Technology Transfers: Best Practices For Optimizing Success And Mitigating Risk

By Derek Gallo, Director of Drug Product Development, Global Technology Transfer and Strategic Projects

Taking a pharmaceutical product from development to commercial launch requires a highly orchestrated technology transfer process involving multiple stakeholders, a deep understanding of the specific determinants of complexity that make each project unique, and a robust framework for the continuous assessment of business, regulatory, product quality, and technical risks.

In many ways, the successful transition of drug products between developers and manufacturers is equal parts science and art, defined by enabling processes, a culture of collaboration to support them, and, perhaps most important, a foundation of trust. Specifically, drug sponsors are sharing the product, process, and analytical information needed to bring their drug to market. To do this with confidence, they must be able to trust that their manufacturing partners will bring the following to the table:

• The physical capabilities, management systems, and control strategies required to ensure quality and manage risks
• Extensive process and product understanding of a broad portfolio of drug types and manufacturing options
• Closed-loop quality management
• Full data transparency and accessibility
• Sufficient human capital and facility space, with the capacity to take on new projects
• Extensive experience to support a variety of process and technical requirements, and confidence in the ability to deliver “right first time” and on time

In return, manufacturers must trust that sponsors will support open, bidirectional communication to ensure that all stakeholders have access to essential information when they need it. This two-way flow of process and product information ensures the alignment of upstream development with downstream scale-up.

When built on this foundation of trust, the transfer of production between sites can improve productivity and efficiency, reduce program costs, optimize regulatory readiness, and accelerate time to market.

This white paper provides direction for ensuring successful technology transfer by identifying common challenges and offering case-based solutions and best practices for overcoming them.