Biotalys has taken a major step towards commercialising its next-generation biofungicide, EVOCA NG, after successfully completing a pilot production campaign that demonstrated the consistency, reproducibility and scalability of its manufacturing process.

 

The AgTech company said the campaign delivered five consecutive successful production batches of EVOCA NG, its first commercial product candidate based on its proprietary AGROBODY technology platform.

 

Conducted in partnership with 21st.BIO, a precision fermentation technology provider, the campaign marks a significant manufacturing breakthrough for Biotalys, generating critical material and process validation data to support regulatory registration activities and future commercial-scale production.

 

The achievement also brings the company closer to its planned market launch, as it prepares to transition from pilot manufacturing to large-scale production through contract manufacturing organisations.

 

“This is a key milestone in the transition of EVOCA NG from development to commercialisation,” said Carlo Boutton, Chief Executive Officer of Biotalys. 

 

“Five consecutive production batches demonstrate the robustness and reproducibility of our manufacturing approach. Through our collaboration with 21st.BIO, we have also achieved a more than 15-fold improvement in production efficiency compared with EVOCA. We are now ready to move into the next phase towards commercialisation: scaling up production with contract manufacturing organisations.”

 

EVOCA NG is designed to help fruit and vegetable growers combat two major fungal threats — Botrytis, commonly known as grey mould, and powdery mildew.

 

Positioned to become Biotalys’ first commercial biofungicide, the product is targeting registration in the United States and European Union in 2029. The two markets together represent an estimated USD 1.1 billion opportunity.

 

The latest manufacturing milestone builds on regulatory progress made by its predecessor, EVOCA, the first-generation product containing the same bioactive ingredient.

 

The regulatory progress of EVOCA is expected to accelerate the pathway for EVOCA NG. Biotalys anticipates a significantly shorter registration process in both the US and EU through equivalency or amendment procedures.

 

With five successful production batches behind it and a substantial improvement in manufacturing efficiency, Biotalys is now shifting its focus to scaling up production — a critical step in turning its next-generation biological crop protection technology into a commercial reality.