首页> 外国专利> METHOD OF PREDICTING A PERFORMANCE CHARACTERISTIC OF A PLANT OR YEAST HYDROLYSATE AND ITS USE

METHOD OF PREDICTING A PERFORMANCE CHARACTERISTIC OF A PLANT OR YEAST HYDROLYSATE AND ITS USE

机译:预测植物或酵母水解物性能特征的方法及其用途

摘要

The present invention relates to a method of predicting a performance characteristic of a plant or yeast hydrolysate, wherein a plant or yeast hydrolysate sample is measured with 2D fluorescence spectroscopy in powder form. Said method comprises the steps for providing a model based on a predetermined value of a manufacturing parameter of interest. For this purpose a training set consisting of predetermined manufacturing parameter of interest (e.g volumetric productivity parameter, virus titer or cell number) and fluorescence spectroscopic data is used. The fluorescence spectroscopic data is correlated to the values of the manufacturing parameter of interest to obtain a calibration model/model parameters by applying multivariate data analysis. This calibration model is being used to predict the manufacturing parameter of interest for new samples dedicated for the manufacturing process. This prediction is used for a decision to accept or reject the lot which corresponds to the respective sample for use in the manufacturing process or for further evaluation depending on the pre-defined range of the manufacturing parameter of interest. The invention further relates to a method for preparation of a cell culture medium, preferably an animal protein free cell culture medium, a method for cultivating cells, a method for producing a recombinant target protein, a method for producing an immunogenic composition, whereby the above method of predicting a performance characteristic has been used for selecting the plant or yeast hydrolysate to be used in the manufacturing process.
机译:本发明涉及预测植物或酵母水解产物的性能特征的方法,其中植物或酵母水解产物样品通过粉末形式的2D荧光光谱法测量。所述方法包括用于基于感兴趣的制造参数的预定值来提供模型的步骤。为了这个目的,使用了由感兴趣的预定制造参数(例如体积生产率参数,病毒滴度或细胞数)和荧光光谱数据组成的训练集。通过应用多元数据分析,将荧光光谱数据与感兴趣的制造参数的值相关联以获得校准模型/模型参数。该校准模型用于预测专用于制造过程的新样品的感兴趣的制造参数。该预测用于决定接受或拒绝与制造过程中使用的相应样品相对应的批次,或根据感兴趣的制造参数的预定范围进行进一步评估。本发明进一步涉及用于制备细胞培养基,优选无动物蛋白的细胞培养基的方法,用于培养细胞的方法,用于制备重组靶蛋白的方法,用于制备免疫原性组合物的方法,其中上述已经使用了预测性能特征的方法来选择在制造过程中使用的植物或酵母水解产物。

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