Olon in biocontrols agreement
Italian CDMO Olon has reached a long-term strategic partnership for the manufacturing of the protein-based biocontrol products of Belgium’s Biotalys. This, the companies said, will secure the global supply of Biotalys’ first product, Evoca, a biofungicide that is planned for market introduction in the US in 2H 2022, subject to regulatory approval.
Evoca controls diseases such as Botrytis and powdery mildew in fruit and vegetables. As well as reducing dependency on chemical pesticides that might lead to residues in harvested produce, Biotalys said that it offers “a distinctive new tool to manage pathogen resistance development”.
Olon will produce the active ingredient at its biotech manufacturing sites in Capua and Settimo Torinese, which both have many years of experience in microbial fermentation. They have respective capacities of 35 m³ in bioreactors and batches of up to 112 m³, far above what has so far been reached with Biotalys’ products. The company is a major player in the sustainable production of proteins.
“This upscaling therefore signifies a major step forward in terms of production efficiency and scalability of protein-based biocontrols,” Olon stated. “Olon will both handle the fermentation process of the products developed by Biotalys in its laboratories in Ghent and purify them into the technical intermediate which will then be formulated by an external provider to create the end products.”
Biotalys submitted Evoca for registration to the US EPA in December 2020. It passed both the provided completeness check and the preliminary technical screening. Separately, it was submitted for approval in California, which performs its own in-depth review, in April 2021. In the EU, EFSA and the College for Approval of Crop Protection Products & Biocides have confirmed that that the registration dossier submitted for the active substance in March 2021 is admissible for review.