The Single-Site Solution To Eliminating OSD Tech Transfer Risks

By Alok Kapadia, MIKART

Technical transfer for oral solid dose products is a high-risk endeavor because standard documentation often fails to capture the tacit knowledge and analytical nuances essential for successful replication. Moving processes between facilities introduces variables like equipment configurations and supplier differences that can trigger quality issues or regulatory delays.

A single-site, U.S.-based CDMO model mitigates these risks by preserving institutional knowledge and enabling real-time collaboration between formulation and manufacturing teams. This integrated approach, managed by a single project leader, ensures scalability is designed into the product early, avoiding costly late-stage reformulations. Ultimately, selecting a partner with commercial-scale capability by Phase 2 minimizes logistical complexity and ensures supply chain continuity, protecting the program throughout the clinic-to-commercial journey.