Understanding Freezing, Annealing, Primary and Secondary Drying in the Freeze-Drying Process
Duration: 60 Minutes
This seminar will cover the freezing, annealing, primary drying and secondary drying steps of a lyophilization process. As each of these steps can affect both the chemical and physical integrity of freeze-dried products, it is important to thoroughly understand the scientific principles behind each step, and how to apply them when developing an optimized lyophilization cycle. Additionally, understanding these principles and how then affect the product allows the development scientist to better troubleshoot failed products and or cycles.
Why Should you Attend:
Understanding the different steps in a lyophilization process and how they can affect the physical and chemical integrity of products is critical to achieve an optimized process that consistently produces quality products that meet established specifications. Additionally, when products or processes fail, understanding and correcting the problem is a much easier task if one understands these principles, and how they can affect product and process.
As formulations get more complex due to the higher complexity of the biologically based active ingredients (monoclonal antibodies, vaccines, etc.), it becomes imperative to understand how each of the different phases of a lyophilization cycle can impact the molecules stability. Many of these complex formulations for the biologically based active ingredients have the potential to form metastable systems during the lyophilization process due to the addition of the combination of amorphous stabilizing and crystalline bulking agents. Understanding why and when these types of systems form is critical in understanding when and how an annealing step should be added to a lyophilization cycle.
This webinar will start off with a discussion of the thermal properties of a formulated product (the first step in any well designed and understood process and formulation). Next, the discussion will turn towards understanding the theory behind each step, and how to apply these principles based on the thermal properties of each formulation. By understanding and carefully designing each step of a lyophilization process, the person designing the cycle can be assured that an optimized cycle has been developed that will produce product with consistently good , long term physical and chemical integrity.
Objectives of the Presentation:
- Thermal properties of formulated products
- Theory and practice of freezing protocols
- Theory and practice of annealing protocols
- Theory and practice of primary drying protocols
- Theory and practice of secondary drying protocols
- Tying the different steps together into a complete lyophilization process.
Who can Benefit:
- Understanding the thermal properties of a formulated product
- Understanding how different freezing protocols affect the physical stability of sensitive molecules
- Understanding when and why an annealing step is needed
- Understanding and applying the principles to get optimized primary and secondary drying protocols.
This webinar will provide valuable assistance to those companies involved in the handling of lyophilized products including injectable drug products, bulk dried products, diagnostics, and freeze-dried foods.
Live Session - How it works
- Quality Control Scientists
- Development Scientists
- Production Management
- Quality Assurance.
Recorded Session - How it works
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