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

SBIR 第二阶段：毕赤酵母生物反应器的连续近红外监测仪

• 批准号: 1058434
• 负责人: Elizabeth Gibson
• 金额: $ 50万
• 依托单位: ASL Analytical, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2015-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1058434&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Continuous; Near

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.

这个小型企业创新研究(SBIR)第二阶段项目将进一步开发一种完全强化的、用户友好的ASL Pichia监视器，用于商业蛋白质生产。第一阶段的工作证明了连续、实时的近红外监测仪在毕赤酵母表达蛋白质期间跟踪代谢物水平和细胞密度的商业可行性。将这项技术应用到工业生产或工艺开发环境中，需要对整个系统进行加固，并使其更加用户友好。所有硬件部件将被整合到一个带有嵌入式计算机的单一单元中，采样接口将得到改进，以允许连续监测或离散采样。将制定校准生成和更新的协议，并开发性能诊断以最大限度地提高校准的稳健性。该仪器的最终设计将由目前的毕赤酵母用户进行Beta测试。这项研究的更广泛影响将使生物反应器得到准确控制，并加强优化工作，从而最大限度地提高毕赤酵母生产高价值蛋白质的产量。ASL连续、实时监测的成功开发将增强毕赤酵母作为蛋白质表达平台的吸引力。毕希亚社区接受该监测仪将加强开发新的生物制药的努力，并缩短药物开发过程。ASL的监测器将通过实现更有效的控制和优化来催化毕赤酵母的使用，从而降低医疗成本，并使这些生物治疗蛋白质更广泛地获得。ASL的核心监测技术将适用于更广泛的市场，应用于生物技术、生物医学和临床环境，目前还无法获得可靠的在线检测。