and Exclusive Consultant, Ypso-Facto, France
more
09:00 - 09:05 5 mins
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
Chairperson's Opening Remarks
09:05 - 13:05 240 mins
Modern CMC Regulatory Strategies and Insights – from Concept to Approval
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
  • Margit Holzer - Scientific Director and Exclusive Consultant, Ypso-Facto, France
more
  • Definitions
  • Regulatory background
  • Overview of Bioprocess Controls for USP and DSP – What & Why & When to measure & control
  • Important requirements on process monitoring & control loops – from sampling, measuring, visualization, software, equipment and feed-back or feed-forward controls
  • Measuring points, frequency, data treatment and storage
  • Testing to be performed during development, scale-up, validation and routine production, illustrated on continuous chromatography
  • Control hierarchies
  • Routine operation, cleaning, calibration, maintenance
  • What to do in case of out of control situations?
  • Main differences between batch and continuous bioprocess control
  • Case studies:
    • Perfusion monitoring & control strategy
    • Mab DSP monitoring & control strategy
09:05 - 13:05 240 mins
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
Modern CMC Regulatory Strategies and Insights – from Concept to Approval
more

This session provides an overview of modern regulatory CMC strategies which may be selectively applied for a cross range of product classes (e.g. biopharmaceuticals, biologics, advanced therapy medicinal products, biosimilars, vaccines) and how this can be used in consideration for objectively reducing the overall time and cost. This ‘interactive’ session will focus on biopharmaceuticals, biologics, ATMPs, vaccines and biosimilars. Collective team discussions, whiteboard exemplification and workthroughs will be made on key topic points.

13:05 - 17:20 255 mins
Site Visit to the Biotech Training Facility, Leiden
  • Ronald Kompier - Managing Director , Biotech Training Facility, The Netherlands
  • Rebekah Bikker - Marketing and Commercial Manager, Biotech Training Facility
  • Judith van der Zwan - Customer Relations Manager, Biotech Training Facility
more

Biotech Training Facility (BTF) is a unique training center where people are trained in a real-life pharmaceutical production facility. Good Manufacturing Practices, production operations, process and analytical validations are examples of training topics. The courses contain hands-on training and are key for among others production operators, quality assurance officers, lab technician and maintenance engineers. The facility is also being used as a pilot plant for testing equipment and training on company specific production processes and analytical methods. Biotech Training Facility is completely equipped with cleanrooms, laboratories and a technical area with easily accessible utilities.

Showing of Streams
13:05 - 17:20

Site Visit to the Biotech Training Facility, Leiden

Biotech Training Facility (BTF) is a unique training center where people are trained in a real-life pharmaceutical production facility. Good Manufacturing Practices, production operations, process and analytical validations are examples of training topics. The courses contain hands-on training and are key for among others production operators, quality assurance officers, lab technician and maintenance engineers. The facility is also being used as a pilot plant for testing equipment and training on company specific production processes and analytical methods. Biotech Training Facility is completely equipped with cleanrooms, laboratories and a technical area with easily accessible utilities.

  • Ronald Kompier - Managing Director , Biotech Training Facility, The Netherlands
  • Rebekah Bikker - Marketing and Commercial Manager, Biotech Training Facility
  • Judith van der Zwan - Customer Relations Manager, Biotech Training Facility
more