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bioRxiv · 10.1101/2025.10.14.682267

Clinical-grade Plant-made nanomaterials: from Process Design to the construction of a Manufacturing facility.

Pivotto, D.·Rosa, A.·Elsheikh, A. M.·Gecchele, E.·Zampieri, R.·Raneri, A.·Garonzi, V.·AVESANI, L.
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Abstract

Plant-made nanomaterials are proteinaceous elements that are emerging as multi-purpose and versatile tools in the therapeutic landscape. In the context of autoimmune diseases, Tomato Bushy Stunt Virus (TBSV) has been previously explored as a platform for inducing immune tolerance by displaying disease-specific immunodominant peptides--offering a potential path toward disease remission. In this study, we developed a dedicated facility and a GMP-compliant manufacturing process for producing TBSV-based nanoparticles engineered to display peptides relevant to specific autoimmune disorders. Data collected from multiple non-consecutive pilot-scale production batches were used to build a simplified techno-economic model of the process. The process is readily scalable and offers opportunities for further improvements, supporting the potential to meet market demands for early-stage therapeutic interventions in autoimmune diseases. Additionally, an environmental, health, and safety (EHS) assessment of the process demonstrated a highly favorable environmental output index and minimal associated risks, reinforcing the platforms sustainability. These results support the viability of plant-based manufacturing for therapeutic nanomaterials and highlight TBSVs potential as a novel platform for tolerance-inducing treatments in autoimmune diseases.

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Pivotto, D., Rosa, A., Elsheikh, A. M., Gecchele, E., Zampieri, R., Raneri, A., Garonzi, V., AVESANI, L.. 2025-10-15. Clinical-grade Plant-made nanomaterials: from Process Design to the construction of a Manufacturing facility.. https://doi.org/10.1101/2025.10.14.682267

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