How Collaborative Preparation Drives Optimal Tech Transfer Execution

By Daniel Aguilar and Jillian Madrid, Mitenyi Bioindustry

Pharmaceutical technical transfer is a critical, high-risk step for drug development, especially for smaller developers facing limited funding and strict regulatory timelines. Any misstep can severely compromise product quality and cause costs to skyrocket. Success requires the receiving unit to maintain quality while simultaneously achieving speed and efficiency. This process must begin with the sponsor providing a well-developed strategy and engaging in a collaborative planning process with the CDMO, ensuring goals and communication remain aligned.

Successful transfers depend on early, cross-functional engagement between all teams. Proactive planning allows the CDMO to conduct a gap assessment and refine process elements. From a project management standpoint, the sponsor and CDMO must collaborate on a shared timeline and establish a risk register to address potential issues. The two main components, the process stream and analytical stream, should run in parallel to avoid delays caused by sequential execution and unplanned changes.

Failure to have a dedicated project manager, a clear CMC strategy, reliable raw material sourcing, or adequate testing methods are common pitfalls that can derail a project. Ultimately, mastering preparation, communication, and adaptability based on the product’s life cycle is essential to a successful, on-time tech transfer.