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Recombinant Human Serum Albumin for Use in Cell Culture

用于细胞培养的重组人血清白蛋白

基本信息

批准号：
7779390
负责人：
NING HUANG
金额：
$ 37.79万
依托单位：
VENTRIA BIOSCIENCE
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-04-01 至 2011-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7779390
关键词：
Address Animals Antibody Formation Bioreactors Bovine Serum Albumin Breeding Cell Culture Techniques Cell Line Cell Proliferation Cells Cereals Child Chinese Hamster Chinese Hamster Ovary Cell Culture Media Data Disease Disease Resistance Elderly Feasibility Studies Feedback Foundations Funding Future Human Hybridomas Laboratories Marketing Names Ovary Patients Performance Pharmaceutical Preparations Phase Plasma Preparation Production Productivity Proteins Recombinants Reporting Rice Risk Safety Sampling Serum Albumin Serum-Free Culture Media Shipping Ships Small Business Innovation Research Grant Source Suspension substance Suspensions Testing Therapeutic Time Transgenes Vaccine Production Vaccines Vero Cells Virus base blood product cell growth cost cost effective culture plates flasks gain of function improved loss of function monoclonal antibody production pathogen phase 2 study programs public health relevance response scale up therapeutic vaccine transmission process

项目摘要

DESCRIPTION (provided by applicant): Plasma-derived human serum albumin (pHSA) or bovine serum albumin are commonly added to cell culture media used in cell culture-based vaccine and therapeutic production, because it enhances cell growth and increases protein productivity. However, the use of pHSA carries the risk of transmission of viruses and emerging infectious pathogens, particularly for those for which no tests are available. Because millions of people are immunized annually with cell culture- based vaccines and millions more require cell culture-based therapeutics for the treatment of various disorders, regulatory agencies have called for a replacement of pHSA in vaccine and therapeutic production with recombinant HSA (rHSA). In Phase I feasibility study, we showed that rHSA from rice can not only be used to replace pHSA but also outperform pHSA by 51% in cell growth enhancement and by 50% in antibody production. In phase II, we will extend the studies in phase I to test the effect of rHSA on cell growth and productivity of hybridoma, CHO and Vero cells in larger scale cell culture with commercial media. We will also attempt to identify which factor(s) is (are) responsible for the superior performance of our rHSA preparation from rice. We will initiate a breeding program to improve the grain yield so to further reduce cost rHSA production. We anticipate that at the end of phase II studies, our project will have addressed the call by regulatory agencies for a safe alternative to pHSA in vaccine and therapeutic production by providing to the market rHSA with superior performance. Public Health Relevance: Safety concerns regarding human-to-human transmission of emerging infectious pathogens from the use of plasma-derived human serum albumin (pHSA) and blood products as an ingredient in cell culture media for cell-based vaccine and therapeutic production exist. Regulatory agencies have called for the replacement of pHSA with recombinant HSA. In response, an inexpensive source of recombinant HSA produced in rice would not only assure a safe alternative to pHSA, but would also allow cost- effective production of cell-based vaccine and therapeutics.

描述（由申请人提供）：血浆来源的人血清白蛋白（pHSA）或牛血清白蛋白通常添加到基于细胞培养的疫苗和治疗生产中使用的细胞培养基中，因为它可以促进细胞生长并提高蛋白质生产率。然而，使用 pHSA 存在传播病毒和新出现的传染性病原体的风险，特别是对于那些无法进行检测的病原体。由于每年有数百万人使用基于细胞培养的疫苗进行免疫接种，并且还有数百万人需要基于细胞培养的疗法来治疗各种疾病，因此监管机构呼吁用重组 HSA (rHSA) 替代疫苗和治疗剂生产中的 pHSA。在第一阶段的可行性研究中，我们表明，来自水稻的rHSA不仅可以用来替代pHSA，而且在细胞生长增强方面比pHSA高51%，在抗体产生方面比pHSA高50%。在第二阶段，我们将扩展第一阶段的研究，以测试 rHSA 对使用商业培养基的大规模细胞培养中的杂交瘤、CHO 和 Vero 细胞的细胞生长和生产力的影响。我们还将尝试确定哪些因素导致我们的大米 rHSA 制剂具有优异的性能。我们将启动育种计划以提高粮食产量，从而进一步降低rHSA生产成本。我们预计，在第二阶段研究结束时，我们的项目将通过向市场提供性能优越的 rHSA 来满足监管机构的要求，在疫苗和治疗生产中提供 pHSA 的安全替代品。公共卫生相关性：使用血浆来源的人血清白蛋白 (pHSA) 和血液制品作为基于细胞的疫苗和治疗生产的细胞培养基中的成分，存在新出现的传染性病原体在人与人之间传播的安全问题。监管机构呼吁用重组 HSA 替代 pHSA。因此，在水稻中生产重组 HSA 的廉价来源不仅可以确保 pHSA 的安全替代品，而且还可以经济高效地生产基于细胞的疫苗和治疗药物。