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

Protein-Device Combinations


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THURSDAY, JANUARY 12

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

 

Formulating for Pre-Filled Syringes and Combination Products

8:15 Chairperson's Opening Remarks

Michael Roe, P.E., Senior Engineering Consultant, Device/Packaging/Container Manufacturing, Eli Lilly

8:20 Formulation Development of Biologic Products in Prefilled Syringes

Nagarajan "Raja" Thyagarajapuram, Ph.D., Senior Research Scientist, Pharmaceutical Formulations, Eli Lilly & Co.

The FDA office of combination products has advised that a biologic formulation filled in a prefilled syringe is considered as a combination product. There is a heightened regulatory focus to establish formulation compatibility with various prefilled syringe components. This presentation discusses different experimental approaches to systematically characterize interactions between prefilled syringe components and the solution drug product formulation. Challenges due to the high concentration antibody formulations and compatibility with primary prefilled syringe components such as elastomeric plunger, staked stainless steel needle, needle shield rubber and glass will be discussed.

8:50 New Results on Protein-Silicone Oil Interactions

Devendra (Davy) Kalonia, Ph.D., Professor of Pharmaceutics, Department of Pharmaceutical Sciences, University of Connecticut

In this study, we have used Quartz Crystal Microbalance (QCM) to quantitate the adsorption of a protein on silicone oil coated surfaces as a function of protein concentration, pH and ionic strength using a 5 MHz quartz crystal. Protein adsorption isotherms were generated at different solution pH and ionic strengths.  Surface saturation concentrations were selected from adsorption isotherms and used to generate adsorption profiles from pH 3.0 to 9.0, and at ionic strengths of 10 mM and 150 mM. This presentation will discuss our findings and how QCM can be used as a reliable technique to study the binding of proteins to silicone oil coated surfaces.

9:20 Siliconization:  Challenges and Opportunities

Fangdong Yin, Ph.D., Manufacturing Science and Technology, Parenteral Commercialization Technology Center, Research Advisor, Eli Lilly; co-authored by K. Van Scoick, Ph.D., Senior Director, Manufacturing Science and Technology, Global Drug Products, Eli Lilly

Although siliconization has been used in the pharmaceutical industry for more than 50 years, the development of the process for silicone application is largely empirical. Furthermore, the lack of direct, quantitative characterization methods has resulted in a limited understanding of the nature and distribution of the silicone coating on the glass surfaces and the relationship with the component performance.  This presentation will provide a systematic review of the current status of siliconization related to product (primary component and drug-product) and process development, equipment design and manufacturing.  Key challenges and opportunities will be identified and potential solutions will be discussed to promote further development on siliconization among academics and industries (manufacturers of components, equipment and pharmaceutical products).

Sponsored by
Integrity Bio 
9:50 Lyophilized Product Reconstitution and Delivery
Kenlyn Crosby, Director, LyoTip

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

10:45 Case Study of Sustained Release of High-Concentration Biologics (protein, mAbs): Paradigm Shift from a Ferrari to a Corolla

Robin Hwang, Ph.D., Independent Consultant

There are currently a large number of high dosage mAbs drugs under development.  Due to viscosity and stability issues, concentrating the drug volume down to 1mL is not always possible.  The good news is that the subcutaneous (SC) injection is not limited to 1 mL.  Rapid SC injection of 10 mL is possible with hyaluronidase.  Slow SC injection of 10 mL without hyaluronidase is also possible with a patchpump without causing tissue extortion to ease patient concern and pain.  This talk will focus on the development of such an injection device.

11:15 Glide Force Testing of Container/Plunger Systems

Michael Roe, P.E., Senior Engineering Consultant, Device/Packaging/Container Manufacturing, Eli Lilly

The gliding friction of the sealing plunger in syringe and cartridge systems can greatly affect device performance, dose accuracy, and user satisfaction. This presentation will focus on new methods used to verify performance and what tests should be considered in the development of a new container system.    


Special Bridging Presentation between Protein-Device and Lyophilization


11:45 Challenges in Development and Tech Transfer of Lyophilization Processes in Dual Chamber Syringes

Brian Wilbur, Ph.D., Process Development Engineer, Biotherapeutics Pharmaceutical Research & Development, Pfizer

Some of the challenges associated with developing a freeze-dried dosage-form in a dual chamber will be discussed.  Focused on lyophilization, the discussion will include modeling, differences between lab-scale and commercial drying, and creating a design space from robustness studies.

12:15 pm Close of Morning Session

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

1:30 End of Conference


Day 1 | Day 2 | Download Brochure


Links to Companion Meetings

Pipeline 1 

Optimizing Biologics Formulation Development

Lyophilization and Emerging Drying Technologies

Protein Aggregation and Emerging Analytical Tools


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PTK Event APP 
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2014 Brochure Cover 

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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
BuzZ Sessions are facilitated, small-group discussions. Interactive participation leads to problem-solving solutions and future collaborations around focused topics.
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