The Top Tech Transfer Risks At Multi-Site CDMOs (And How To Mitigate Them With A Single-Site)

By Josh Clark, Senior R&D Engineer, Grace; Steve Halpin, Analytical Services Manager, Grace; and Chris Sprout, Principal Scientist, Grace

The tech transfer stage is a critical and high-risk moment in pharmaceutical development. As a process moves from development into scale up, minor discrepancies across documentation or processes can lead to errors, misunderstandings, and timeline delays. Unfortunately, these challenges only amplify when a sponsor’s active pharmaceutical ingredient (API) needs to be transferred to multiple sites, including within the same contract development and manufacturing organization (CDMO).

When one CDMO leverages multiple sites, a tech transfer requires handoffs between different teams and facilities, each with distinct operating practices and protocols. As a result, the multi-site CDMO model increases the risk of miscommunication, disruption, and lost institutional knowledge. However, a single-site model that operates all facilities and functions on one campus will mitigate these risks via aligned process expertise, analytical insight, and decision making. Download the full article to explore how site structure impacts tech transfer execution and control over quality and timeline.