10105165A model-based scalable and cost-effective process platform to facilitate the manufacture of complex long-acting injectable (LAI) microspheresClosedCollaborative R&DInnovate UKLong-acting injectable (LAI) drug products offer the potential to transform human health through treatment of a range of diseases. Most of LAI research to date has been invested in exploring new APIs and novel drug cargoes for improved therapeutic effect and better patient compliance. This has led to limited research exploring the science underpinning the medicine manufacturing of LAI drug products. A key challenge is that product attributes, e.g., release profile, are sensitive to manufacturing process, affecting performance and quality of end-products. In addition, lack of reference product characterisation further hampers the bench-to-clinic translation of LAI drug products. To untangle these challenges, in-depth characterisations which can establish the link between products' critical quality attributes (CQAs) and manufacturing process parameters are required. There is also a need to develop virtual bioequivalence(BE) testing to enhance LAI formulation's in-vitro/in-vivo correlations. We will develop the world's-first accelerated 'Process-to-PK' LAI platform, integrating microsphere manufacturing processes, product CQAs, predictive release kinetics, and mechanistic pharmacokinetic/BE models. Compared to the conventional homogenisation, our platform can provide more efficient, reproducible and scalable manufacturing process to achieve excellent formulation uniformity. In addition, this evidence-based, data-driven manufacturing platform will significantly reduce the risks in LAI product development and facilitate decision making by linking early-stage manufacturing outcome with later-stage pharmacokinetics with minimum resources requirements. Our work will be the first in the market to link a manufacturing process with in-depth microsphere's CQA characterisation and formulation fate in human-relevant mechanistic PK models. De-risking the complex development of LAIs will lead to more cost-effective therapies, ultimately providing patients and the NHS with treatment options.