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Sixth Annual
Lyophilization and Emerging Drying Technologies
Formulation, Cycle Development and Optimization, Regulatory Compliance, Validation, and Scale-Up
January 23-24, 2013 
 

  

Day 1 | Day 2Download Pipeline 1 Brochure | Download Formulation and Packaging Flyer 

This annual conference will cover latest trends and challenges in lyophilization, spray drying, foam drying and emerging drying technologies. It will feature in-depth case studies and discussions on developing a scientifically sound formulation, process optimization, vaccine and biologics freeze/thaw and formulation challenges, strategies for scale-up from R&D to production, and selection of container/closure systems. 

TUESDAY, JANUARY 22

Buzz Session Info 

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1:30 pm Conference Registration

2:00 BuzZ Session A (Please visit our website for an up-to-date listing of topics.)

2:45 Refreshment Break in the Exhibit Hall with Poster Awards

3:30 BuzZ Session B (Please visit our website for an up-to-date listing of topics.)

4:15 End of Day


4:15-4:30 Registration for Dinner Short Courses

4:30 – 7:30 Concurrent Dinner Short Courses (SC5-SC9)*


*Separate Registration Required


WEDNESDAY, JANUARY 23

7:30 am Conference Registration and Morning Coffee 

8:15 Chairperson’s Opening Remarks

Edward Trappler, Founder and President, Lyophilization Technology, Inc.


» KEYNOTE PRESENTATION: 

8:20 Advances in Controlled Ice Nucleation

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

While control of ice nucleation during freeze drying was suggested almost two decades ago, it has only been recently that techniques have been sufficiently developed to allow implementation in manufacturing. This presentation will focus on our recent efforts to compare the various techniques available, including depressurization and several variations of the ice fog technique. The natural variation in ice nucleation temperature both in usual laboratory conditions as well as in Class 100 environments will be documented, and the benefits of controlled ice nucleation will be demonstrated, both in minimizing processing time as well as in maximizing product quality for therapeutic proteins.

 

Lyophilized Formulation Development and Protein Stability 

9:00 Mannitol Crystallinity and Stability of IgG in Lyophilized Formulations

Charlie (Xiaolin) Tang, Ph.D., Associate Director, Formulation Development, Regeneron Pharmaceuticals, Inc.

This is a case study on the rationale of using crystalline excipients in lyophilized monoclonal antibody (mAb) formulations. Stability of the mAb in the lyophilized formulation was examined with different ratios of mannitol crystallinity. There was a correlation of the stability with the secondary structure of mAb and molecular mobility in the solid state. The content will have direct application in protein formulation development.

9:30 Formulation Strategies for Successful Spray Drying and Case Studies

Tarun Mandal, Ph.D., McCaffrey/Norwood Endowed Professor of Pharmacy & Director, Center for Nanomedicine & Drug Delivery, College of Pharmacy, Xavier University of Louisiana

In the pharmaceutical industry, spray drying is typically used as a method for removing water or other liquid from a solution or dispersion of drug and/or excipients. We have increased the solubility of poorly soluble drugs 4- to 20-fold by a laboratory spray dryer. These spray dried formulations achieved higher water solubility and bioavailability because of their submicron particles size. We have also prepared low density or hollow particles for pulmonary delivery of pDNA vaccine. Spray drying improved the pulmonary delivery efficiency by reducing the aerodynamic diameter of the particles.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing

10:45 Phase Behavior of Excipients in Lyophilized Formulations: Potential Implications on Product Performance

Raj Suryanarayanan, Ph.D., Professor, Peters Endowed Chair, Department of Pharmaceutics, University of Minnesota

During lyophilization, crystallization of formulation components can occur. Crystallization of buffer components can lead to pronounced pH shifts in the freeze concentrate. Trehalose, a widely used lyoprotectant, can crystallize as a dihydrate when the frozen solution is annealed. The concentration of the active ingredient (typically a protein) as well as the processing conditions (e.g. annealing temperature and time) influenced the physical form of excipients. The formulation components can influence the physical form of one another during the different stages of the freeze-drying cycle.

11:15 Improving the Stability of Live Attenuated Vaccines

Alex Flood, Ph.D., Program Officer, Technology Solutions Global Program, PATH

Stabilizing live attenuated virus vaccines are among the most challenging of all biologicals to stabilize. We investigated 3 drying technologies to improve the stability of influenza vaccines (both subunit and live attenuated) by freeze-drying, spray-drying, and foam-drying. Dramatic improvements (>10 fold) in storage stability and process loss were obtained. While freeze-drying and spray-drying processes provided the best stability improvement of the subunit vaccine, foam-drying yielded superior stability than the other processes for live-attenuated influenza vaccine.

