How a small startup was able to scale up, without losing their precious material.

Jeff faced a dilemma: how to complete a large biomanufacturing scale up with the very small amount of material his client gave him. And the stakes were high. His client had spent a lot of time and money developing this potentially revolutionary Alzheimer’s treatment. Any wasted material would put the execution of the clinical trial at risk, and possibly risk the future of the entire program. Jeff knew the process needed to be perfect. So, his team worked tirelessly to find ways to improve the cell culture performance. They examined key process parameters and even completed additional work in the process development laboratory to ensure success. The result was a flawless scale up and, most importantly, a potentially breakthrough drug was able to get into the clinic.Through incredible effort and intensely coordinated activities, the team in Bend delivered nearly two orders of magnitude more material than typical projects before transferring the product to other Thermo Fisher sites to test, fill, and deliver to patients. Despite the change in plans, the right team stepped in to ensure all deadlines were met, and the client got a critical medicine to the patients who needed it most.