Optimizing CDMO Tech Transfer

By Vladas Algirdas Bumelis, Prof., André Markmann, PhD, and Dominic Chow, PhD, Northway Biotech

Technical transfers are a fact of life in pharmaceutical/biopharmaceutical development. Whether a process is being scaled for commercialization, transferred to another contract development and manufacturing organization (CDMO), or reproduced at the same scale at an additional site, pitfalls exist at every step when attempting to replicate a production process.

Companies transferring a process must focus on three key factors: the equipment, the process, and the employees’ knowledge of the product. Obstacles to the smooth transfer differ, and some types of tech transfer are more complex than others. In this article, we discuss the challenges associated with tech transfers and share how Northway Biotech helps customers overcome such challenges at its twin facilities in Massachusetts (USA) and Lithuania (Europe).