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7:00 am Conference Registration
7:30 Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:15 Chairperson’s Opening Remarks
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 Freeze-Drying In Syringes: Double-Chamber Cartridges Case Study
Speaker to be Announced
The design of devices with double-chamber cartridges (accommodating the lyo in the front chamber and the reconstitution solution in the back) offers challenges and opportunities. There are different solutions proposed by various device companies. Critical issues are related to compatibility of the formulation components with the device components, stability, reconstitution process that allows adequate lyo dissolution or suspension, and complex manufacturing process (filling the lyo solution, freeze-drying one compartment, filling the other compartment with the solution for reconstitution and stoppering).
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
John Patton, Ph.D., CEO, Dance Pharmaceuticals, Co-Founder, Nektar Therapeutics
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
- 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
2:00 Chairperson’s Remarks
2:05 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
2:35 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.
3:05 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.
3:35 Sponsored Presentation (Opportunity Available)
3:50 Networking Refreshment Break
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
5:30 Reception in the Exhibit Hall
6:30 Close of Day