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DAY ONE
Monday, January 12
7:30am – 6:00pm Registration Open
7:30 Morning Coffee
LYOPHILIZATION FUNDAMENTALS
WORKSHOPS:
Understanding the Basic Concepts and Processes & Physical Characterization and
Materials
8:45 Organizer’s Welcome
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute
.jpg) 9:00
Part I: Lyophilization Fundamentals—Basic Concepts and Principles
Edward H. Trappler, President & Founder, Lyophilization Technology, Inc.
Insight into the lyophilization process is rooted in understanding the basic concepts, underlying theories, as well as mechanism for each process step. An initial overview of freezing, primary and secondary drying, expounding on the principles for each, will focus on each step separately and as an integrated process. “Real-world” examples to illustrate the concepts will be presented. This introductory session covers the fundamental aspects of lyophilization
and provides an understanding of the critical concepts.
An informal and interactive forum, attendees will be able to participate in discussions on:
- Principles and mechanisms
- Critical and key process parameters
- Interdependence of the process steps
- Factors that influence process and product outcome
10:20 Coffee Break
 10:45 Part II: Physical Characterization and Materials
J. Jeff Schwegman, Ph.D., Founder/Chief Executive Officer,
AB BioTechnologies, LLC
Understanding the physical characteristics of the materials in a formulation to be freeze-dried is critical in obtaining a safe and effective product with an extended shelf life. By characterizing these materials prior to designing a lyophilization cycle, the development scientist takes an empirical approach to cycle design as opposed to cycle design based on trial and error. Using this approach, scientifically sound cycles can be developed that are optimized for the individual formulation saving time and money in manufacturing. Additionally, troubleshooting problematic cycles and or formulations is a much easier task when the physical properties of a formulation are known.
Understanding crystalline vs. amorphous vs. mixed systems
- Measuring eutectic melting, glass transition, and collapse temperatures
- Understanding collapse vs. meltback
- Examples of failed products
- Principals of thermal analysis
- Thermal analysis equipment and techniques: DSC, DTA, TEA
- Freeze-dry microscopy equipment and techniques
- Applications of thermal analysis and freeze-dry microscopy techniques for solutions and solids
12:15 Close of Morning Session
12:30 pm Luncheon Workshop (Sponsorship Available) or
Lunch on your Own
LYOPHILIZATION FUNDAMENTALS
WORKSHOPS:
Formulation Development and Process Optimization & Cycle Development and Process Control
 2:30 Chairperson’s Remarks
Miquel Galan, Innovation and R&D Director, Telstar Lyo
2:35 Part III: Developing a Scientifically Sound Formulation and Optimizing the Lyophilization Process
J. Jeff Schwegman, Ph.D., Founder/Chief Executive Officer,
AB BioTechnologies, LLC
Designing an optimized formulation and lyophilization cycle is an arduous task, and has largely been done through a process of trial and error. By characterizing and understanding the thermal properties of the various active ingredients and excipients, the development scientist will be able to develop a formulation that is optimized for stability while still having good thermal properties for freeze-drying. This workshop will walk through the various stages of preformulation, formulation, and process development and will cover in detail how to choose the correct formulation excipients and cycle parameters for drying.
- Conducting a preformulation assessment
- Selecting acceptable formulation components
- Designing buffers and measuring buffer capacity
- Choosing antioxidants, stabilizers, surfactants, bulking agents, complexing agents, and cosolvents
- The theory and practice of biomolecule stabilization
- Conducting infrared analysis of proteins
- Designing an optimized freezing protocol
- Designing an optimized primary drying protocol
- Designing an optimized secondary drying protocol
- Characterizing the final dried formulation
4:05 Refreshment Break
4:30 Key Considerations for Successful Cycle Development and Process Control
Edward H. Trappler, President & Founder, Lyophilization Technology, Inc.
Identifying the final product design, a suitable formulation, knowledge of the thermal properties, and considering the influence of such factors on the process are significant factors for establishing critical process parameters. The impact of different packaging, the formulation, and critical parameters on the behavior during processing as well as the finished product attributes illustrate the interdependence of each. Comparisons of the influences using different examples will be used to illustrate the magnitude of their respective impact. These include:
- Container/closure influence on processing rates
- Solute and concentration effect on rates and residual moisture
- Product response to differences in processing parameters
- Control and variability of critical processing parameters
This session provides an opportunity for open discussions for exploring application of principles and practical aspects, and the resulting outcome for the process and product.
5:30 Welcoming Reception in the Exhibit Hall
7:00 Close of Day
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