Beyond Data Packages: Derisking Tech Transfer To CDMOs

Technology transfer to a CDMO is not the “cut and paste” exercise sponsors hope it will be. Whether the project involves small molecule manufacturing, biologics processing, cell and gene therapies, or QC methods and development, the same pressure points often emerge: an incomplete “data package,” equipment and site differences, method variability, international standards, and the mutual decisions needed to support CMC frameworks such as ICH Q5E.

In this Outsourced Pharma Live session, experienced panelists discuss how sponsors can adequately prepare for a transfer and align with CDMOs, anticipate workload, and use tools such as design of experiments, smarter documentation systems, and in silico modeling to improve the odds of a right-first-time transfer.