Technology Transfer: Best Practices in Operational Development

When a customer approaches a contract development and manufacturing organization (CDMO) to gain technology transfer support, it is important to confirm that the CDMO has a proven history and a robust project management and technical platform in place. People and communication are key to project success To ensure that the technology transfer is successful, the project leader will establish a cross-functional team comprising subject matter experts (SME) for each function. Proactive risk management and a 'right-first-time' mentality The ultimate goal of technology transfer is to deliver the new medicine, at the highest quality, to the patients who need it, when they need it; therefore, the final process must be repeatable and well controlled. While drug product development scientists typically work on formulation development and stability improvement in Phases I and II of clinical trials, manufacturability is not always a priority.