Serán BioScience has launched a predictive compaction simulation service that transforms dry granulation process development by enabling rapid, efficient, and material-sparing scale-up from laboratory to kilo-scale manufacturing. This advanced service leverages state-of-the-art equipment such as the Medelpharm Style compaction simulator and the 1-ST Press, which together create a platform for in-depth ‘in-die’ analysis using as little as 100mg of material. These sophisticated tools allow Serán’s scientists to characterize critical material properties and simulate roller compaction, predicting vital processing parameters—including roll force and ribbon solid fractions—for both ductile and brittle substances, thus fostering a more data-driven and scalable approach to oral solid dosage development.
Features and Benefits
The key features and benefits of this new service include exceptional efficiency process and formulation development, greatly reduced material consumption, and compressed development timelines. The predictive simulation capabilities mean that essential production criteria can be established at the bench with minimal material, before any scale-up. This dramatically lowers development costs, enables rapid prototyping of scalable intermediate and final drug products, and ensures consistent, robust tech transfer from bench through kilo-scale production. The approach benefits from Serán’s complementary expertise in solid dosage form development, such as tablets, capsules, and multiparticulates, providing not only statistical power in small batches but also reliable scale-up based on rational, data-rich process design.
Applications
Applications for this service span the pharmaceutical development spectrum, including early-stage formulation screening, process optimization, robust tech transfer, and manufacturing process validation for solid oral dosage forms. Its unique, material-sparing nature is especially valuable in preclinical and early-phase development when active pharmaceutical ingredient (API) supplies may be extremely limited. It’s also instrumental in tackling challenging formulation issues, such as achieving target release profiles or manufacturability for poorly compressible actives, and supports both clinical and commercial program objectives. By integrating advanced compaction simulation, Serán delivers a smooth transition from research to market, supporting innovative solutions for new and complex therapeutic candidates.