Clinical Phase-Appropriate Combination Product Development And Seamless Transition To Commercialization: Strategic Considerations And Key Differences

By Anna Jackson, M.S., PMP, Manager, Product Development and Commercialization (PD&C), Kymanox Corporation

Developing combination products—comprising drug, biologic, and/or device components—requires strategic planning that evolves across clinical phases to ensure a seamless transition to commercialization. A key challenge lies in selecting appropriate container closure systems and delivery devices for each clinical phase while considering the final commercial presentation. Early-phase studies often utilize vials for flexibility and cost-effectiveness, while later phases transition to more complex systems like prefilled syringes or autoinjectors, which require increased regulatory oversight and design documentation.

Sponsors must understand the differences between clinical and commercial requirements in design verification, packaging, labeling, shelf-life testing, human factors, and manufacturing. Clinical development typically focuses on essential functionality and safety under controlled conditions, using manual or semi-automated processes. In contrast, commercial development demands comprehensive testing, branding, user interface validation, and automated manufacturing.

Human factors play a vital role, with early studies identifying potential use-related risks and later stages requiring validation of real-world usability. Similarly, shelf-life and shipping studies are limited during clinical phases but must be fully validated for commercial products.

Aligning clinical and commercial strategies—such as using consistent container closure systems—can minimize rework and accelerate regulatory filings. Sponsors should also anticipate future manufacturing scale-up to meet market demand efficiently.

By thoroughly understanding and planning for the technical, regulatory, and logistical differences across development phases, sponsors can optimize timelines, reduce costs, and increase the likelihood of a successful product launch. Early integration of these considerations sets the foundation for a streamlined, phase-appropriate combination product development program.