Challenges Associated With In-Use Simulated Administration Of Biologics

The goal of in-use testing of biotherapeutics is to ensure acceptable product quality during dose preparation and administration into patients. This testing comprises of stability and compatibility studies of the materials and diluents used in the preparation, storage, and in-use period of the drug product, tailored to its target route of administration. This ensures patient safety by identifying potential risks due to exposure of not-previously assessed contact materials or diluents.

Considering the wide range of in-use conditions and administration systems and set-ups available, we discuss some of the more challenging aspects surrounding in-use testing for parenteral delivery while reviewing potential strategies to address these issues.

Key Learning Objectives:

• To understand the background and set-up of simulated in-use administration studies
• To understand the key challenges around these studies
• To communicate possible mitigation strategies to these challenges