Process Systems Enterprise (PSE), the Advanced Process Modelling company, recently launched its new gPROMS FormulatedProducts modelling platform for the integrated digital design of robust formulated products and their manufacturing processes.



Developed in close collaboration with leading pharmaceutical, agrochemical, consumer products and food organisations, gPROMS FormulatedProducts deploys a mechanistic modelling approach to enable scientists and engineers to screen formulations with complex phase structures for quality attributes, determine whether they can be manufactured robustly, and comprehensively explore the design space for the whole formulation and manufacturing chain.

In particular, the platform helps pharmaceutical companies optimise the formulation and manufacture of drug substances and drug products using mechanistic models of material, unit operations and product performance. This enables them to screen new formulations faster against quality attributes including in vivo performance and manufacturability. It also accelerates tech transfer whilst reducing risk and improving R&D efficiency, and facilitates better capture and transfer of corporate knowledge across the organisation.

Sean Bermingham, head of PSE Formulated Products says, “gPROMS FormulatedProducts uniquely meets the needs of the pharmaceutical, agrochemical, consumer products and food organisations when it comes to accelerating innovation, improving product and manufacturing process robustness, and reducing time-to-market.”

Built on PSE’s state-of-the art gPROMS® modelling platform, gPROMS FormulatedProducts includes extensive libraries of mechanistic models for operations such as reaction, crystallization, wet and dry milling, spray drying, wet and dry granulation, blending and tabletting. It also provides databases and calculation methods for physical properties, material properties, equipment and physiology.

Data from batch and continuous experiments can be used to calibrate the manufacture and product models. The gPROMS platform’s unique Global System Analysis capability can then be applied to perform a comprehensive assessment of the impact of input variability and model uncertainty on critical quality attributes (CQAs), allowing the screening and ranking of formulation and manufacturing process alternatives.

Bermingham adds “We have benefited enormously from the feedback we received from PSE’s Formulated Products Advisory Board as well as the input from the Systems-based Pharmaceutics Alliance and our industrial and academic partners in major R&D collaborations such as ADDoPT, C-SOPS, CMAC, D3P and REMEDIES. This has resulted in a tool based on state-of-the-art science that can address practical challenges”.