Article | April 19, 2022

Off-The-Shelf Vs. Novel Devices: Considerations When Selecting A Drug Delivery System

By Scott Arra, Sr. Director, Business Development, and Evan Edwards, Chief Development Officer, Kymanox Corporation, Morrisville, North Carolina


Pharmaceutical and biotechnology companies continue to develop drug and biologic products that require alternative routes of administration, such as nasal delivery devices, auto-injectors, pen-injectors, and on-body / wearable delivery systems. Companies must consider a multitude of factors when determining the right delivery system for their drug. Furthermore, when life science companies introduce a change in the drug or in the device for on-the-market products, there are additional factors to evaluate.

Currently, companies have two options for drug delivery technologies: 1) selecting ‘off-the-shelf’ drug delivery systems, and 2) developing novel or unique devices. Whether a company is bringing a novel therapy to market or altering current devices for lifecycle management, companies must review their options and determine the best selection for administration without effecting drug efficacy, quality, and safety.

This article explores challenges with platform selection and the advantages and disadvantages of off-the-shelf and novel devices.

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