Systems-based Pharmaceutics (SbP) is a holistic approach aimed at increasing R&D efficiency and maximising robustness in drug delivery and manufacture.

The SbP vision considers drug substance manufacture, drug product manufacture and product performance as a single system. This reduces iterations between formulation and manufacturing process design, reducing costs and time-to-market.

The Systems-based Pharmaceutics Alliance

PSE and six major pharma companies are collaborating in the Systems-based Pharmaceutics Alliance (SbPA) to accelerate realisation of this vision, increase adoption of the resulting tools and ensure their regulatory acceptance. Members work closely together in a pre-competitive relationship to develop integrated digital design techniques based on mechanistic models, verified by targeted experiments.

Systems-based Pharmaceutics concepts

The aim of SbP is end-to-end decision support for development of drug manufacture and delivery systems. It was envisaged as a means to improve and accelerate the quality of drug products and their manufacturing processes as well as to reduce the number of iterations required between product formulation and manufacturing process design.

Progress

SbP Alliance Phase 1 (2013-2015) and Phase 2 (2016-2018) have been completed, Phase 3 (2018-2021) is currently in progress.

Technology

A key aim of the SbP Alliance is to embody SbP concepts in the form of software for engineers and scientists. One such development is PSE's gPROMS FormulatedProducts modelling platform for the integrated digital design of robust formulated products and their manufacturing processes.