3 hr Virtual Seminar - Lyophilization Technology: Freeze and annealing, primary and secondary drying, process scale-up and troubleshooting failed products or cycles as part of a cGMP compliant process for lyophilization cycle development and optimization

Why Should You Attend :

This seminar will begin with a discussion on freezing and annealing as part of a lyophilization cycle.  It has been shown that how a sample is frozen prior to freeze-drying can have a dramatic impact on how that product dries during primary and secondary drying.  Additionally, for large, biologically based molecules, the freezing segment of the cycle can have a large impact on the stability of those molecules as well.

After freezing, the discussion will turn to the primary and secondary drying processes, and how they are affected by the engineering principles of heat and mass transfer.  Using the principles just presented, the discussion will turn to scale-up and cycle transfer issues, which have traditionally been some of the most challenging issues in getting a product up to a full-scale manufacturing process.

Finally the discussion will finish with several case studies in fail products due to poor formulations or poor lyophilization cycles.  This will be an open discussion with the attendees to troubleshoot, diagnose, and correct failed batches of product.

Areas Covered in the Seminar :

• Freezing vs. vapor pressure
• Ice nucleation and ice crystal growth
• Effects of ice crystal particle size
• Eutectic and/or glass formation
• Annealing theory and techniques
• Heat transfer theory
• Mass transfer theory
• Conduction, convection, and radiation
• Critical parameters in scale-up and cycle transfer
• Scale-up strategy
• Mapping studies
• Dryer configuration
• Determining and preventing choked flow conditions
• Open discussion on case studies
• Open general discussion on freeze-drying

Learning Objectives :

• Identifying and understanding the different stages of a freeze-drying process.
• Understanding heat and mass transfer operations and how to optimize these for best results.
• Understanding the critical issues in scale-up or cycle transfer.
• Understanding the phenomenon of “choked flow” and how to prevent it from happening.
• Understanding how to correctly identify a failed product or cycle, and how to correctly fix the problem so that it does not occur again.

Who Will Benefit :

This webinar will provide valuable assistance to those companies involved developing formulations and lyophilization cycles, or in lyophilization product manufacturing.

• 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 :

Many problems have arisen in the past when designing lyophilization cycles because this process was more of an art than a science, and cycles were designed based on a “trial and error” approach.   By understanding and applying the theory of the different phases of a lyophilization cycle, it makes the process easier to understand, design, and troubleshoot should problems arise.

Additionally, the Regulatory bodies are expecting to see that the innovator understands the science behind the cycle and has developed it accordingly.  Companies that do not understand the scientific principles behind their cycles run the risk of being delayed in getting their products approved and on the market, which can have a dramatic impact on their profit margin.

By far, one of the most difficult tasks in getting a lyophilized product from the laboratory bench to the commercial freeze-dryer is scale-up, or cycle transfer.  Problems that typically arise from scale up issues include shattered vials, meltback, collapse, higher residual moisture levels, and decreased shelf life.  By taking the time to identify the critical issues for a particular product and understanding equipment differences, the development scientist or engineer has a much higher chance of successfully producing consistent, quality, product whether it is being dried in a development-scale dryer, a Clinical-scale dryer, or a large commercial-scale dryer.

Finally, several case studies of failed products will be presented to the attendees and left for open discussion to identify and correct the failures.  By understanding and applying the principles discussed in this segment and Part 1, troubleshooting, failure identification, and correcting problems are a much simpler task, reducing lost time and lost revenue.

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