Five Steps To Derisking Your Tech Transfer And Validating Your Process

The tech transfer is the first moment of true partnership between drug sponsor and CDMO and a major step on the journey to successful clinical and commercial biologic manufacture. Though the pressure to move quickly is ever present, rushing through the tech transfer stage can lead to late-stage delays and process failures. But, if a CDMO and sponsor emphasize the importance of thorough transfer of data, protocols, and processes while identifying opportunities for improvement, innovation, and risk mitigation, a drug program will be strategically positioned toward success.

To support this effort, there is a proven five-step approach to tech transfer which streamlines the path from onboarding to clinical and commercial production via robust process understanding, scale-down models, and process characterization, validation, and verification. Download the full article to explore the ins and outs of this strategy and the real-world impact it can have on your process.