What Should You Consider When Scaling Fill/Finish for Cell and Gene Therapy?
Transitioning from lab manufacture to commercialization presents significant challenges, no matter what area you’re working in. Cell and gene therapies are no different and production quantities must scale at multiple stages, first to support clinical trials and then when they reach the market. With uniquely challenging conditions required to protect medicinal integrity and exceptionally high value products this growing therapy class offers new challenges, but a combination of new technologies and a forward-thinking approach can help to mitigate these.