- Attempting to predict injectability of novel formulations (particle suspensions and high viscosity drugs)
- Quickly assessing risks (backpressure, leakage, pain) with virtual “in-silico” methods
- Optimising device and formulation parameters with minimal physical testing
Developing novel formulations incurs significant risk, and recent trends in high viscosity, large volume injection pose much uncertainty around appropriate delivery methods. It is highly beneficial to predict the behaviour of formulations and devices at the earliest possible stage to avoid expensive failures later in the development process. Computer simulations are now more powerful than ever and can offer great advantages in the medical sector but have not yet seen the same level of uptake as other safety-critical industries such as aerospace and automotive, in part due to the highly complex nature of biological systems. Crux have partnered with Gilead Sciences to develop models to investigate needle occlusion, human tissue backpressure, leakage risk and pain. These models show good agreement with physical experiments, and reveal important relationships relating device & formulation parameters to injectability metrics.
Joel Gresham, Simulation Expert & Life Sciences Lead, Crux Product Design Ltd.
John Majewski, Device Development Engineer , Gilead Sciences