Brazil's National Biosafety Technical Commission (CTNBio) has issued Biosafety Quality Certificate No. 714/26 to Bioma, a company of the Cogny Ecosystem, authorising the industrial production use of genetically modified microorganisms — the first authorisation of its kind granted in Brazil to a company focused on microbiological agricultural inputs. Until now only pharmaceutical companies and developers of genetically modified plants had received such approval.

The decision complements the infrastructure of Orygen Research, Cogny's research and development centre, which already held level 2 biosafety authorisation for handling microorganisms: Orygen keeps the research, while Bioma gains the regulatory backing to scale the platform to industrial production and then commercialise what it develops.

The technology uses modified microorganisms as platforms for producing specific molecules, without the microorganism becoming an ingredient of the final product. 'We insert the desired gene into a non-target microorganism, which then expresses and multiplies the molecule of interest,' said Artur Soares, Cogny's research and development director. 'At the end of fermentation, the process is terminated and the biomass is processed, leaving only the purified molecule.' Several microorganisms are covered, including a modified strain for producing isoprenoids and phytohormones; all are to be handled under industrial NB-1 containment in closed bioreactors, followed by thermal inactivation or complete sterilisation.

Biosafety follows the rigour of pharmaceutical and industrial fermentation: closed systems, physical segregation of material flows, cleaning and decontamination procedures, access control, microbiological monitoring, a clean-in-place system and a wastewater plant whose thermal unit treats waste at 127°C for 30 to 45 minutes before disposal. Mr Soares sees the platform opening 'production of purified molecules, peptides for agriculture, hormonal molecules, molecules for pest control, molecules for disease control'.

The first commercial outcome is expected in 2027, a hormonal product line produced on the platform, with other molecules in development. Marcelo de Godoy Oliveira, Cogny's chief executive and founder, said the combination of Orygen's research and Bioma's industrial authorisation creates a platform to speed biotechnology discoveries into agricultural products — biological inputs based not only on living organisms but on metabolites and purified molecules made in controlled systems.

Source: AgriBusiness Global