Viral Vector Technology Transfers: A Guide To Success

By Jason Rodriguez and Michael Shen, MilliporeSigma

Effective viral vector technology transfer is essential to advancing gene therapy programs from development to GMP manufacturing. However, this transition is often hindered by technical complexity, inconsistent documentation, and misaligned expectations between development and manufacturing teams. Achieving a smooth transfer requires structured collaboration, standardized processes, and early integration of manufacturing considerations into development.

Seven core elements underpin successful transfers: clear communication and alignment, robust risk management, comprehensive documentation, analytical harmonization, pilot and engineering runs, adoption of automation and digital tools, and proactive regulatory planning. Consistent communication helps prevent delays and scope drift, while harmonized analytical methods and documentation ensure reproducibility and data integrity. Pilot-scale testing and digital monitoring enable early identification of scale-up risks, supporting smoother process validation.

Embedding automation and data-driven oversight throughout the transfer process enhances traceability and reduces human error. Likewise, a Quality by Design framework ensures that critical parameters are defined, controlled, and ready for regulatory review from the outset. Collectively, these strategies transform technology transfer from a major bottleneck into a catalyst for accelerated, reliable viral vector production—enabling manufacturers to deliver high-quality, scalable therapies more efficiently and bring advanced treatments to patients faster.