ComplianceOnline, Online Event
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 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.
Date: October 10, 2012
Time: 10:00 AM-11:30 AM PDT
Cost: $249 per attendee per computer terminal
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||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.