Freeze Drying in the Pharmaceutical, Biological and Food industry

Why Should You Attend:

This session will start with an introduction to thermal characterization including differential scanning calorimetry (DSC) and freeze-dry microscopy (FDM) and how the information gained from these techniques can be used as the foundation for optimized formulation and cycle design.

Next, we will discuss, in detail, the process of designing the freezing, primary, annealing (if used), and secondary drying protocols for the cycle. In each case, the process will be broken down to understand the correct choice of the different controllable lyopohilizer parameters including shelf temperature, chamber pressure, and hold times. Also discussed, will be some of the specialized tools that can be used to aid the development scientist in cycle development including, the sample thief, the Pirani gauge, and thermocouples.

Learning Objectives:

• Learning how to interpret a lyophilization cycle chart.
• Understanding formulation issues in regards to lyophilized products.
• Developing optimal conditions for freezing, primary, and secondary drying.
• Distinguish between amorphous and crystalline components and how they affect cycle design.
• Understanding the need and techniques of characterizing the dried solids.

Areas Covered in the Seminar:

• Thermal characterization including DSC and FDM.
• Understanding the effects of working with crystalline vs. amorphous components.
• The problem with working with a metastable glassy system and the use of annealing to correct this problem.
• Important issues in formulations to be freeze-dried.
• Determining optimal shelf temperatures for the freezing step.
• Determining optimal shelf temperatures and chamber pressures for the primary drying step.
• Determining optimal shelf temperatures and chamber pressures for the secondary drying step.
• Characterization of the finished lyophilized product.

Who Will Benefit:

This webinar will provide valuable assistance to those companies involved in the handling of powders, lyophilized products, solid pharmaceutical dosage forms, and dried foods. Personnel who will benefit include:

• Quality Control Scientists
• Food 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:

Optimized formulation and lyophilization cycle development can be an extremely difficult and daunting task for the scientist that is unskilled or under skilled in the process. This is becoming even more prevalent as many of the molecules coming out of discovery are more complex, unstable, and require a very specific, multi component formulation to impart not only good chemical stability and physical stability to the active ingredient, but also good physical stability to the dried solids themselves. Freeze-drying in the food industry can be even more complex as the uniformity of the products will change due to being natural products. Unfortunately, many of the molecules that are used to help stabilize the chemical and physical stability of the product of interest, impart poor physical stability to the dried solids and can make lyophilization cycle design difficult. The development scientist who understands and can apply these principles, will be much better equipped to develop robust cycles that can be used to produce quality products consistently, in the shortest amount of time possible, saving time and money.

In the past, a “trial and error” approach was routinely used as the means of formulation and design, often resulting in products that were substandard or cycles that were prohibitively long and expensive. By taking the time to characterize the thermal properties of each product, and understanding how to use this information correctly during each phase of formulation and cycle development, the development scientist can ensure that a quality product, meeting both chemical and physical quality specifications can be produced in the shortest amount of time possible.

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