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1:30 pm Conference Registration

2:00 BuzZ Session A 

2:45 Refreshment Break, Exhibit Viewing and Poster Awards

3:30 BuzZ Session B 

4:15 End of Day

4:30 Dinner Short Courses 

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

Commercialization Of Parenteral Products

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

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

10:45 Challenges of Commercializing Devices at a Pharmaceutical Company

Donna French, Ph.D., Senior Director, Device Development, Genentech

Successful commercialization of combination products requires an appreciation of the key elements device development as well as a mindset that the biopharmaceutical and device components should be treated as an integrated system. Human factors engineering, clinical assessments, an understanding of the impact of product properties on device performance, robust training and customer support, and a close partnership with suppliers and are essential for market success and regulatory compliance. Case studies will be used to illustrate the critical importance of these elements of combination product commercialization.

11:15 Interactive Panel: Strategies and Common Challenges: When Do You Bring the Parenteral Device into Development and How Do You Better Integrate Formulation and Device Project Teams?

Danny Chou, Ph.D., Bioprocess Analytical Scientist, Genzyme

Alex Zuyev, Ph.D., Development Fellow, Merck Research Laboratories, Device Development, Merck & Co., Inc.

Beth Hill, Ph.D., Senior Director, Biologics Drug Delivery, Centocor R&D

Charlie Hitscherich, Ph.D., Sr. Director, Biologics Drug Delivery, Biogen Idec, Inc

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

Topics to be discussed include:

• Commercial strategy and marketing considerations: Understanding early in development how commercial reality impacts formulation strategy and designs of container-closure and device
• What are the key challenges for small and large companies/teams?: Having a realistic view of commercial challenges of protein drug delivery
• Design considerations for various systems: Formulator perspective and engineer/device designer perspective
• Injection device considerations: When to develop something new and when to partner with an IP holder

12:15 pm Close of Morning Session

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

Interaction of Protein Formulations with Injection Devices

2:00 Chairperson’s Remarks

Bill Lambert, Ph.D., Senior Vice President, Pharmaceutical Development, Pacira Pharmaceuticals

2:05 Integrating the Examination of Critical Formulation Parameters with the Examination of Critical Syringe Parameters when Developing Protein Formulations in Pre-Filled Syringes

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

When developing a protein formulation for a pre-filled syringe, the container and closure are considered critical elements of the formulation. Traditionally, a protein formulation is selected based on biochemical stability studies followed by stability studies that examine the one protein formulation in a range of container-closure configurations. A better approach for developing protein formulations for pre-filled syringes is to integrate the examination of critical formulation parameters with the examination of critical syringe parameters. When integrated formulation studies are performed, the combined protein formulation/syringe system can be fully characterized and the selection of the formulation can occur in parallel to the selection of the container and closure.

2:35 Meeting in the Middle: Finding Technical Success in the Development of Protein Formulation and Injection Device Combination Products

Beth Hill, Ph.D., Global Development Director, Drug Delivery and Device Development Technologies, Janssen Pharmaceutical Companies of Johnson & Johnson

Successful co-development of protein formulation and devices into a safe, effective and reliable self-injection product requires CMC teams to cooperate across traditional disciplinary boundaries. Technical performance dependencies are driven by design features of the formulation, primary container and device. Approaches to product design and development to manage this challenge in the current pharma and commercial environment will be discussed.

3:05 Characterization of Extrusion Forces and Product Rheology for Syringe and Device Delivery
Nitin Rathore, Ph.D., Senior Scientist, Drug Product and Device Development, Amgen
Prefilled syringes and auto-injectors are commonly used for parenteral drug administration and require thorough characterization for successful commercialization. This presentation will discuss the impact of various parameters on the delivery forces for syringe injection. Frictional forces, product interaction with syringe barrel and rheological behavior of products have been evaluated. An analytical model is also developed that can be used to fully characterize the design space for a product delivery system.

Sponsored by
 3:35 Daikyo Crystal Zenith® Packaging Systems for Parenteral Administration of Biopharmaceuticals and Biological Products  
Vinod D. Vilivalam, Ph.D., Director of Strategic Market and Technical Development, Daikyo Crystal Zenith, West Pharmaceutical Services, Inc.
The number of drug products packaged in injection devices is increasing, especially in the area of biopharmaceutical drug delivery.  Newer proteins are characterized by higher doses, and are extremely sensitive to packaging materials.  As a result, optimization of drug product stability in an injection device becomes critical in the early stages of the drug development process.  Choosing inert, less reactive packaging materials is essential for maintaining stability over the drug’s shelf life.
The discussion will focus on West and Daikyo products that address various scientific and market needs.  The presentation will include attributes of the Daikyo Crystal Zenith (CZ) 1 mL long prefillable syringe, which is made from a cyclic olefin polymer that is break resistant, silicone oil free, and tungsten free, as it relates to drug storage systems for biopharmaceuticals, and that lends itself to a consistent performing delivery system when combined with an auto-injector. The discussion will also include sterile CZ vials and bulk container systems that are proven to be effective for low temperature storage for biopharmaceutical and cell therapy products.

3:50 Networking Refreshment Break

FORMULATING FOR PRE-FILLED SYRINGES AND COMBINATION PRODUCTS

4:30 Case Study: Development of Protein Therapeutics in Pre-Filled Syringes: Challenges and Strategies

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

Development of biotechnology products such as therapeutic proteins, vaccines in pre-filled syringes (PFS) is attracting considerable interest from pharmaceutical and biotech companies due to increased patient compliance. Although there are several advantages of using prefilled syringes, development of protein therapeutics in PFS offer several challenges from technical to logistics standpoint. A case study will be presented to highlight the key issues to be considered during development of protein products in prefilled syringes.

5:00 Challenges of Formulation and Combination Product Development for a High Concentration MAb Therapeutic

Tom Scherer, Ph.D., Scientist, Late Stage Pharmaceutical and Device Development, Genentech

The use of prefilled syringes for high concentration protein therapeutics presents several additional challenges for product development, as the formulation and the primary container must both maintain the desired product quality attributes throughout manufacture, storage, and use. This presentation highlights formulation specific and device specific attributes, as well as the interactions between them that require consideration for successful development. The examples that will be discussed present a strong case for the interdependence of formulation, process, and device attributes in the development of combination products.

5:30 Reception in the Exhibit Hall

6:30 Close of Day

Day 1 | Day 2 | Download Brochure  

Links to Companion Meetings

Optimizing Biologics Formulation Development 

Lyophilization, Spray Drying & Emerging Drying Technologies 

Protein Aggregation and Emerging Analytical Tools