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08:15 - 09:00 45 mins
Registration and Morning Coffee
09:00 - 09:10 10 mins
Chairperson's Opening Remarks
  • Basak Clements - Senior Scientist, Amgen, USA
09:10 - 09:50 40 mins
How to establish a control strategy for a raw material for early phases/clinical trials
  • Jeanet S.K. Kring - Senior Development Scientist, CMC API GMP Material Responsible, Novo Nordisk A/S, Denmark
09:50 - 10:30 40 mins
Current industry perspective on the compliance qualification of Pharmaceutical Incoming Materials
  • Johannes Carteus - Head of Quality for Suppliers & Incoming Materials, GSK Vaccines, Belgium
  • Marjorie Van Robays - Chemicals & Biologicals Hub Manager – Quality for Supplier & Incoming Materials, GSK Vaccines, Belgium
  • Definition of an incoming material versus raw material
  • Qualification of an incoming material versus supplier qualification
  • Risks and variability factors related to pharmaceutical incoming materials
  • Literature review
  • Practical approach to build a robust and comprehensive qualification process
  • Compliance qualification of incoming material in practice
  • Qualification process in a context of a global manufacturing network
10:30 - 11:00 30 mins
Supplier Perspective: Raw Materials Quality Control Strategies
11:00 - 11:30 30 mins
Morning Coffee and Networking
11:30 - 12:10 40 mins
Further characterization of Animal Sera
  • Brian Lewis - President, BL Consulting, Representing ISIA, The Netherlands

The International Serum Industry Association (ISIA) is continuing its efforts to provide better information and tools to aid is risk management for animal derived products in use in vaccine and biotherapeutic manufacturing. The ongoing programs in Traceability, geographic origin, animal age determination and gamma irradiation will be reviewed.

12:10 - 12:50 40 mins
Feedback on the BPOG Raw Material Variability Workstream
  • Basak Clements - Senior Scientist, Amgen, USA
12:50 - 13:20 30 mins
Spotlight presentation
13:20 - 14:30 70 mins
Lunch and Networking
14:30 - 15:50 80 mins
Panel Discussion: Raw Material Variability Control Strategies and Supply Chain Management

Feedback from Industry:

  • Industry strategies for monitoring and controlling raw material variability
  • Impact on productivity and product quality due to difference in critical raw materials
  • What extra process and purification steps are added to ensure raw material quality?
  • Impact of switching suppliers on critical raw material variability
  • Development towards an adaptive control strategy for raw material variability
  • Industry strategies for particle control and managing sub-visible particles

Feedback from Raw Material Suppliers:

  • How are suppliers improving raw material variability/quality and monitoring contamination?
  • Elemental impurity analysis and risk management for trace elements
  • Particle and raw material control strategies
  • Ensuring high quality supply of raw materials for GMP manufacturing
  • Raw material qualification
  • Raw material suppliers – quality of supply: Studies required, how to deal with it
15:50 - 16:20 30 mins
Afternoon Coffee Break
16:20 - 16:25 5 mins
End of Conference Day One