Scaling-out rather than scaling-up: Enabling Amgen to overcome barriers with advanced therapy commercialisation
Cell and gene therapies offer potential cures for some of the most devastating and challenging conditions of our time. However, patients face delays in accessing the latest innovations, which are often caused by manufacturing or scaling barriers. Amgen approached TTP to help them overcome this challenge when trying to commercialise EPO.
TTP were the first company to scale-out rather than scale-up bioprocessing manufacturing, in partnership with Amgen. Using our experience and expertise in cell and gene therapies, we supported Amgen to move from a small volume of roller bottles to many roller bottles, rather than scaling up to large volume bioreactors.
Together, we designed and built a factory that contained 40,000 roller bottles conducting parallel manufacturing that directly replicated the biology of the small-scale process. TTP combined inventive thinking and experience to solve the challenges from having thousands of individual parts operating as a single system to provide a reliable and robust cell therapy manufacturing solution. Amgen avoided the time-consuming process of redevelopment, and critically revalidation, of the manufacturing process on a new format.
TTP’s heritage in cell and gene therapies equips us to anticipate and solve potential gaps and challenges across the entire development process. Throughout our thirty years of experience, we have helped over 20 cell therapy companies to use disruptive technologies and automation to solve the most demanding commercialisation and scaling challenges.