The approach allows pharma organisations to explore the formulation and manufacturing decision space for drugs and other formulated products rapidly and effectively using a knowledge-driven approach. The information from this analysis is then used to design the best ‘next experiment’, on order to minimise experimentation time and cost. In turn the models are used in conjunction with global system analysis techniques to quantify uncertainty in key model parameters, and the resulting effects on key performance indicators (KPIs). Mechanistic models of drug products, substances and their manufacturing processes are progressively refined using targeted experimental data. The approach is shown schematically below:Įssentially, it combines detailed mechanistic models at multiple length scales – capable of providing accurate prediction across the decision space – with comprehensive material and equipment characterisation services.
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