SBIR Phase II: A Gram-Negative Bacterial Secretion Platform for Cost-Effective, High-Purity Recombinant Protein Production

The broader impact of this Small Business Innovation Research (SBIR) Phase II project will be felt at the societal, educational, and scientific levels. The cost and time saving potential of this protein secretion technology alone has the ability to better human health and speed new product development. The availability of lower cost manufacturing drugs that reach the market faster has the potential to save the United States a substantial amount of money going forward. A lower cost protein production strain that operates at scale would also support domestic supply chain resiliency and biosecurity. Reducing the cost of manufacturing biologic drugs would make it more economical to re-shore manufacturing of drugs and drug products to the United States from the current low-cost production countries that export to the United States. By manufacturing these drugs in the U.S., this technology could limit future supply chain disruptions caused by pandemics or complications to international trade. Reducing recombinant protein prices would also pave the way for biomanufactured alternatives in areas such as textiles and pave the way for new manufacturing processes in these industries. The proposed project will further develop an innovative bacterial protein secretion platform technology into a commercially viable, cost-effective protein expression platform capable of producing multiple classes of proteins at an industrial scale, while meeting commercial standards of activity and purity. While the platform is capable of generating limited revenue at pilot scale, achieving these Phase II milestones will allow for manufacturing of commercially relevant reagents at an economically feasible scale, while putting into place an industrially viable production and purification process. The proposed project will initially benchmark the capabilities of the platform by developing and optimizing industrial scale manufacturing processes for 3 different classes of proteins. This project wil