SBIR Phase II: Continuous Near Infrared Monitor for Pichia Pastoris Bioreactors

This Small Business Innovation Research (SBIR) Phase II project will further develop a fully hardened, user friendly ASL Pichia monitor for commercial protein production. The Phase I effort demonstrated the commercial feasibility of the continuous, real-time near infrared monitor for tracking metabolite levels and cell density during protein expression with Pichia pastoris. Implementing this technology into an industrial production or process development setting requires the entire system to be hardened and made more user-friendly. All hardware components will be incorporated into a single unit with an embedded computer and the sampling interface will be enhanced to permit continuous monitoring or discrete sampling. Protocols for calibration generation and updating will be established, and performance diagnostics to maximize calibration robustness developed. The final design of the instrumentation will be beta-tested by current Pichia users. The broader impacts of this research will enable accurate control of bioreactors and enhance optimization efforts, resulting in maximum production yields of highly valued proteins from Pichia. Successful development of ASL's continuous, real-time monitor will enhance the attractiveness of Pichia as a protein expression platform. Acceptance of the monitor by the Pichia community will enhance efforts to develop new biopharmaceuticals and shorten the drug development process. ASL's monitor will catalyze the use of Pichia by enabling more effective control and optimization, thereby driving down healthcare costs and making these bio-therapeutic proteins more widely available. ASL's core monitor technology will be adaptable to broader markets with applications in biotechnology, biomedical, and clinical settings, where reliable, on-line sensing is currently unavailable.