June 28-30, 2016
Palm Springs, California
Day One
Wednesday June 29th 2016
08:00 Registration and Breakfast
08:50 Chair’s Opening Remarks
PFS Evolution: Innovation in Design, Controls and Manufacture
09:00 Unpicking Global Regulatory Guidelines for Combination Product
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John Smith
Director, Global Regulatory Affairs , Allergan
Synopsis
- Fully understanding the differences in regulation and classification of combination products depending on geographical jurisdiction
- Developing strategies for efficiently streamlining international product approval
- Ensuring regulatory requirements have been aligned with combination product development
09:30 Linking Device Design Best Practices & Design Controls
Synopsis
- Integrating medical device design best practices to enable more robust product development
- Producing more efficient injectable device manufacturing: design for six sigma, manufacturability, device modeling and DOE studies
10:00 Successful, Cost-Effective & Efficient Industrialization & Scaling Up of Medical Device Manufacturing Pipelines
Synopsis
- Designing, sourcing and qualifying industrial scale production operations in a time and cost effective manner
- Understanding the differences in regulatory demands place upon manufactures for combination products: CDER and CDRH
- Reliably reproducing device testing on an industrial scale to meet regulatory requirements
- How to best account for potential variability in the development and manufacture of combination products: integrating innovative device design and manufacturing procedures
- Evaluating operational requirements to optimize the machine selection process
10:30 Outsourcing for the Development & Manufacturing of PFS
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Shem Fischer
Medical Manager, Contract Manufacturing, Oratech
Synopsis
- Addressing device development, formulation, filling and packaging operations
- Analyzing new unit dose delivery technology
- Developing solutions for the manufacture of niche volume quality devices
10:40 Morning Refreshments & Speed Networking
11:40 Understanding the Design Robustness of a Prefillable Syringe System
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Ross Allen
Associate Senior Consultant Engineer , Eli Lilly and Company
Synopsis
- Understanding the interaction between the drug formulation, the primary container closure system and the device
- Analyzing the functional performance of prefillable syringes and the impact of protein concentration and viscosity, barrel silicone level and distribution, plunger geometry and siliconization, contact pressures
- Identified technical risks for prefillable syringe system designs and understanding the system design robustness to drive improvements in control strategies
12:10 Overcoming Challenges in the Manufacturing of Pre-Filled Syringes
Synopsis
- Successful identification of PFS manufacturing bottlenecks
- Devising innovative solutions to overcoming manufacturing challenges for PFS devices
- Implementing procedures into the operational framework to streamline manufacturing
12:20 Integrated Approach to Filling Technology Selection Needs & Challenges for a Pipeline of Antibody Drug Candidates from Monoclonal Antibodies to Oncolytics Utilizing Containers Ranging from PFS to Custom Containers
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Nan Lin
Manager Drug Product Technology , Regeneron
Synopsis
- How to best validate equipment for filling and packaging processes to suit your specific device needs
- Devising robust strategies for the inspection of filling segments to produce reliable and reproducible validation of aseptic filling
- Advancing multi-filler technology to improve the speed, volume and ability to accurately fill all container types
Detailing Drug Formulation & the Impact on Injectable Devices
13:50 Effect of PFS Siliconization on Particulation & Other Product Quality Attributes of Bioformulations
Synopsis
- Silicone oil leachate content and characterization
- Product quality assessment of multiple protein at different levels of silicone oil
14:20 The Product Quality Research Institute (PQRI) Approach to Leachables and Extractables: Application of Thresholds and Best Practices to Prefilled Syringe Systems
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Diane Paskiet
Faculty Member PQRI Extractables and Leachables, West Pharmaceutical Services
Synopsis
- Analyzing the stability issues of biologics resulting from incompatible materials
- Characterizing the integrated delivery system and individual components within the context of material safety and compatibility to protect patients
- Describing the PQRI strategy for safety thresholds and best practices for identifying extractables and potential leachables
14:50 Afternoon Refreshments & Networking
15:20 Assessing the Risk of Interaction Between Extractables & Leachables (E&L) & Therapeutic Proteins
Synopsis
- Detailing the need for this risk assessment
- Addressing the tools and processes for performance of risk assessment
- Analyzing the caveats and limitations to E&L risk assessments
- Looking to the future of E&L risk assessment testing
15:40 A Visualization Approach to Characterizing Complex Mixtures of Extractables/Leachables (E&L) & Other Pharmaceutically Relevant Compounds using High Resolution LC-MS with 2-D and 3-D Mass Mapping
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Doug Kiehl
Team Leader - Spectroscopy, Raw Materials and Extractables & Leachables, Eli Lilly and Company
Synopsis
- Detecting, identifying and profiling of E&L associated with packaging and container systems, delivery devices and process equipment
- Establishing of a comprehensive profile of extractable chemical entities. And overcoming analytical challenges.
- Discussing the application of 2-D/3-D mass mapping, mass difference correlation and visualization of high resolution exact mass LC-MS datasets to simplify interpretation of complex mixtures.
16:10 Panel Discussion: Analyzing Extractables & Leachables & Device Design
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Doug Kiehl
Team Leader - Spectroscopy, Raw Materials and Extractables & Leachables, Eli Lilly and Company
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Diane Paskiet
Faculty Member PQRI Extractables and Leachables, West Pharmaceutical Services
Synopsis
- Biocompatibility testing for plastics and deliver devices, and linking in a meaningful way with extractables & leachables testing
- What does appropriate E&L testing look like for single-use system (SUS) components for manufacturing process?
- E&L chemical entities and potential protein interactions: How important is it to evaluate this, and how might this be achieved in a consistent and meaningful manner across industry?
17:00 Chair’s Closing Remarks
