I-Corps: SwiftVax - A Green Manufacturing Platform for Faster, Cheaper, and Scalable Vaccine Manufacturing

拟议的生产平台是一种技术，可以使用非转基因烟草植物作为疫苗的生物工厂，并利用协同工作的3种不同的生物系统：(1)农杆菌可有效转移目标疫苗编码的DNA；(2)植物病毒，提高疫苗产量；(3)非转基因烟草植物作为合成疫苗的宿主。利用烟草作为疫苗生物工厂，取代传统的生产工艺，具有潜在的重大意义。资本和运营成本可显著降低高达90%，而疫苗开发时间可从数月缩短至数周。提出的技术代表了生物技术行业的新兴趋势。FDA现在愿意批准非传统生产系统生产的“生物更好”的治疗药物。Biobetter意味着更快、更高效、更便宜、更环保；与传统技术相比。提案团队在该领域拥有丰富的经验，并且该团队和其他团队在优化方法方面的最新发展使该技术处于商业化和重大社会影响的边缘。最近出现的传染病流行，如H1N1大流行，需要具有成本效益和可扩展的生产技术，这些技术可以迅速向临床环境提供有效的治疗方法。这一概念验证的任务是将该技术平台的快速、可扩展和具有成本效益的疫苗制造能力带到研究实验室之外，更接近市场。这项技术可以影响多种市场，如用于研究的蛋白质以及兽医和人用疫苗，并可以提高全球动物和人类健康的质量和可负担性。重组蛋白作为试剂和/或诊断的生产平台的成功验证和商业化将展示生产平台并开辟新的市场，这与以前的生物制造实践不具有成本效益。

The proposed manufacturing platform is a technology that enables the use of nontransgenic tobacco plants as biofactories of vaccines, and takes advantage of 3 different biological systems working in synergy: (1) Agrobacterium tumefaciens for effective transfer of DNA that codes for the vaccine of interest; (2) Plant virus for increased vaccine yield; (3) Non-transgenic tobacco plants as hosts for vaccine synthesis. Using tobacco as vaccine biofactories, instead of traditional manufacturing processes, is potentially significant. Capital and operating costs can be significantly reduced, up to 90%, while vaccine development time is reduced from months to weeks. The proposed technology represents an emerging trend within the biotechnology industry. FDA is now willing to approve therapeutics manufactured in non-traditional production systems that are "biobetter". Biobetter means faster, more efficient, substantially cheaper, and greener; compared to traditional technologies. The proposing team has deep experience in this field, and recent developments in optimization approaches from the group, and others, have positioned this technology on the brink of commercialization and significant societal impact.Epidemics of recent emerging infectious diseases, such as the H1N1 pandemic, demand cost-efficient and scalable production technologies that can rapidly deliver effective therapeutics into the clinical setting. The mission of this proof-of-concept is to bring the rapid, scalable, and cost-efficient vaccine manufacturing capabilities of the technology platform outside of the research lab and closer to the market. This technology can impact diverse markets such as proteins for research use, as well as veterinary and human vaccines, and can improve the quality and affordability of animal and human health globally. Successful validation and commercialization of this manufacturing platform for recombinant proteins as reagents and/or diagnostics would demonstrate the production platform and open up new markets, which were not cost effective with previous biomanufacturing practices.