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7:00 am Conference Registration

7:30 Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

Freeze-Drying in Syringes

8:15 Chairperson’s Opening Remarks

Parag Kolhe, Ph.D., Principal Scientist, Biotherapeutics Pharmaceutical Sciences, Pfizer

8:20 The Impact of Container System on the Optimum Freeze-Drying Process: Contrasting Freeze-Drying in Syringes with Freeze-Drying in Vials

Michael J. Pikal, Ph.D., Pfizer Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut

Sajal Patel, Ph.D., School of Pharmacy, University of Connecticut

This study investigates the differences in freeze-drying behavior between drying in vials and drying in syringe systems. Two different holder systems were used to freeze-dry in syringes: an aluminum (Al) block and a plexiglass holder. In the Al block the heat transfer was via all three modes, with gas conduction being dominant. In the plexiglass holder the heat transfer was mostly via radiation; convection was not involved. When compared to tubing vials, product temperature is lower and hence drying time increases in syringes, but the differences are sensitive to design of the holder system.

9:00 Two Aspects of Container-Closure Interactions with Protein Therapeutics: Interactions of Proteins and Silicone Oils, and Immunogenic Responses to Microparticulate Contaminants

Theodore W. Randolph, Ph.D., Gillespie Professor of Bioengineering, Department of Chemical and Biological Engineering, University of Colorado, Boulder

9:30 Meeting the Challenges in the Commercialization of Parenteral Products and Devices

Fangdong Yin, Ph.D., Research Advisor, Manufacturing Science and Technology, Parenteral Commercialization Technology Center, Eli Lilly

Kurt Van Scoik, Ph.D., Senior Director, Manufacturing Science and Technology, Global Drug Products, Eli Lilly

In this work, commercialization is defined as the process of establishing reliable and sustainable capability and capacity of commercial-scale manufacturing in order to introduce a new product into the market. Challenges in the commercialization of parenteral products and devices in the pharmaceutical industry will be explored and analyzed, including unique ones related to developmental, regulatory, technology and quality/cGMP as well as the common ones related to speed, cost, resources and uncertainty/risks. Potential strategic solutions are proposed to systematically and fundamentally address those challenges.

10:00 Coffee Break, Exhibit and Poster Viewing

Process Design, Control, and Validation

Chairperson: Satoshi Ohtake, Ph.D., Senior Manager and Senior Scientist, R&D, Aridis Pharmaceuticals

10:45 Process Design and Control in the Freezing Stage: Importance, Challenges and New Advancements

Jinsong Liu, PhD, Principal Scientist, Product Development, Abraxis BioScience

This presentation will bring attention to an important, but often overlooked, aspect in lyophilization of pharmaceuticals – particularly protein/peptide formulations – and summarizes most updated advancements in this area. Topics to be discussed include challenges in understanding and control of the freezing process, impact of freezing on lyophilization cycle development, scale-up and quality of the final product ( including cake appearance, inter-vial and intra-vial uniformity, cake integrity, reconstitution time, container-closure system, in-process and long-term stability) and new technologies for ice-nucleation control in the freezing stage.

11:15 Facility Fit in Lyophilization: Optimizing Tech Transfer and Improving Overall Lyo Line Throughput

Rick Johnston, Ph.D., Executive Co-Director, University of California at Berkeley’s Center for Biopharmaceutical Operations

We outline a more comprehensive approach to the process of integrating new products into existing fill/finish facilities. This approach is based on using Facility Fit principles from the bulk manufacturing process, as well as data from the plant. Using a case study, we discuss how this can both shorten time to market and increase overall throughput.

11:45 Considerations for Scaling-Up Lyophilization Cycles from the Laboratory Scale to the Production Scale and for Transferring Lyophilization Cycles to Different Production Lyophilizers

Willow DiLuzio, Ph.D., Senior Engineer, Formulation Sciences, Millennium: The Takeda Oncology Company

When developing a lyophilization cycle at the laboratory scale, it should be understood how laboratory lyophilizer parameters compare to production scale lyophilizers. By using appropriate scaling factors, laboratory data can be used to accurately predict drying behavior in production lyophilizers. Later in development, laboratory lyophilization data can be combined with production lyophilization data to build a robust model for predicting the product drying behavior in any lyophilizer.

