The next generation pharma skills you will need in view of continuous manufacturing 11-13 Sep, 2018, Binzen, Germany

Het Pand Ghent

This exclusive pharma training event brings together leading academic, industry and regulatory aspects and combines theory with practical demo's. The first edition of this training event was held in Ghent, Belgium in 2017 and was fully booked.

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
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
9.45-10.30Data collection and management and track and trace
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)
  • Multiple scientists with hands-on expertise
  • Scientists from Glatt (speakers to be confirmed)
  • Regulatory experts (speakers to be confirmed)

Technology Training Center (TTC)

For over 15 years TTC has been expanding knowledge by offering specialized workshops in Binzen and Weimar. Some 100 renowned speakers share their unique technology expertise with the participants. The covered topics are tailored to the needs of solid processing disciplines: granulation, pelletizing, encapsulation and coating technologies for pharmaceutical, fine chemical, food, feed and related industries. The challenging lectures deal with technologies, trends and case studies are combined with practical trainings whenever it’s reasonable. TTC Website

TTC

Hotel and travelling

Hotel and travelling information will be provided very soon. We will notify all our registrants if available.

Sponsoring and exhibition

Exhibition space and exposure for 5 companies is foreseen. Application and info: training@AM-TEAM.com.


Demo's and hands-on activities include:

  • Continuous process lines in action
  • Impact of material properties on CM unit operations
  • Flow sheet modelling of continuous manufacturing
  • Mechanistic modelling of twin-screw granulation, drying and milling

Organised by:

BIOMATH, LPPAT, UGent, AM-TEAM
Pharma training course

Questions and information:

training@AM-TEAM.com