Development of a High Performance Bioreactor

描述(申请人提供)：第二阶段项目的具体目标是进行研究，以开发和展示先进的高性能生物反应器(HPBR)发酵技术，以增强各种细胞生物的生长特性和产品表达，例如细菌、真菌、酵母、植物、昆虫和哺乳动物细胞。HPBR基于一种新的低频共振、低剪切混合技术，与传统技术相比，该技术已被证明可提供极大的氧气传输率和显著改善的混合。在第一阶段进行的工作提供了令人信服的证据，证明HPBR是一种改进的方法，可用于广泛的生物体和药品的生长和体积生产力。这项技术既是一种发现工具，也是一种生产生物制药的有效方法。HPBR的主要商业化机会是培养杂交瘤细胞以生产单抗(MAb)。未来10年，MAB的市场预计将以20%的复合增长率增长，达到60亿美元，预计产能将严重短缺。与传统的搅拌式生物反应器相比，HPBR技术在工艺强度上提高了一个数量级。

DESCRIPTION (provided by applicant): The Phase II project specific aim is to perform research to develop and demonstrate an advanced, High Performance Bioreactor (HPBR) fermentation technology that enhances growth characteristics and product expression for various cellular organisms, e.g., bacteria, fungi, yeast, plant, insect and mammalian cells. The HPBR is based upon a novel low-frequency resonant, low-shear mixing technology that has been demonstrated to provide greatly increased oxygen transfer rates and considerably improved mixing compared to conventional technology. The work conducted in Phase I provided compelling evidence that the HPBR is an improved method for the growth and volumetric productivity of a broad range of organisms and pharmaceutical products. The technology has application as both a discovery tool and as an efficient method for production of biopharmaceuticals. The major commercialization opportunity for the HPBR is the culture of hybridoma cells for the production of monoclonal antibodies (MAb). The market for MAb's is projected to grow at a compound rate of 20% over the next 10 years, to $6 billion and serious shortage of production capacity is foreseen. The HPBR technology offers an order of magnitude increase in process intensity compared to conventional stirred bioreactors.