This technology enables representative, sustainable and cost-effective transport simulation studies to demonstrate robustness of the drug product and the absence of product quality impacts (PQI) after shipping and distribution.
During process validation, the shipping lane and distribution process is qualified and the robustness of the drug product against transportation stresses has to be demonstrated. Real life shipping studies are a common way to achieve that. The focus of our research is to understand the stress conditions, the resulting liquid agitation and correlate this with quality impacts of biologics with a novel transport simulator.
In this bottom-up approach, understanding of fluid behavior and interfacial stress in drug product containers was gained with CFD simulation and validated with high-speed image analysis. Recently, real world data of representative pallet shipments was collected to understand transportation vibration stress throughout the stack of packaging to serve as a stress input for model systems.
A custom transport simulation device was developed which allows for representative lab-scale testing at cold chain temperatures with agitation in combined vertical and horizontal axes. The hypothesis that interfacial and shear stress during transport can lead to protein instability was tested. Indeed, visible particles and protein instabilities were detected with multidimensional vibrations, where state of the art transport simulation only in vertical direction did not. Additionally it was also demonstrated that formulation scientists have access to mitigations and excipients to develop robust products.
Learning Objectives:
Describe transport agitation stress and the resulting fluid dynamics of drug products.
State way to carry out a representative simulated drug product shipping test.
Explain the challenges with vibration stress analysis during real life shippments.
How to describe real life vibration acceleration data and translate it into power spectral density.
Select suitable model systems for testing protein formulations during development.