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Course description

Key Topics Covered:

Who Should Attend?

Learning Outcomes

Lyophilization technology is continuously evolving and has gained significance due to wide application in Pharmaceutical /Biotechnology drugs that are too unstable to be commercially available as ready-to-use solutions. As more and more products need to be developed as Freeze dried products, it is of outmost significance to learn the science and latest developments on formulation and process development of Freeze-dried products.

This is a 2 day freeze drying course designed to provide practical training on the principles of product formulation and process development to delegates who develop and /or produce lyophilized ( Freeze dried) products in the pharmaceutical, Biopharma, medical device/diagnostic and Biotechnology industry.

This will comprise the following modules:

  1. Introduction: . An overview of the process, equipment and practice of freeze drying. Introduction of the three controllable process variables.
  2.  The Freezing process: .The process of freezing is often taken for granted, inappropriate freezing can lead to degradation which cannot be reversed. Once a product is frozen: nothing can be done other than remove water. Understanding the behaviour of materials during freezing is critical to successful formulation development.
    1. The Physics of freezing:
      • The difference between low temperature and freezing.
      • The stochastic nature of freezing.
      • Nucleation: Kinetics v Thermodynamics.
      • The consequences of nucleation and growth.
    2. The chemistry and biochemistry of freezing.
      • pH effects.
      • Low temperature protein unfolding.
      • Freeze Concentration and its consequences.
      • Non-Arrhenius kinetics.
      • The end point of freezing: Kinetics v Thermodynamics.
  3. The Materials Science of freeze drying.
    1. Amorphous materials.
      • A basic introduction to non-equilibrium, kinetically controlled states.
      • The Glass Transition.
    2. Excipients
      • Physical behaviour of commonly used materials.
      • Bulking agents versus stabilisers.
      • The rational use of crystalline and amorphous materials.
      • Devitrification and stability.
      • The use of mannitol.
    3. Analytical methods in product development
      • Properties to be determined, common techniques.
      • Differential Scanning Calorimetry.
      • Freeze Drying Microscope.
  4. The (Freeze) Drying process.
    1. Primary Drying. The removal of ice by sublimation.
      • The interplay of temperature and pressure.
      • The response of sublimation to the controllable variables.
      • Effects of fill depth and solids content.
      • End Point Determination.
      • Ice Crystal Maturation and Top Down Nucleation as moderators of resistance.
    2. Secondary Drying. The desorption of residual water.
      • Effects of the controllable variables temperature and pressure.
      • Effects of fill depth, solids content and specific surface area.
  5. The Dry product
    1. Analytical methods in QC. Summary of methods.
      • Residual water and phase distribution.
      • The glass transition as a methodology dependent values.
      • Collapse versus true glass transition.
    2. Chemistry in the glassy state.
      • Relaxation and fragility.
      • Reaction rates; relationship to temperature and Tg.
      • Storage Stability.
      • Residual water and the importance of phase distribution.
      • Effect of crystallisation on stability.
      • Trehalose and self stabilising formulations.
  6. Practical Aspects
    1. Scale Up: Economic and Engineering aspects.
    2. Regulatory aspects
    3. Packaging: stopper and vial design.
    4. Stoppers and the transfer of water.
  • Product and Process Developments Aspects in Freeze drying
  • Basic principles relevant to formulation and process development.
  • An overview of the process, equipment and practice of freeze drying.
  • Introduction of the three controllable process variables
  • Different Techniques of Product Characterization and formulation analysis.
  • Use of Differential Scanning Calorimetry and Freeze Drying Microscope.
  • Use of Different excipients and their role in Formulation development.
  • Practical Aspects of Formulation
  • Scale Up: Economic and Engineering aspects.
  • Regulatory aspects
  • Packaging: stopper and vial design.
  • Temperature variations across drier.
  • Stoppers and the transfer of water.
  • Case Histories – application of the theory

Formulation Scientists, Process Technician, Manager & Senior Managers involved in the art and science of Freeze Drying/Lyophilization in the pharmaceutical/BioPharma Industry, both in R&D and Contract Research & Manufacturing, particularly in the following areas

  • Formulation development
  • Process Development
  • Analytical Development
  • Quality control
  • Process and analytical validation
  • Manager, supervisors and Trainers involved in Freeze Drying

Understand Principle and Practice of the Freeze Dying of Pharmaceuticals and Biopharmaceuticals
Importance of Product & Process understanding
Application of principles relevant to formulation and process development.

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Section 1
Final Quiz