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The path to market in a dual-chamber system
As the global demand for injectable systems grows, so does the demand for new, innovative delivery options. What’s driving this global growth? Increased desire for patient convenience, and the explosion in biologics are just a few reasons.
More options for lyophilized drugs needed
Another key market trend is the corresponding growth in lyophilization. Approximately 30% of injectable drugs are lyophilized, a form that’s traditionally delivered via syringe and vial. Today’s manufacturers, however, are looking beyond this platform to find systems that meet the changing needs of today’s market and patient.
One option is a dual-chamber system, a self-contained system that holds both the lyophilized product and diluent. The two are kept separate until administration. Dual-chamber systems offer a number of advantages, including fewer reconstitution steps, reduced needlestick risk, and the potential for use in auto-injector pen formats.
Understanding differences in development
With a dual-chamber system, some alterations to a typical development approach are needed in order to facilitate a compound is suitable for this delivery system as well as determine the optimal cycle for both test runs and scale-up to commercial production.
Typical steps along the development path include:
- Lyophilization feasibility studies - to test the general viability of the product in a dual-chamber system
- Process characterization studies - to assess the current upstream process and advise on studies needed for development in a dual-chamber system
- Design of experiment cycle development and robustness runs - to test the limits of the design space for both primary and secondary drying
- Siliconization/functionality testing - during which different silicone levels are tested for their impact on the product and system
- Engineering runs for commercial scale-up - to ensure the process is scalable