LyophilizationTechnologies11:45 Lyophilization Process Evaluation in Dual Chamber Cartridge Dosage Forms: A Customized Approach to Achieving a Preferred Product Presentation and Processing Flexibility

Michael Thomas, Senior Research Scientist, Operations, Lyophilization Technology, Inc.

Determining an ideal approach to aseptic processing and lyophilization in a dual chamber cartridge presents challenges based on the requirements for a wide variety of potential container/closure configurations. These processing requirements warrant a robust approach to process design. Product and processing characteristics were evaluated using both more conventional and customized cartridge holding systems. Various cartridge/plunger orientations were assessed. Lyophilized material attributes were compared, establishing potential for improved process design and heat transfer afforded by customized cartridge technology.

12:15 pm Close of Morning Session

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

 

Lyophilization Process Development and Scale-Up 

2:00 Chairperson’s Remarks

Charlie (Xiaolin) Tang, Ph.D., Associate Director, Formulation Development, Regeneron Pharmaceuticals, Inc.

2:05 Risk Mitigation in Lyophilization Process Development and Tech Transfer

Mark Yang, Ph.D., Director, Fill Finish Development, Genzyme

Container closure selection and preparation, API availability, formulation, lyophilizer, and robustness of the lyophilization cycle all can affect and directly impede the effort to develop a robust lyophilization process. The common challenges in the lyophilization process development at different development stages and their mitigation strategies, with case studies, will be discussed.

2:35 Lyophilization Cycle Development: Navigating the Path to a Biological Animal Health Vaccine Product

Wanda Isaacson, Senior Principle Scientist, Veterinary Medicine Research and Development, Biological Formulations, Pfizer

The stability of live organisms used in Animal Health Vaccines is dependent on a well defined formulation and a robust lyophilization cycle. Complex stabilizers are combined with crude antigen preparations to formulate vaccines containing multiple organisms. The development of robust lyophilization cycles is essential to preserve the live organisms and provide stability throughout the shelf life of the product. During cycle development, shelf load temperature, freezing rate and temperature, sublimation during primary drying, and secondary drying temperature and duration are evaluated to optimize the lyophilization cycle. For manufacturing, this well defined cycle produces a consistent product using the shortest equipment cycle possible while minimizing scrap and managing production costs.

3:05 Challenges and Considerations for Developing Lyophilized Biopharmaceuticals

Sajal Patel, Ph.D., Scientist, Biopharmaceutical Development, MedImmune

Many biopharmaceuticals are lyophilized in the hopes of improving the shelf life. However, the freeze-drying process itself presents challenges and considerations (both formulation and process) based on protein concentration and presentation, which will be addressed in this talk. Also, the incorporation of QbD elements (design space and PAT) early on during development will be discussed.

Millrock3:35 Beyond Controlled Nucleation

Matthew Ling, Manager, Research & Development, Millrock Technology, Inc.

Compare the results of experiments performed using FreezeBooster™ Controlled Nucleation on varying applications, including containers and varying solid contents.

3:50 Refreshment Break 

SP Scientific4:15 Scale-Up of Controlled Nucleation to a Production Environment

Mark Shon, Vice President, Technology Development, SP Scientific

A major advancement in freeze dryers over the past decade is the ability to control nucleation, using Praxair’s ControLyo TM Nucleation on Demand Technology. Pilot-Scale work shows significant improvements in the process and product, and the potential for significant ROI to the BioPharma industry. To realize this potential, the technology must be implemented at the production scale. This presentation reviews the work that has been done and in progress to develop a controlled nucleation process that can be validated in a production freeze-dryer.

4:45 Lyophilization Process Monitoring Using Tunable Diode Laser Absorption Spectroscopy

Puneet Sharma, Ph.D., Manufacturing Technical Specialist, MSAT, Genentech

A Tunable Diode Laser Absorption Spectroscopy (TDLAS) Sensor measures water vapor concentration and mass flow rates during the lyophilization process, which can be utilized for estimation of product temperature, drying heterogeneity, end point of primary drying and residual moisture content during secondary drying. This talk will discuss some of the applications of TDLAS sensor in lyophilization process monitoring.

5:15 Close of Session

5:30-6:30 Networking Reception in the Exhibit Hall with Poster Viewing

6:30 Close of Day



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