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Understanding Freezing, Annealing, Primary and Secondary Drying in the Freeze-Drying Process

Instructor: J. Jeff Schwegman
Product ID: 702085
  • Duration: 65 Min

recorded version

$249.00
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Training CD

$499.00
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Read Frequently Asked Questions

This webinar on the Freeze-Drying Process will cover the freezing, annealing, primary drying and secondary drying steps of a lyophilization process.

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 attending this training, the participant will be able to understand and carefully design each step of a lyophilization process, and be assured that an optimized cycle has been developed that will produce product with consistently good, long term physical and chemical integrity.

Learning Objectives:

  • 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.

Areas Covered in the Seminar:

  • 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 Will Benefit:

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.

  • Quality Control Scientists
  • Development Scientists
  • Production Management
  • Quality Assurance

Instructor Profile:

J. Jeff Schwegman , Ph.D. is currently the founder and chief executive officer of AB BioTechnologies where he develops formulations and lyophilization cycles. Additionally, Dr. Schwegman specializes in speaking and consulting in parenteral pre-formulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules. He also holds patents and develops new technologies within the lyophilization field.

Dr. Schwegman received his PhD 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. In November 2005, he left Baxter and formed BioConvergence LLC with 3 other founders which specialized in developing new formulations and manufacturing processes for parenteral products. In February 2008, he left BioConvergence, which has become a successful company, to form AB BioTechnologies. He is currently the course Director for a 3-day course called Lyophilization Technology which he teaches through the Center for Professional Advancement. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products. He has also been an active member of AAPS since 2001.

Topic Background:

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.

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