Trace metals are supplied to chemically-defined media (CDM) for optimal Chinese hamster ovary (CHO) cell culture performance during the production of monoclonal antibodies and other therapeutic proteins. However, lot-to-lot and vendor-to-vendor variability in raw materials consequently leads to an imbalance of trace metals that are supplied to CDM. This imbalance can yield detrimental effects rooted in several primary mechanisms and pathways including oxidative stress, apoptosis, lactate accumulation, and unfavorable glycan synthesis.
View Article and Find Full Text PDFChinese hamster ovary (CHO) cells are widely used in producing monoclonal antibodies (mAbs), however, these cell lines can show variants associated with productivity and growth. Fundamental understanding of cellular mechanisms can benefit high mAbs production while maintaining robust cell growth. In this study, RNA sequencing (RNA-seq) based approach was used to study the transcriptomic space among three mAb-producing CHO cell lines.
View Article and Find Full Text PDFThe application of PAT for in-line monitoring of biopharmaceutical manufacturing operations has a central role in developing more robust and consistent processes. Various spectroscopic techniques have been applied for collecting real-time data from cell culture processes. Among these, Raman spectroscopy has been shown to have advantages over other spectroscopic techniques, especially in aqueous culture solutions.
View Article and Find Full Text PDFThis is an "11 factor-2 level-12 run" Plackett-Burman experimental design dataset. The dataset includes 11 engineering bioreactor parameters as input variables. These 11 factors were varied at 2 levels and 23 response variables that are glycan profile attributes, were measured "A Design Space Exploration for Control of Critical Quality Attributes of mAb" (H.
View Article and Find Full Text PDFA unique "design space (DSp) exploration strategy," defined as a function of four key scenarios, was successfully integrated and validated to enhance the DSp building exercise, by increasing the accuracy of analyses and interpretation of processed data. The four key scenarios, defining the strategy, were based on cumulative analyses of individual models developed for the Critical Quality Attributes (23 Glycan Profiles) considered for the study. The analyses of the CQA estimates and model performances were interpreted as (1) Inside Specification/Significant Model (2) Inside Specification/Non-significant Model (3) Outside Specification/Significant Model (4) Outside Specification/Non-significant Model.
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