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首页> 外文期刊>Biotechnology Progress >Fermentanomics: Relating Quality Attributes of a Monoclonal Antibody to Cell Culture Process Variables and Raw Materials Using Multivariate Data Analysis
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Fermentanomics: Relating Quality Attributes of a Monoclonal Antibody to Cell Culture Process Variables and Raw Materials Using Multivariate Data Analysis

机译：发酵经济学：使用多元数据分析将单克隆抗体的质量属性与细胞培养过程变量和原材料相关联

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Fermentanomics is an emerging field of research and involves understanding the underlying controlled process variables and their effect on process yield and product quality. Although major advancements have occurred in process analytics over the past two decades, accurate real-time measurement of significant quality attributes for a biotech product during production culture is still not feasible. Researchers have used an amalgam of process models and analytical measurements for monitoring and process control during production. This article focuses on using multivariate data analysis as a tool for monitoring the internal bioreactor dynamics, the metabolic state of the cell, and interactions among them during culture. Quality attributes of the monoclonal antibody product that were monitored include glycosylation profile of the final product along with process attributes, such as viable cell density and level of antibody expression. These were related to process variables, raw materials components of the chemically defined hybridoma media, concentration of metabolites formed during the course of the culture, aeration-related parameters, and supplemented raw materials such as glucose, methionine, threonine, tryptophan, and tyrosine. This article demonstrates the utility of multivariate data analysis for correlating the product quality attributes (especially glycosylation) to process variables and raw materials (especially amino acid supplements in cell culture media). The proposed approach can be applied for process optimization to increase product expression, improve consistency of product quality, and target the desired quality attribute profile. (C) 2015 American Institute of Chemical Engineers
机译：Fermentanomics是一个新兴的研究领域，涉及了解潜在的受控过程变量及其对过程产量和产品质量的影响。尽管在过去的二十年中，过程分析取得了重大进步，但是在生产文化中对生物技术产品的重要质量属性进行准确的实时测量仍然不可行。研究人员已将大量的过程模型和分析测量结果用于生产过程中的监视和过程控制。本文着重于使用多元数据分析作为监测内部生物反应器动力学，细胞的代谢状态以及培养过程中它们之间相互作用的工具。所监测的单克隆抗体产品的质量属性包括最终产品的糖基化谱以及过程属性，例如活细胞密度和抗体表达水平。这些与过程变量，化学定义的杂交瘤培养基的原材料成分，培养过程中形成的代谢产物的浓度，通气相关的参数以及补充的原材料（例如葡萄糖，蛋氨酸，苏氨酸，色氨酸和酪氨酸）有关。本文演示了用于将产品质量属性（尤其是糖基化）与过程变量和原材料（尤其是细胞培养基中的氨基酸补充剂）相关联的多元数据分析的实用程序。所提出的方法可用于过程优化，以增加产品表达，提高产品质量的一致性并确定所需的质量属性。 （C）2015美国化学工程师学会

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