January 13 - 17, 2014
Renaissance Hotel and Palm Springs Convention Center Palm Springs, California

A Community Dedicated to the
Evolving Field and Future of Biotherapeutics
Archived Content

Lyophilization and Emerging Drying Technologies


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FRIDAY, JANUARY 13

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

 

CYCLE DEVELOPMENT

8:15 Chairperson's Opening Remarks
Taylor N. Thompson, President, Millrock Technology

8:20 Vial-to-Vial Variation for Freeze-Dried Products during Primary Drying: A New Way to Approach Design Space

Robin Bogner, R.Ph., Ph.D., Associate Professor, Department of Pharmaceutical Sciences, University of Connecticut

It is current practice to develop a design space by defining the optimum operating conditions and setting conservative operating ranges to assure "no failures." However, even a Six Sigma strategy predicts 3.4 defects/million.  A risk-based design space approach has been developed by propagating the variances in product resistance and heat transfer coefficient through to the variation in primary drying time and maximum product temperature.  During scale-up, the design space changes in a complex way that can now be understood through process modeling.

8:50 Effect of Drying High-Concentration Protein Formulation At, Above and Below Tg'

Sajal Patel, Ph.D., Scientist, Biopharmaceutical Development, MedImmune; Co-Author:  Swapnil Pansare, R&D Associate, Biopharmaceutical Development, MedImmune

Traditionally, amorphous systems are freeze-dried 2-3°C below Tg' to avoid product collapse which may further effect product stability via high residual water content. Additionally, a collapsed vial is simply rejected because of lack of elegance. For low concentration protein formulations, the collapse temperature is within 1-2C of Tg' and hence the general rule of thumb is to dry below Tg'. However, for high concentration (≥100mg/mL) protein formulations the difference between Tg' and Tc could be as high as 10-14°C with Tc being higher than Tg'. This opens up an opportunity to dry the product significantly above Tg'. Nonetheless, the question remains as to what happens to the cake structure, product stability, reconstitution time and percentage of residual water – the objective of this research.

9:20 Freeze Drying Above Collapse Temperature

Gerhard Winter, Ph.D., Professor, Chair of Pharmaceutical Technology and Biopharmaceutics, LMU München

The standard technology to achieve storage stable dosage for very unstable biotech drugs is freeze drying. It will be shown that leaving the dogmatic desire for elegant cakes can not only shorten long drying time and thereby reduce costs but may surprisingly even lead to very stable products, eventually even more stable than conventional lyophilisates.

Sponsored by
Millrock 
9:50 Innovations for Simplifying Freeze Drying Protocol Development and Optimization
Matthew Ling, Manager, Research & Development, Millrock Technology, Inc.
This topic will introduce a cycle development method from a totally different perspective. It will be a great value for both new people to the field and freeze drying experts. Specifically, it will present new methods to assist freeze drying cycle development, will share a novel case study on close loop freeze drying control, and will discuss new trends and technology in freeze drying equipment.

10:05 Networking Coffee Break in the Exhibit Hall with Poster Awards

11:00 Tech Transfer Considerations during Lyophilization of Highly Concentrated Antibody Formulation: Case Studies Describing Scale-Up from Laboratory to Pilot Scale

Akhilesh Bhambhani, Ph.D., Senior Research Chemist, Vaccine Drug Product Development and New Technology, Merck & Co., Inc.

Case studies describing challenges and considerations during the scale-up and tech transfer of lyophilized antibody formulations are presented. Lessons learned and practical considerations from two different case studies (mAb @ 25 mg/ml and 100 mg/ml, respectively) are summarized with specific focus on reconstitution time, container/closure and facility-centered transfer.

11:30 Simulations of Vapor Flow in Freeze-Drying: Does Convection Matter in Scale-Up?

Arnab Ganguly, School of Aeronautics and Astronautics, Purdue University

Co-Authors:  Steven L. Nail,  Baxter BioPharma Solutions, Baxter Healthcare Corporation, and Alina A. Alexeenko, School of Aeronautics and Astronautics, Purdue University

12:00 pm Incorporating QbD into the Development and Tech Transfer of a Lyophilized Drug Product

Phuong Nguyen, Ph.D., Scientist, Parenteral Formulation Sciences, Millennium: The Takeda Oncology Company

QbD as described in ICH Q8 creates a framework for evaluating the robustness of a formulation or a process and can guide process understanding.  Pharmaceutical lyophilization is a complex process consisting of at least 3 interconnected stages, with many parameters and scale-up factors that influence the end product quality.  Case studies will be presented exploring the development and tech transfer of the entire lyophilization cycle utilizing QbD elements.

12:30 Close of Morning Session

12:45 Luncheon Presentations (Sponsorship Opportunity Available) or Lunch on Your Own

 

SPRAY DRYING AND EMERGING DRYING TECHNOLOGIES

2:00 Chairperson's Opening Remarks

Edward Trappler, President, Lyophilization Technology, Inc.

2:05 Techniques for Assessing the Effects of Ice Nucleation Temperature on Primary Drying Rate and Final Cake Morphology

Chris Heynes, Senior Research Associate, Pharmaceutical Processing and Technology Development, Genentech, Inc.

 

          Sponsored by
LyophilizationTechnologies
2:35 Regulatory Science Aspects Addressing ICH Q8 and FDA Process Validation Guidance Directives for Development Through Commercial Manufacturing for Lyophilized Products and Processing
Edward Trappler, President, Lyophilization Technology, Inc.
Existing ICH guidelines and the recent FDA Guideline to Process Validation places greater focus on the product life cycle, starting with development.  Considerations to applying principles of the ICH and FDA Guidelines and applying good scientific principles will be presented.


3:05 Can We Count on Spray-Drying as a Real Alternative for Freeze-Drying?
Evgenyi Shalaev, Ph.D., Associate Research Fellow, Pharmaceutical Development, Pfizer
While freeze-drying is an important manufacturing method to produce a wide range of pharmaceutical and biotech products, it is commonly associated with high operational cost, inefficient use of energy, and high capital investments. Therefore, there are on-going efforts to find alternative processing methods to reduce cost of goods, without compromising product quality. Spray-drying has been often considered as the leading freeze-drying alternative. However, there are multiple hurdles preventing implementing spray-drying for aseptic manufacture. The presentation overviews scientific, technical, and logistic challenges.  

3:35 End of Conference


Day 1 | Day 2 | Download Brochure


Links to Companion Meetings

Pipeline 1

Protein-Device Combinations

Optimizing Biologics Formulation Development

Protein Aggregation and Emerging Analytical Tools



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      Premier Sponsors: 

EMD Millipore 

 Novozymes (white) 

PerkinElmer NEW 2009 

 Protein Simple  

  

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Training Seminars 

Mon-Tues, January 13-14 

Biologics Formulation and Delivery  

 


Buzz Sessions
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