Clinical Phase Manufacturing Support
What you need. When you need it.
Woodstock Sterile Solutions offers a comprehensive clinical phase supply capability. Whether in earlier phases or late phase the final dose format is critical and at WSS we drive to that selection early in development.
We are unique in the blow-fill-seal CDMO space in our ability to efficiently provide small-run prototypes using limited supplies of API material and then having the capabilities to scale that seamless to commercial production. Today, Woodstock runs one of the smallest BFS packaging systems in the entire industry, which means smaller amounts of API required and nimbler development.
At the same time, our clinical capabilities are completely scalable, allowing us to deliver product to meet various volume requirements – from piloting, R&D and early-phase clinicals through late-phase and regulatory submissions.
Because of our approach to development in the early and clinical phases of your drug development, your first delivery system can be your final delivery system – enhancing scalability and speed to market while reducing the risk and cost of development.
Fully Functional R&D Capabilities
- Two pilot-scale machines
- Pouching and packaging capability
Clinical Manufacturing and Support
- Phase I/II/III support
- Placebo development and manufacture
- Process scale-up
- Submission and stability batches