This capstone project’s overall objective was to create a commercialization plan for a biotherapeutic which is early in its life cycle; one which is in the discovery and development phase.  This project lays out the path for regulatory approval by the FDA to allow the biotherapeutic into human clinical trials and eventual entry into the market.  I have also provided strategies for scaling-up the biotherapeutic production procedure to large-scale manufacturing, a strategy for marketing the biotherapeutic to multiple groups, and a financial plan which provides the costs for biotherapeutic commercialization along with a strategy on how to gain and distribute funding.