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Cambridge Healthtech Institute’s third annual “Lyophilization & Spray Drying 2010: Strategies for Successful Formulation, Cycle Development and Optimization, Regulatory Compliance, Validation, and Scale Up” covers the latest trends and challenges in lyophilization, spray drying, and foam drying with a focus on: developing a scientifically sound formulation, optimizing the lyophilization process, successful cycle development and process control, strategies for scale-up from R&D to production, vaccine and biologics freeze/thaw and formulation, container/closure systems, and overcoming tech transfer challenges. The conference features novel case studies, in-depth scientific presentations, and poster sessions. Time has been designated for interactive discussions with industry thought leaders during the BuzZ Sessions on Tuesday and panels. It is part 3 of 3 within the “Pipeline 1: Formulating Biologics: Meeting the Challenges” track and is perfect for those new to the field, as well as those who require in-depth analysis of the latest trends, technologies, and techniques.
Thursday, January 14
1:15 Registration for Lyophilization & Spray Drying 2010
1:45 Chairperson’s Opening Remarks
1:50 Recent Advances in the Science and Technology of Freeze Drying: Bio-Stabilization, Process Optimization, and Quality by Design
Michael J. Pikal, Ph.D., Pfizer Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut
We discuss improvements in the understanding of “Biostabilization”, using hGH and an IgG1 monoclonal antibody as examples. We show that one may achieve an enormous improvement in stability over current marketed formulations with alternate but relatively simple formulations. We illustrate the stabilization that results when a dried product is heat treated, or annealed, below its Tg, thus demonstrating that “cooking stabilizes”. We also review “Quality by Design (QbD)” process development, using the “Smart Freeze Dryer” approach, which is now commercial technology designed to optimize a freeze drying process in the first laboratory experiment, and discuss several critical scale-up issues.
2:20 Rapid Freeze-Drying of Amorphous Protein Formulations in the Micro-Collapsed State
Robert Johnson, Ph.D., Principal Scientist, Global Biologics, Pfizer Global R&D
Protein formulations lacking a crystalline bulking agent can take a long time to freeze dry, depending on the cake height, because low shelf temperatures are often chosen to ensure that the product temperature remains below the collapse temperature during primary drying. However, recent research has shown that high shelf temperatures can be employed during primary drying, with little or no danger of collapse even if the product is in the ‘microcollapse’ regime, especially for proteins. This presentation will focus on a study that uses aggressive and conservative freeze-drying conditions for a model protein and the resultant differences in drying characteristics and cake morphology.
2:50 Combined Two-Dimensional FT-IR and Freeze-Drying Microscopy for In Situ Investigation of Protein Stability during Lyophilization
Heiko Schiffter, Ph.D., Brasenose Research Fellow in Biomedical Engineering, Engineering Science, University of Oxford
New focal plane array detector technology in Fourier Transform Infrared (FT-IR) microscopy alters the time frame for sample mapping by several orders of magnitude and permits the simultaneous measurements of thousands of spectra in seconds, compared to single element detectors. All spectra can be spectroscopically evaluated to determine changes in protein secondary structure and build up detailed transient mappings of these changes. In combination with a freeze-drying microscopy stage, this technique allows the in situ investigation of protein stability during each unit operation of the lyophilization cycle as well as ultra small scale formulation development.
3:20 A Practical Approach to Resolving the Nucleation Problem in Lyophilization
Robert Sever, Ph.D., Manager, BioPharma Research & Development, Praxair
It is highly desirable that pharmaceutical development and manufacturing personnel have complete, reproducible control over the operation, scale-up, and transfer of lyophilization processes. This presentation examines the fundamental problem of random nucleation during the freezing step that has historically prevented such control and introduces a practical method for resolving the nucleation problem. Case study results will be presented showing the impact of nucleation behavior on important process and product attributes, including pore size, drying rate, protein aggregation, vial cracking, product uniformity, and cake elegance.
3:35 Networking Refreshment Break in the Exhibit Hall
4:30 Residual Water in Freeze-Dried Materials: Why and How to Control it and at What Levels
Evgenyi Shalaev, Ph.D., Associate Research Fellow, Parenteral Center of Emphasis, Pfizer, Inc.
Control of residual water is essential for stability of proteins, vaccines, and other freeze-dried pharmaceutical and biotech products. The presentation highlights critical issues on water role, including the following: (i) How to choose water content limits? Is “the drier - the better” always the case? (ii) How to control water content during manufacturing and storage of freeze-dried products? (iii) What is the mechanism of water impact on stability of freeze-dried materials, e.g., does water act as a reactant, a plasticizer, or a modifier of medium properties?
5:00 Case Study: Transferring a Bulk Freeze Drying Process from a Glass Container to a Tray
Patrick Boylan, Senior Scientist, GlaxoSmithKline Biologicals
Freeze-drying of bulk product in glass containers introduces several constraints, including reduced shelf utilization, glass breakage, and longer cycle times. Switching to a tray configuration addresses these issues, but also requires a number of significant process changes. This case study describes the process transfer of freeze-drying a bulk product in 1 liter glass bottles to single-use expanded polytetrafluoroethylene (ePTFE) membrane trays. The design and validation of the new lyophilization cycle will be discussed along with results showing a cycle time reduction of more than 60%.
5:30 Utilization of Modeling to Optimize Freeze Drying Processes
Venkat R. Koganti, Ph.D., Senior Scientist, Parenteral Center of Emphasis, Pfizer, Inc.
This talk will focus on utilization of modeling to optimize freeze drying cycles. A brief introduction to different modeling techniques to model the freeze dried cake during lyophilization will be presented. A major amount of time will be spent discussing real-time projects that benefited from utilization of modeling. Both optimization of lyophilization cycles and assessment of robustness of the proposed cycles utilizing models will be discussed.
6:00 Close of Day
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