Case Study: Integrated Drug Substance to Drug Product Manufacture

A small biotech client had identified a promising new drug candidate and required rapid, parallel development of both drug substance and drug product to meet ambitious clinical milestones. The initial synthetic route involved challenging reaction conditions highlighting the need for route optimisation to improve scalability, efficiency and overall process robustness. In parallel, tailored formulation development was essential for Phase I clinical readiness.

At Arcinova, we drive smarter drug development through collaboration and innovation—integrating drug substance, formulation, and drug product manufacture to reduce material use, minimise transfers, and enhance quality control.

Download a copy of our Integrated Drug Substance to Drug Product Manufacture case study today.