Tech Transfer In Late-Stage Oral Solid Dose Projects: Lessons Learnt And Best Practices From A CDMO Perspective

Tech transfer in oral solid dose (OSD) manufacturing is a critical and often underestimated phase, especially for late-stage biotech companies nearing their first commercial launch. Unlike earlier transfers where flexibility is common, late-stage transfers, typically after Phase 2 trials, demand consistency, meticulous documentation, and process validation under GMP conditions.

A frequent challenge for biotechs is documentation quality, which can be fragmented or inconsistent due to development across multiple sites or partners. To mitigate this, conduct an early documentation audit to ensure all materials—including batch records, raw material grades, and analytical methods—are standardized and complete. Another key issue is equipment mismatch between development and commercial sites, which can impact critical quality attributes like content uniformity.

Beyond documentation, capturing tacit knowledge through joint workshops and site visits is crucial, as this informal understanding (e.g., why certain parameters were chosen) goes beyond what's in the documents. Finally, successful transfer relies on proactive risk management and early planning for validation to ensure the process is robust, reproducible, and compliant, avoiding costly delays to commercialization.