issue2_2025_247BIOPHARMA

45 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 GLATT PHARMACEUTICAL SERVICES solvent and water management, and continuous processing. Indeed, fluid-bed granulation and coating remain among the most energy and water-intensive unit operations. Considering the pressures highlighted during the event, Glatt’s ProCell® platform presents a technically relevant case study for oral solid dosage development. Case study ProCell® operates as a steady-state spouted bed in which spray drying, agglomeration and layering occur simultaneously. A real-time zig-zag-sifter or a sieve-mill-circuit recycles undersized particles, allowing only on-spec material to leave the system. By maintaining thermal equilibrium and avoiding idle periods, the line is reported to reduce drying energy and compressed air demand. The case study presented in the article reports data from an exploratory study with a laboratoryscale ProCell® unit where high-loaded pellets were produced using several polymeric binders. The experiment design is summarised below: Pellets containing up to 99% drug and ~1% polymer binder were produced with mean diameters of 400–440 µm and a narrow size distribution (SD 55–73 µm). Sphericity values of 0.87–0.96 indicated good flow properties, while residual moisture remained below 0.35%, a favourable outcome for moisture-sensitive APIs. Assay recovery reached 97–99% of theoretical content and all formulations demonstrated rapid dissolution at pH 6.8. These results suggest it is possible to manufacture highly spherical pellets with different polymers and API:polymer ratios at high drug loading in a single processing step. High drug loading translates into smaller batch masses and reduced excipient use, which can positively impact overall carbon footprint. In addition, the ability to process various binders at different ratios reflects potential adaptability to evolving regulatory expectations around solvent and excipient selection. One key benefit lies in resource efficiency: continuous discharge coupled to high drug loading can address issues discussed during the conference such as material use, energy consumption and water use. Outlook This technology may offer a practical contribution to the future of formulation, particularly where sustainability and continuous manufacturing intersect. Further investigation will be necessary to quantify its impact, including measurements of energy consumption per kilogram, solvent loss reduction and cycle-time savings. With additional evidence, continuous spouted-bed technology could evolve into a meaningful component of the industry’s broader shift toward more sustainable and agile drug product manufacturing. DAVID YOUNG Editor 24/7 BIOPHARMA

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