Advances in Serrumab Antibody Biotechnology (TLR3-TLR6): From Subcloning to Proof-of-Concept Validation

• Grant number: 25/00704-5
• Support Opportunities: Scholarships in Brazil - Master
• Start date: August 01, 2025
• End date: February 28, 2027
• Field of knowledge: Engineering - Biomedical Engineering - Bioengineering
• Principal Investigator: Manuela Berto Pucca
• Grantee: Geovanna Maria Malachias Pires
• Host Institution: Faculdade de Ciências Farmacêuticas (FCFAR). Universidade Estadual Paulista (UNESP). Campus de Araraquara. Araraquara , SP, Brazil

Abstract

The project proposes an innovative approach for the development and optimization of the production of the human monoclonal antibody Serrumab, designed to neutralize toxins from the venom of the Tityus serrulatus scorpion. This venom is responsible for a significant number of severe envenomation cases in Brazil, posing a critical challenge to public health.Serrumab, whose patent was granted in 2021 (BR102013005043-1) and lists the project supervisor, Dr. Manuela Berto Pucca, as one of the inventors, offers significant advantages over traditional heterologous antivenoms. It stands out for its higher specificity, efficacy, and reduced risk of adverse reactions. However, technical challenges related to the low production efficiency in bacterial expression systems have hindered progress in preclinical development.To overcome these barriers, the project is based on the use of the yeast Pichia pastoris as an expression system, a high-productivity biotechnological platform free of contaminants such as lipopolysaccharides (LPS) and capable of performing essential post-translational modifications critical to antibody functionality. The workflow includes the construction of recombinant vectors, expression, purification, and functional validation of Serrumab, with both in vitro and in vivo analyses to confirm its therapeutic efficacy.With this innovative approach, the study aims to raise Serrumab's technological readiness level (TRL) to TRL6, paving the way for future clinical applications. This project reinforces the commitment to scientific and technological advancement, presenting a promising solution to a highly relevant public health issue in Brazil. (AU)