International Technology Transfers: A Playbook for Success: Poster Presented at PDA Week 2025.

The BIOSECURE Act, along with the recent election, stands to influence the reshoring of biomanufacturing activities in the United States, significantly impacting the growth of international technology transfers. However, these technology transfers are complex, requiring careful coordination across regulatory, quality, operations, and technical disciplines. When executed between international sites, these transfers become even more intricate due to varying regulatory requirements, compliance landscapes, and operational constraints. The resultant stress placed on people, processes, and technology results in an increased likelihood of misalignment, knowledge gaps, and inefficiencies that can negatively impact project timelines, budget, and ultimate product quality. In this poster, we will discuss a refined International Technology Transfer Playbook that we have developed to successfully approach technology transfer planning and execution. Included are strategies for comprehensive scope planning, successful knowledge and process transfer, risk management, validation, operational infrastructure, and training/proficiency requirements, which lay the groundwork for successful project delivery. Through practical examples, we will illustrate how this framework leads to successful outcomes for both companies and patients. Through deliberate planning and coordination, companies can accelerate commercialization timelines while maintaining product quality and compliance, extending their reach in global markets.