Scaling up and Industrializing the Production of Viral Vectors and Cells for Therapeutic Use

Cell and Gene Therapies have the potential of revolutionizing medicine in the 21^st Century. Bioprocessing the therapeutic agents for these therapies still face many challenges during scale up. The utilization of scale down unit operations from bioreactors to downstream purification is very useful in defining the design space and preventing costly scale up errors. Case studies will be presented to demonstrate the challenges and solutions associated with process development of such therapeutics. Optimization for adherent cells cultures in two different platforms – microcarriers and flatware – is presented. The cultures are scaled up to industrial scale for both platforms. Optimal conditions for the production of viral vectors in fixed bed bioreactors are determined through DOE’s and scaled up according to the scaling rules associated with these type of reactors. Purification development and scale up for these vectors are presented.