Strategies and Approaches for Integrating Multi-Sourced Syringe Components into Combination Product CM&C Development

• Drivers for Second Sourcing
• Considerations in Source Selection
• Strategies for Performance Evaluation
• Case Study

The efficiency of delivery and improved patient experiences have long made pre-fillable syringes preferred options for incorporation into drug/device combination products.  Pharmaceutical companies often source these constituent components, e.g. syringe barrels and elastomeric plungers, from multiple suppliers to maintain business continuity, lower manufacturing cost(s), and to ensure reliable and consistent supply of these products to patients. However, inclusion of multi-sourced components in a clinical asset, or a marketed product, can significantly increase CM&C development complexity, adding cost and timeline risk. This presentation discusses a streamlined strategy for selecting, developing, and integrating multi-sourced syringe components into CM&C development.  Bracketing and matrixing principles are leveraged to reduce development study design while still producing robust suitability, equivalency, and stability data packages required to support regulatory submissions.  Approaches to assessing and mitigating specific timeline, regulatory, and technical risks are also discussed in detail.

Pete Sargent, Advisor—Engineering , Eli Lilly and Company