12:15 pm Close of Morning Session

12:30 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

Process Validation Based On QbD

2:00 Chairperson’s Remarks

Danforth Miller, Ph.D., Associate Director, Formulation Sciences, Novartis

2:05 Case Study: Lyophilization Process Validation Based on Quality by Design

Bingquan (Stuart) Wang, Ph.D., Senior Scientist, Bioanalytics and Formulation, Genzyme

This study is to define lyophilization process design space using a systematic QbD approach. The key steps in the approach include qualification of the scale-down model, risk assessment (FMEA), DOE experimental designs and data analysis. This approach is very helpful for a robust process transfer and operation. This is a real world story using QbD Validation approach compared to traditional time-consuming process validation. Experiences on how to gain the design space to support regulatory filing will also be shared.

PROCESS CONSIDERATIONS AND ALTERNATIVES

2:35 The Fundamental Physics of Ice Crystallization

Kenneth G. Libbrecht, Ph.D., Professor of Physics and Physics Executive Officer, California Institute of Technology

I will examine how basic physical processes affect ice crystal growth and morphologies, with an emphasis on lyophilization and other drying technologies. The aim is to better understand molecular growth kinetics, heat and particle diffusion, and other foundational aspects of ice crystallization, leading to better control and modeling.

3:05 Residual Water in Freeze-Dried Materials: Practical Questions and Fundamental Mechanisms

Evgenyi Shalaev, PhD, Assoc Res Fellow, Parenteral Ctr of Emphasis, Pfizer

Control of residual water is essential for stability of proteins, vaccines, and other freeze-dried pharmaceutical and biotech products. There are several critical issues on water role including 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? While the 2010 presentation dealt with the first question, the 2011 presentation will consider two other issues in some detail.

Sponsored by
3:35 Introduction of SP Scientific’s “LyoStar 3”now with Praxair’s ControLyo™ On-Demand Ice Nucleation Technology Inside
Mark Shon, VP Sales and Marketing, SP Scientific
SP Scientific, parent company of VirTis and FTS, and leader in research and clinical scale lyophilizers, continues to improve process control and minimize issues of scale-up with the introduction of the LyoStar 3.   Configured with the most innovative controls and instrumentation, including Smart™ Freeze-Dryer Technology and Praxair’s ControLyo™ On Demand Nucleation Technology, the LyoStar 3 is the ultimate lab scale system for formulations studies, process optimization and scale-up work. 


3:50 Networking Refreshment Break

4:30 Exploring the Collapse Phenomenon during Lyophilization: When Is Collapse Acceptable?

Serguei Tchessalov, Ph.D., Principal Research Scientist II, Pharmaceutical Sciences, Pfizer

Freeze-drying above microscopic collapse temperature, normally performed at aggressive process conditions, could significantly decrease the process time. However, it results in increase of moisture content and reconstitution time and, therefore, for the long time considered to be unacceptable. It has been shown in presentation that for the some materials (process intermediates in particular) the fine balance between economics and acceptable product properties could be found.

5:00 Stabilization of Complex Biologicals by Freeze-Drying Under Unconventional Processing Conditions

Satoshi Ohtake, Ph.D., Senior Manager and Senior Scientist, R&D, Aridis Pharmaceuticals

Very few live attenuated bacteria-based vaccines have become commercially available due to the challenges involved in maintaining their viability during long-term storage. Various attempts were made in improving the storage stability of live attenuated bacteria-based vaccines, including stabilization by freeze drying and spray drying. Unlike these methods, which expose the bacteria to extreme temperatures, foam drying can be conducted at room temperature. Optimization of processing parameters and formulation components, which resulted in a significant enhancement of heat stability of Ty21a vaccine will be discussed.

5:30-6:30 Reception in the Exhibit Hall 

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Links to Companion Meetings

Optimizing Biologics Formulation Development 

Protein-Device Combinations 

Protein Aggregation and Emerging Analytical Tools