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DAY TWO
Tuesday, January 13
7:00am – 6:00pm Registration Open
7:30 Breakfast Workshop (Sponsorship Available)
.jpg) 8:15 Chairperson’s Remarks
Edward H. Trappler, President & Founder, Lyophilization Technology, Inc.
Formulation and Process Design
 8:20 Freeze-drying of Pharmaceuticals: Some Considerations for Formulation and Process Design
Abira Pyne, Ph.D., Senior Scientist, Bioproducts Research and
Development, Eli Lilly and Company
An overview of the basics of formulation and process development for lyophilized formulations for both small molecules and large molecules will be presented. This will include a discussion of rationale choice of excipients based on the physicochemical needs of the molecule being formulated. In addition, the complex interplay of formulation variables and processing conditions and their impact on process design and critical product attributes will be highlighted. Considerations for identification of critical process parameters and proven acceptable ranges for freeze-drying processes during later-stage commercialization activities of drug product will be discussed.
- Rationale of robust formulation design for lyophilized formulations for chemical entities and for large molecules
- Impact of formulation variables and processing conditions on process design
- Basis of identification of critical process parameters and proven acceptable ranges for freeze-drying processes during commercialization
 8:50 Importance of Optimizing and Controlling the
Freezing Stage in the Lyophilization of
Parenteral Pharmaceutical Products
Jinsong Liu, Ph.D., Principal Scientist, Product Development, Abraxis Bioscience
A freezing process is generally the first stage in a freeze-drying cycle. Challenges in development and scale-up of the freezing process have been generally overlooked. Through case studies presented in this talk, the importance of optimizing and controlling the freezing stage in the lyophilization of parenteral pharmaceutical products will be demonstrated:
- Significant impact on product quality (appearance, intervial and intravial uniformity, moisture content, etc.), drying rate and scaling-up potential
- Critical solutions to some troublesome issues, such as vial breakage (even in formulations without mannitol) and cake blow-off (dusting)
- Possible influence on the shelf life of lyophilized products
 9:20 Case Study: Developing a Clinically Acceptable, Lyophilized Placebo for a Protein Therapeutic
Grant Trierweiler, B.S., M.B.A., Staff Scientist II, BioFormulations
Development, Genzyme
Developing a freeze/dried and clinically acceptable placebo is not always a straightforward endeavor. Manufacturing constraints and/or excipients used in formulation, can lead to alternating the placebos makeup and/or developing a new lyophilization cycle. Identifying the risks involved, and engaging the appropriate groups in the development organization is important to accomplish this task.
- Impact of removing the active ingredient on the lyophilization cycle
- Identify acceptable cycle and formulation parameters
- Addressing product quality: Cake appearance and Pharmacy handling
9:50 Coffee Break in the Exhibit Hall
Cycle Development and Optimization
 10:45 Development of Robust Lyophilization Cycle(s) and Product Characterization for Representative Monoclonal Antibodies at Various Doses
Niles Ron, Ph.D., M.B.A., Associate Director, Formulation-Fill-Finish, Seattle Genetics
Tools and techniques for freeze drying cycle development/optimization and robustness assessment, including product characterization, will be discussed via case studies for use of mAbs in oncology. A matrix development approach to cover several doses---in order to provide most flexibility in the clinic in early development phases---will also be illustrated.
- Lyophilization cycle development and optimization
- Assessment of cycle robustness and impact on product
- Acceleration of lyophilized formulation development and reducing time for FIH introduction
 11:15 Case Study: Lyophilization of a Viral-Vectored Vaccine
Roberto DePaz, Ph.D., Senior Development Scientist, AlphaVax, Inc.
The formulation of macromolecules such as viruses and viral vectors is complicated by their inherent complexity. This presents a challenge to worldwide vaccination efforts, especially as demand for vaccine products continues to increase. Most vaccines require sub-ambient storage from the manufacturing site to the administration site through maintenance of the notoriously inefficient and expensive “cold chain.” Lyophilization is a means to improve the stability and commercial viability of vaccine products currently being developed at AlphaVax. This talk will describe the challenges encountered during formulation development and lyophilization cycle development. Specifically:
- Description of the AlphaVax vaccine technology using alphavirus vectors.
- Appreciate the stability challenges encountered with complex macromolecules, using alphavirus vectors as an example.
- How we developed a stable, lyophilized formulation for our alphavirus-based vaccines.
- How we optimized the lyophilization cycle despite the required presence of reported “cycle-unfriendly” stabilizers.
 11:45
Freeze-Dryer Validation: Following GAMP
T.N. Thompson, President, Millrock Technology
12:15 Close of Morning Session
12:30 Luncheon Workshop (Sponsorship Available) or Lunch on your Own
2:00 Chairperson’s Remarks
Abira Pyne, Ph.D., Senior Scientist, Bioproducts Research and Development,
Eli Lilly and Company
Key Considerations and Strategies for Scale-up from R&D to Production
 2:05 Scale-Up Issues During Lyophilization
Shailaja Rambhatla, Ph.D., Senior Research Scientist, Pharmaceutical Development, Centocor Research & Development
A brief overview of the steady state heat and mass transfer theory of lyophilization will be presented. Scale-up Issues relevant to the freeze drying process will also be presented along with specific examples related to Industrial processes. Finally, guidelines to assist freeze drying process development and scale-up will also be discussed.
- Understanding of the fundamentals of heat and mass transfer during freeze drying
- Practical Issues during scale-up of the lyophilization process
- Guidelines for optimization of the freeze drying process
 2:35 A Soft Observer for In-line Residual Moisture Monitoring during Secondary Drying
Miquel Galan, Innovation and Research & Development Director,
Telstar Lyo
This work is focused on monitoring and control of secondary drying stage of freeze-drying of pharmaceuticals in vials, for which industrial prototypes have already been tested; some comparison of the approaches proposed by different authors will be analyzed. Control of residual humidity in the secondary drying step is of utmost relevance for quality control: non-invasive monitoring and control of this step is much more difficult than for primary drying, but, in this case a model-based approach is possible and some results without the need of moisture analysis will be shown.
- Traditional lyophilization process needs a serious qualitative step to adapt to the emerging QbD initiative and in depth analysis helps to gain process knowledge.
- Moisture evolution in industrial processes can be monitored and in-line precise moisture level assurance is possible.
- Process can be optimized from the initial R&D
 3:05 Developing a Scalable, Transferable Lyophilization Process
Thomas Jung, M.S., Senior Director, Market Development, KBI Biopharma, Inc
3:50 Refreshment Break in the Exhibit Hall
4:30 BuzZ Sessions Breakout Roundtable Discussions:
Attendees will join a table with their peers and a moderator to discuss some of the more poignant questions facing the industry. It’s an informal yet informative format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive session and format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
Topic 1: Applying Process Analytical Technology (PAT) to the Lyophilization Processes
Topic 2: Strategies for Scale-up from R&D to Production
Topic 3: Understanding Process Validation, Cleaning Procedures and Maintenance for Lyophilizers
Topic 4: Strategies for Cycle Development and Optimization
Topic 5: Comprehending Regulatory Requirements for Lyophilization Processes and Products & Applying QbD Principles to Lyophilized Drug Products
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5:30 PM Close of Day
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