DEVICE DEVELOPMENT – Selecting Drug Delivery Systems for Higher Doses, Higher Viscosities & Lower Risk
The development of new parenteral biologics with high-volume, high-viscosity formulations (> 1 mL, >15 cP) is triggering the need for devices that can deliver these therapies with the ease, safety, and low injection time required for self-injection.1-3 As these formulations come to market, pharmaceutical and biotech companies must make critical device choices from an array of largely unproven options.2 The following discusses how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.
IDENTIFYING SOURCES OF RISK IN COMBINATION PRODUCT DEVELOPMENT
Particularly risk-prone areas of combination product development involving a primary container and secondary packaging are performance and safety. Fundamental sources of risk include incompatibility with the drug or primary container, or failure to meet usability requirements. One consequence associated with poor selection of a new injection device could be missed regulatory milestones leading to a delayed launch and the associated lost revenue. A second consequence is the potential for high reject rates during development and industrial scale-up, potentially leading to higher costs or delays. Biopharmaceutical companies launching high-volume or high-viscosity formulations must adopt strategies and plan ahead to reduce these risks.
Article information: Nicolas Bralet, Megan Lan. Drug Development & Delivery. https://drug-dev.com/device-development-selecting-drug-delivery-systems-for-higher-doses-higher-viscosities-lower-risk/