Day 1 - Conference Agenda

Session 1 Current Regulatory Considerations
Session 2 Formulation Strategies and designs
Session 3 PAT Tools & QbD
Session 4 Morning Coffee and Networking Break
Session 5 Scale up and Tech Transfer
Session 6 Cycle Developments & Optimization
Session 7 Lunch Break
Session 8 Freeze drying of Proteins, Special Formulations
Session 9 New Technologies and Development
Session 10 Product Control - In Process, Visual Inspection, Container Closure Integrity
Session 11 Afternoon Coffee and Networking Break
Session 12 Manufacturing – Loading/Unloading of FD, Cleaning & Sterilization, Equipments
Session 13 Validation Maintenance – Self Temperature, Calibration of Probes, testing

Day 2 - Hands-on Training

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Mostafa Nakach

Head of Pharmaceutical Engineer, Sanofi Aventis

The workshop will outline the following topics:

  • General Introduction to Freeze Drying
  • Freezing understanding :Fundamentals of Ice crystallization
    • Cryoconcentration & consequences/risks
    • Tg’ concept
    • Excipient crystallization
    • Phase separations
    • Formulation :Excipients: Bulking agents, buffers, Stabilizers
    • Amorphous mixes- Gordon taylor
    • Product PropertiesDefects in freeze drying
    • Water sorption & Stability of amorphous phases
  • Primary drying
    • Fundamentals
    • Detailed heat transfer
    • Detailed mass transfer
    • Coupling parameters
    • Scale-up considerations and associated issues
  • Secondary drying kinetics
  • Practical advice
  • Quality by design

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Yossi Shapira

BSc in Tel Aviv University – Israel

Topic: experience sharing : product to product lyophilizer preparation

Lyophilization is a critical operation which is done while vials are semi opened. The process is vulnerable by means of sterility, by means of contamination, sealing integrity etc. it seems that we are discussing lyophilization process a lot, but neglecting all other operations which are required to prepare the commercial lyophilizer, the critical machine, to handle new product.

  • Clean In Place
  • Sterlize in Pace
  • Vent filter integrity
  • Construction integrity

This Workshop will be based on lot of real case studies : Let’s share experience, let’s review what you perform in lab/plant. Attendants might share/ bring their processes printout and trends. We shall try to review it while leading lyophilizers vendors to design and to give us what we need accordingly. Lyophilizers vendors are not expert in your processes or products. This is a great opportunity to share and collaborate : customers and vendors. experience

Download Agenda to know more

Download Agenda

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