In-Use Stability Studies
In-use stability studies designed and conducted by Coriolis Pharma’s expert team ensure your active pharmaceutical ingredient can withstand the handling procedures related to patient administration. Specifically, they verify stability, efficacy and safety throughout exposure to surfaces like tubings, infusion bags, pumps, closed-system drug transfer devices and filters en route to the patient.
Evaluating Factors Impacting In-Use Stability
In-use stability studies assess various factors, including the effect of dilution and the dilution medium, storage and handling in clinics, potential adsorption to surface materials, shear forces during application, variations in extractable volume and reconstitution, formation or introduction of aggregates and (sub)visible particles and more.
Closed System Drug Transfer Devices (CSTD)
The USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings provides standards for the safe handling of hazardous drugs and recommends closed systems for administration to minimize the risk of exposure to healthcare personnel, patients and the environment. Closed system drug transfer devices (CSTDs), according to the National Institute for Occupational Safety and Health (NIOSH), refer to injectables that must be drawn from the vial into a syringe and either administered to the patient or transferred to an infusion bag. They mechanically prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. We follow comprehensive protocols when testing closed system transfer devices for their ability to protect healthcare workers as well as the drug product.
In-Use Stability Studies for Your Drug Product
We design in-use stability studies for many biopharmaceutical drug products, including highly concentrated protein formulations, low-concentration protein drugs and active pharmaceutical ingredients like live virus vaccines and viral vectors that fall under biosafety level 2.
Your Phase
Coriolis offers phase-appropriate, in-use stability studies, including highly flexible early-phase studies conducted under good research practice (GRP) guidelines, later-phase studies utilizing controlled environments and qualified equipment and GMP environments with full quality assurance support.
In-Use Stability Study Resources
Articles
Partnering with Scientific Excellence to Derisk and Accelerate Drug Development
July 15, 2024
Publications
April 1, 2024
