Technology Transfer Support

Technology transfer is where many quality and supply problems originate. Process understanding that is implicit and reliable at the originating site can quietly leak away when a transfer is run as an email thread rather than a governed project. PharmExpert manages product and process transfer — scale-up, site-to-site and CMO transfer — with a structured approach that preserves process understanding and demonstrable control.

We run the transfer as a project with a clear plan, governance and stage gates. The first job is to make implicit knowledge explicit: capturing not just procedures but the control strategy, critical parameters and the rationale behind them, so what moves is genuine understanding rather than a recipe.

At the receiving site we manage characterization, comparability and validation to confirm the process performs equivalently, and we assess and close the gaps that scale or a different facility inevitably introduce. Comparability is demonstrated with data, not assumed.

The transfer closes only when it has met its predefined criteria, with documentation that withstands inspection. Whether you are scaling from development to commercial, consolidating a network, or moving to a CMO, the outcome is a transferred process that is robust, comparable and ready to run.