The Value Of A BD Integrated System For Combination Products

By Dr Theresa Bankston, Director, Technical Services

The growing complexity and regulatory rigour of combination products has called for increasingly innovative delivery devices. In this article, Theresa Bankston, PhD, Director, Technical Services looks at the advantages of using an integrated system for these drug-device combination products rather than sourcing components from different suppliers. As well as avoiding problems such as breakage and incompatibility, integrated products can offer solutions at every interface between the drug, container and delivery device and save significant amounts of time and money.

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.

Drug makers and their contract manufacturing partners have the option of sourcing these components from a variety of suppliers. However, pharmaceutical companies who purchase components separately take on additional risks that can be significantly reduced by selecting an integrated system instead.