Integrating experimentation and modelling

An integrated, holistic approach to accelerate drug development

The Centre of Excellence for Pharmaceutical Formulation & Manufacture applies an integrated and holistic approach to drug formulation and manufacture.

This combines model-based analytical technology and experimental services to help accelerate the development of drugs and design of their manufacturing processes.

How it works

The approach is shown schematically below:

Essentially, 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.

Mechanistic models of drug products, substances and their manufacturing processes are progressively refined using targeted experimental data. 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). The information from this analysis is then used to design the best ‘next experiment’, on order to minimise experimentation time and cost.

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 integration of formulation, process design and experimentation made possible by this approach leads to significant acceleration of development programmes, improvements in R&D efficiency and more effective and efficient manufacturing processes.

What we offer

The CoE offers the following specific services as part of our overall set of solutions for pharma companies :

• Development and application of fit-for-purpose models that combine detailed mechanistic models at multiple length scales to provide accurate prediction across the decision space.
• Targeted experimentation to reduce time and cost.
• The most advanced mechanistic modelling tools available from PSE and RCPE, for detailed representation of processes such as crystallization, solids processing and oral adsorption, as well as tools that combine CFD and discrete element modelling.
• Model-based workflows that help companies integrate data and models to design robust products and processes rapidly and effectively.
• A process that allows design of process and products in a way that maximizes R&D efficiency and minimises (manages) risk.
• Technology transfer via models that can be used to support engineering and operations after transfer
• For technology providers, proving that their technology works robustly and effectively.

We transfer these solutions to the company in the form of usable software tools that can be deployed not only in further research but also in engineering and operation.