Program and speakers

Pharma Training Binzen Germany

Day 1 - Tuesday Sep 11th

Introduction to continuous manufacturing platforms and material characterisation

12.30-13.00Registration and lunch buffet
13.00-13.20Welcome and introduction
13.20-14.50Importance of raw material and formulation blend characterization (raw materials and blends)
  • Relevant raw material and blend properties and their characterisation techniques
  • Material property data bases: overview, predictive use and challenges
  • Material variability
  • Impact of material prperties on the behaviour, performance and residence time of screw feeding systems in a CM platform
14.50-15.20Coffee break
15.20-16.00Case study: design space determination of a continuous tablet manufacturing process via wet granulation through empirical process models
16.00-16.45Empirical versus mechanistic modelling of continuous drug product manufacturing processes. Fundamentals - their complimentarity - importance of proper data collection
16.45-17.30Material data base DEMO + Q&A
17.30-17.45Take home messages of the day
19.00Dinner

Day 2 - Wednesday Sep 12th

Modeling and simulation towards design space determination

8.00-8.30Transfer from hotel to TTC + coffee
8.30-8.45Introduction to Day 2
8.45-9.15Current status on feeding and blending modelling
9.15-14.00modeling of continuous manufacturing unit operations
9.15-9.45Twin-screw granulation: collection of high quality data for model development, calibration and validation
9.45-10.30A holistic systems view of drug product manufacture and in-vitro/in-vivo performance - Flow sheet modelling - Generic model + DEMO
10.30-11.00Coffee break
11.00-12.00Twin screw granulation: model development, calibration and validation + DEMO
12.00-13.00Lunch break
13.00-14.00Data collection and modelling of drying and milling in a continuous manufacturing platform + DEMO
14.00-14.45Optimal experimental design (OED)
  • OED vs Design of Experiments (DoE)
  • OED for efficient model calibration and process optimisation for new formulations
  • Uncertainty analysis as essential step in the establishment of the model based Design Space determination for continuous manufacturing processes
14.45-15.35Coffee break and transfer to innovation center
15.35-17.00LIVE DEMOS with continuous process lines including feeding, blending, wet granulation, fluid bed drying, dry milling and integrated PAT sensoring
17.00-17.20Take home messages of the day
19.00Dinner and wine tasting

Day 3 - Thursday Sep 13th

PAT for monitoring and control of continuous manufacturing processes

8.00-8.30Transfer from hotel to TTC + coffee
8.30-8.45Introduction to Day 3
8.45-9.153D modelling of liquid mixing for pharma applications
9.15-9.45PAT for monitoring and control of continuous manufacturing processes for drug products - Prof. Thomas De Beer
  • SPC
  • Traceability
  • F-test
9.45-10.30Experiences and perspectives from industry (Novartis, Glatt, Fette Compacting)
10.30-11.00Coffee break
11.00-12.00Advanced process control of continuous processes for drug products
12.00-13.00Lunch buffet

Speakers

Academic, industry and regulatory experts

  • Prof. Thomas De Beer (Ghent University)
  • Prof. Ingmar Nopens (Ghent University)
  • ir. Jan Verelst (Siemens)
  • Dr. David Slade (PSE)
  • Dr. Anna Novikova (Fette Compacting)
  • Scientists from Glatt
  • Regulatory experts

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View and download programme overview (pdf)


Training event organisers

"Entire picture covered:(flow sheet) modelling, PAT, control, regulatory"
"Great to see theory practically implemented during the DEMO sessions. Good combination of presentations and demonstrations"

Participant feedback 2017

Questions and information:

training@AM-TEAM.com