High Precision Bioassay Using Robotics and Statistics

使用机器人和统计学进行高精度生物测定

基本信息

批准号：
6882967
负责人：
David Matthew Lansky
金额：
$ 9.98万
依托单位：
PRECISION BIOASSAY, INC
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-02-01 至 2006-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6882967
关键词：
bioassay computer program /software mathematical model method development model design /development robotics statistics /biometry tissue /cell culture

项目摘要

DESCRIPTION (provided by applicant): Cell culture bioassays are perceived as laborious and imprecise even after substantial development efforts. These bioassays are used broadly in the biotechnology industry to measure protein or vaccine products in development and for lot release. Imprecise assays and slow assay development contribute to slow product development. Common practice in cell culture bioassay ignores statistical and regulatory guidance by failing to utilize proper randomization and not accounting for group effects (caused by multi-channel pipettes). In addition, the lack of attention to location effects within the assays combined with simplistic analyses of assay data compromise the precision and efficiency of cell culture bioassays. We propose a modern standardized approach to cell culture bioassay using statistical design and analysis linked to laboratory robots, which will address randomization, location effects, serial dilution, and grouped dilution. The larger program goal is to build a turnkey cell culture bioassay system using statistical software and a laboratory robot. The work described in this proposal will use 1) standardized designs and analysis, 2) linear or nonlinear mixed split- or strip-plot models for bioassay analysis, 3) recent developments in laboratory robotics that make randomization practical (both hardware and software), and 4) new code for modeling serial dilution error (developed under EPSCoR funding, Lansky 2004). The combination of methods, once developed, should reduce the coefficient of variation from high single digits or substantially higher to low single digits, reducing the need for replication by a factor of four to ten or more. Most importantly, by building a turnkey robotic and analysis bioassay system, this level of assay performance will be made broadly available to the biotechnology industry as well as to non-profit researchers.

描述（由申请人提供）：即使经过实质性的发展，细胞培养物生物测定也被认为是费力和不精确的。这些生物测定在生物技术行业中广泛使用，以测量开发和释放中的蛋白质或疫苗产品。不精确的测定法和缓慢的测定开发有助于制作速度的开发。细胞培养生物测定法的常见实践通过未能使用适当的随机分配而不考虑组效应（由多通道移液器引起）来忽略统计和监管指导。此外，在测定中缺乏对位置效应的关注以及测定数据的简单分析损害细胞培养生物测定的精度和效率。我们建议使用与实验室机器人相关的统计设计和分析来实现现代化的标准化方法，该方法将解决随机化，位置效应，连续稀释和分组稀释。更大的程序目标是使用统计软件和实验室机器人建立交钥匙细胞文化生物测定系统。本提案中描述的工作将使用1）标准化的设计和分析，2）生物测定分析的线性或非线性混合分裂或带状图模型，3）实验室机器人技术的最新发展，这些机器人技术的最新发展使随机实用（硬件和软件）以及4）新的代码（4）新的代码，用于建模静脉稀释误差（在Epscor Funding下开发，Lansky 2004年）。一旦开发的方法的组合应将变化系数从高单位数量或更高的单位数字降低到低位，从而将复制的需求减少了四到十倍或更多。最重要的是，通过构建交钥匙机器人和分析生物测定系统，将为生物技术行业以及非营利性研究人员提供广泛的测定性能水平。