The Value of a Bd Integrated System for Combination Products
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چکیده
The number of biological therapies in development to treat chronic diseases has risen steadily over the years. The fact that many of these therapies are designed for home delivery by patients or caregivers via subcutaneous injection, combined with the increasing complexity of longer acting formulations, larger injection volumes and longer injection durations, has raised the bar for seamless injection delivery technology. Patients today receive these drugs inside prefilled injection devices, together called combination products. These combination products include auto-injectors, wearable injectors, and prefilled syringes. To bring a drug-device combination product to market, pharmaceutical companies must select and assemble multiple components that work together optimally to deliver the drug formulation safely and effectively. These components include, but are not limited to: • A primary container consisting of a syringe barrel, stopper, plunger rod and backstop • A secondary delivery system such as an auto-injector or wearable injector • An add-on needlestick safety guard.
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