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.
Freeze-Drying Process
Instructor: Jeff Schwegman
Product ID: 500094
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.
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.
Who can 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.
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  • Use the login details to view recorded webinars.
  • Presentation handouts will also be shared in pdf format.
  • Access to the recording is valid only till 6 months starting from the date of purchase.
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Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Jeff Schwegman, Ph.D. is currently the founder and chief executive officer of AB BioTechnologies (www.ab-biotech.com) where he develops formulations, lyophilization cycles, determines residual moisture by Karl Fischer, and provides thermal characterization studies including freeze-dry microscopy and DSC. 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 BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington Indiana, where he gained experience in analytical, formulation and process development. In 1999 he began graduate study in the Department of Industrial and Physical Pharmacy at Purdue University under the direction of Dr. Steve Nail, where his focus of research involved studying changes in the physical structure of biological molecules during lyophilization.

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 Innovation and Education. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products.
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