- Benuvia Operations has signed a Letter of Intent with Khona Scientific to evaluate biosynthetic routes for controlled-substance APIs.
- The collaboration will assess scalable, compliant and sustainable API production approaches using biosynthetic starting materials.
Benuvia Operations, LLC has signed a Letter of Intent (LOI) with Khona Scientific Inc. to collaborate on the evaluation and development of biosynthetic pathways for the commercial production of selected controlled-substance active pharmaceutical ingredients (APIs). The companies said the collaboration is focused on regulated pharmaceutical development and manufacturing.
Under the LOI, the parties plan to combine Benuvia’s expertise in regulated pharmaceutical development, GMP manufacturing and controlled-substance compliance with Khona’s biosynthesis technology and precision fermentation capabilities. The work will focus on evaluating biosynthetically derived key starting materials for API production.
The collaboration aims to assess scalable and compliant approaches to API manufacturing while maintaining quality, regulatory compliance and controlled-substance oversight. The companies said the initiative is intended to support a more resilient and diversified pharmaceutical supply chain for domestic and international customers.
“This Letter of Intent reflects Benuvia’s continued focus on expanding compliant and scalable pathways for the development of highly regulated APIs.”
Terry Novak, Chief Executive Officer of Benuvia Operations
The LOI establishes a framework for technical collaboration, information exchange and development evaluation activities. Any future agreements would be subject to regulatory considerations and alignment on technical, commercial and compliance objectives. The framework was developed with support from Madrone Process Development, which assisted with aligning technical objectives, regulatory considerations and development pathways.
