What question did this study set out to answer?

The aim is to develop a manufacturing process for TBSV-based nanoparticles targeting autoimmune diseases.

January 10, 2026Frontiers in Plant Science0 citationsOpen Access

Clinical-grade plant-made nanomaterials: from process design to the construction of a manufacturing facility

DPDenise PivottoUniversity of Verona ARAnthony RosaUniversity of Verona AEAya Maged ElsheikhUniversity of Verona

Key Result

TBSV-based nanoparticles engineered to display autoimmune disorder peptides were successfully produced in a scalable and sustainable process, supporting therapeutic interventions.

Key Points

The aim is to develop a manufacturing process for TBSV-based nanoparticles targeting autoimmune diseases.
Developed a manufacturing facility compliant with Good Manufacturing standards
Engineered TBSV nanoparticles to display immunodominant peptides
Conducted multiple pilot-scale production batches
Built a techno-economic model for process analysis
Assessed environmental health and safety outcomes
The manufacturing process is scalable and meets market demand
Sustainability assessments show favorable environmental output
Demonstrated potential for TBSV as a tolerance-inducing treatment platform

Structured PICO

Population

Nicotiana benthamiana plants cultivated indoors under controlled environmental conditions as a bioreactor for producing TBSV.pLip nanoparticles

Intervention

Tomato Bushy Stunt Virus (TBSV)-based nanoparticles engineered to display the peptide Liprin (pLip)

Outcome

Production yield and operational expenditure (OPEX) for manufacturing TBSV.pLip nanoparticles

A GMP-compliant plant-based manufacturing process for therapeutic viral nanoparticles is technically feasible and scalable, with labor and facility costs being the primary economic drivers.

Main Result

Absolute Event Rate: 0% vs 0%

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 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 offers 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.

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