ORIGINAL RESEARCH article
Front. Plant Sci.
Sec. Plant Biotechnology
This article is part of the Research TopicPlant Molecular Farming for Biopharmaceutical Production and BeyondView all 15 articles
Clinical-grade Plant-made nanomaterials: from Process Design to the construction of a Manufacturing facility
Provisionally accepted
Denise Pivotto1
Aya Maged Elsheikh2
Anthony Rosa2
Roberta Zampieri2Elisa Gecchele2Alessia Raneri1Valentina Garonzi2
Linda Avesani1*- 1University of Verona, Verona, Italy
- 2Diamante SB, verona, Italy
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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—oXering a potential path toward disease remission. In this study, we developed a dedicated facility and a Good Manufacturing-compliant 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 oXers opportunities for further improvements, supporting the potential to meet market demands for early-stage therapeutic interventions in autoimmune diseases. Additionally, a preliminary Environmental, Health, and Safety (EHS) assessment of the process showed a highly favorable environmental output index and minimal associated risks, reinforcing the platform's sustainability. These results support the viability of plant-based manufacturing for therapeutic nanomaterials and highlight TBSV's potential as a novel platform for tolerance-inducing treatments in autoimmune diseases.
Keywords: nanobiotechnology, peptide Liprin (pLip), plant molecular farming, Rheumatoid arthritis, TBSV, Tolerance induction, viral nanoparticles
Received: 14 Oct 2025; Accepted: 05 Dec 2025.
Copyright: © 2025 Pivotto, Elsheikh, Rosa, Zampieri, Gecchele, Raneri, Garonzi and Avesani. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Linda Avesani
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.