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Products could cut time-to-market in injectables R&D
Vetter Pharma International (Ravensburg, Germany) is introducing two “clinical syringe” packages—Standard and Starter—that could be used during drug development to accelerate the commercialization process. The company notes that the traditional practice is to introduce an injectable in vial form, and then to take upwards of two years to develop a prefilled syringe, starting during Phase III of a product’s development. With the clinical syringe packages, manufacturers can consider going directly to a prefilled syringe. As compared to vials, the prefilled syringe “can differentiate products in a marketplace hungry for patient-friendly systems,” according to a company statement.
The Standard Package provides all-inclusive service, starting with materials selection (syringe, needle, stopper and other components) 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, says Vetter. Even if not planning an immediate launch in a syringe, predetermining syringe feasibility enables a nimble response to a change in market or business priorities; it may also enhance product attractiveness. Both packages are customizable to the needs of the compound and to the business goals of the developer.
Vetter’s Chicago facility is entirely dedicated to clinical manufacturing; the company’s German facilities also offer clinical syringe filling, after which products can move to fullscale commercial filling.