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


J. JEFF SCHWEGMAN

CEO - AB Biotechnologies

Dr. J. Jeff Schwegman is the Founder and CEO of AB BioTechnologies where he manages the day to day operations of the company. Dr. Schwegman received his Ph.D. from Purdue University in 2003 and returned to Bloomington where he worked at Baxter Pharmaceutical Solutions as a Research Scientist in the Pharmaceutical Development group. He specializes in speaking and consulting in parenteral preformulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules.In November 2005, he left Baxter and formed a life science company which specialized in developing new formulations and manufacturing processes for parenteral products. In February 2008, he formed AB BioTechnologies.

The workshop is designed to provide scientists involved in different stages of freeze drying, from development at laboratory scale to industrial production all aspects of the freeze drying process.

This workshop will cover formulation and lyophilization considerations for a freeze-dried product including:

  • Excipients suitable/unsuitable for lyophilized products
  • Excipient screening studies for formulation design
  • Optimizing the thermal properties through elimination/addition of excipients
  • Small molecule vs. large molecule formulation screening/development
  • Lyophilization cycle development of an optimized formulation
  • Case studies in failed products
  • Scale up and cycle transfer

MOSTAFA NAKACH

Sanofi Aventis - Head of Pharmaceutical Engineering

Mostafa Nakach is PhD from Toulouse University. He has prepared his thesis on stabilization and production of nanocrystalline suspension. He is also Master 2 graduate from Paris-sud 11 university in Pharmacotechnie and Biopharmacy and Pharmaceutical engineer from Ecole des Mines d’Albi . Mostafa is working within sanofi group since 29 years. His current position is a head of pharmaceutical engineering section within pharmaceutical science operations.

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

Download Agenda to know more

Download Agenda

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