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Pharmaceutical and biopharmaceutical leaders can now leverage the power of in-silico approaches to address the unsustainable time and cost that is needed to advance drug manufacturing, production scale up and drug delivery processes.

Computational fluid dynamics helps pharma scale up
For engineers working in the pharmaceutical industry, the real trials begin after a new drug molecule has been discovered. They are then tasked with taking a process that has been designed and verified at a small-scale such as a test tube or a micro-reactor and successfully reproducing this at an industrial scale. Computational Fluid Dynamics (CFD) tools provide engineers with the ability to accurately design mixing vessel equipment at all scales from lab to pilot-plant to production volumes. By doing so, they can deliver huge improvements to process efficacy and product homogeneity. Rather than performing costly experiments at the intermediate “pilot-scale,” engineers are now conveniently able to design equipment using a virtual model which allows them to easily and accurately simulate the flow behaviour and understand the impact of all possible design parameters on the performance and efficiency of their process. They are also able to do this before they embark on expensive decisions such as equipment selection and construction commitment at production scale.

Since it is a virtual model, it is also very simple to scale the model up further to determine if the process is going to work efficiently at the intended production scale. This process can be applied to a wide range of mixing technologies, including traditional stirred tanks but has also been applied to Oscillatory Baffled Flow Reactors (OBRs) and other devices.

Engineers are also able to visualise and quantify the homogeneity of the product over various blending cycles, helping them to better understand the mixing times required for each stage of the process, and to better plan the timing of key additions.

Drug manufacturing

Drug manufacturing needs a lot of time and financial investment. This is where in-silico comes in and it has been known to bring up to 99 per cent time savings in manufacturing. Simulation can help manufacturing via streamlined scale-up processes by optimising upstream and downstream operations that can cut both time and cost.

Drug delivery

In-silico approaches that leverage large-scale variation through virtual patients are critical to enhance the drug-delivery process. At the same time, it needs to account for population variations and also ensure broadly applicable results. Drug delivery can be made safer and more effective through population testing simulation with 90 per cent accuracy from 30 per cent in respiratory drug delivery.

Clean rooms and HVAC

Modelling the multi-faceted airflow patterns ensuing from variable configurations and operations of HVAC systems warrants a sterile clean-room environment with optimised operational costs. Simulation can optimise air-flow patterns and that is critical for clean rooms to comply with safety regulations.

Be it the virtual human laboratory that allows users to understand the effects of implants or drugs in a digital workspace, simulation decreases the risks associated with traditional testing and can also assist in FDA approvals. By increasing safety and performance while reducing the costs and time to market, simulation is a win-win for all!