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Vetter: Clinical syringe packages

Clinical syringe packages may cut time to market and increase clinical trial appeal.

Clinical syringe packages may cut time to market and increase clinical trial appeal.
Clinical syringe packages may cut time to market and increase clinical trial appeal.

Vetter has introduced two clinical syringe packages that make it easier to start syringe development earlier in the drug development process. According to the vendor, starting syringe work earlier, in full or partial parallel with vial development, can cut up to 18 months off time to market.

Vetter’s self-contained, modular packages are designed to provide a clear roadmap through the syringe development process, making it easier to jumpstart syringe work. Vetter’s Clinical Syringe Standard Package includes all development activities through launch. The Clinical Syringe Starter Package offers a range of feasibility testing without the financial commitment to a clinical fill.

Vetter’s Clinical Syringe Standard Package provides all-inclusive service, starting with materials selection—the best combination of syringe, needle, and stopper to meet a compound’s requirements—and continuing through cGMP clinical syringe filling. The Clinical Syringe Starter Package starts with the same materials selection, proceeds through feasibility testing and regulatory consultation, and ends with a non-cGMP stability run. Both packages can be customized to the compound’s requirements and the company’s business goals.

Traditionally, companies begin syringe development after vials near completion of Phase III. Typically, it takes up to two years to complete the transition to syringes, from packaging selection through validation/registration runs. The supplier states that starting syringe development earlier can cut transition time by as much as 18 months, depending upon when syringe work begins and the complexity of the compound.

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