SPECTROSCOPIC FINGER-PRINTING OF RAW MATERIALS

Herein is reported a method for the selection of cultivation component batches to be used in the cultivation of a mammalian cell expressing a protein of interest wherein at least two different components are employed in the cultivation comprising the following steps: a) providing spectra of differen...

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Bibliographische Detailangaben
Hauptverfasser: GLEDSON EMIDIO JOSE, ULRIKE STRAUSS, CHRISTIAN HAKEMEYER, JÓSE CARDOSO-MENEZES, SILKE WERZ
Format: Patent
Sprache:eng ; spa
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Zusammenfassung:Herein is reported a method for the selection of cultivation component batches to be used in the cultivation of a mammalian cell expressing a protein of interest wherein at least two different components are employed in the cultivation comprising the following steps: a) providing spectra of different batches of a first component obtained with a first spectroscopic method and spectra of a second component obtained with a second different spectroscopic method and the cultivation supernatant yield of the protein of interest obtained in a cultivation using combinations of these different batches of the first and the second component, b) processing the spectra, filtering the spectra, smoothing the spectra, and transforming the spectra to their first derivative, c) identifying patterns in the spectra, d) identifying a relation of the patterns identified in d) with the yield of the cultivation, e) providing a spectrum of a further batch of the first component obtained with the first spectroscopic method and a spectrum of a further batch of the second component obtained with the second spectroscopic method, f) processing the spectra, filtering the spectra, smoothing the spectra, and transforming the spectra to their first derivative, g) selecting the combination of the provided first component and the provided second component if the predicted cultivation supernatant yield based on the relation identified in d) is within +/- 10 % of the mean yield provided in a). La presente invención se refiere a un método para la, selección de partidas de componentes de cultivo que se utilizan en el cultivo de una célula de mamífero que expresa una proteína de interés en donde por lo menos dos diferentes componentes se emplean en el cultivo que comprende los siguientes pasos: a) proporcionar espectros de diferentes partidas de un primer componente obtenidos con un primer método espectroscópico y espectros de un segundo componente obtenidos con un segundo método espectroscópico diferente y el rendimiento del sobrenadante de cultivo de la proteína de interés obtenido en un cultivo utilizando combinaciones de estas diferentes partidas del primer componente y del segundo componente, b) procesar los espectros, filtrar los espectros, refinar los espectros y transformar los espectros a su primer derivado, c) identificar patrones en los espectros, d) identificar una relación de los patrones identificados en d) con el rendimiento del cultivo, e) proporcionar un espectro de una partida ad