Search results for " analyze"
Article
Successfully Moving Regulated Data to the Cloud
One area where machine learning has been successful is around image analysis, where the time it takes to analyze the image can be reduced alongside the additional benefit of accuracy being improved.
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Factors that need to be analyzed and controlled for biosimilar development. (Figures courtesy of the authors)
Monoclonal antibodies (mAbs) are at present the fastest growing subclass of biophar…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Fluorescently labeled N-glycans are commonly analyzed by separation using high- or ultra-high-performance liquid chromatography (HPLC or UHPLC, respectively) coupled to fluorescence detection (FLR), o…
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Reliability Rooms and the Move to Proactive Supply Chain Management
These centers are designed to analyze data and provide insights for production forecasts, identify planning and risk metrics, and predict trends and areas of improvement across all of the company’s su…
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Development of Purification for Challenging Fc-Fusion Proteins
The samples in the collection plate were then analyzed by an ultraviolet (UV)-vis spectrophotometer and electrophoresis on a chip (Perkin Elmer) in a 96-well format. All experiments were performed at …
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Generating a Fully Processed Antibody
The 24 clones were grown in culture for five weeks, and FGE level was analyzed using a flow cytometry- based assay at four different times throughout the culture. Based on FGE production and consisten…
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Analysis of Glycosylation in Biosimilars
2-AB stacked chromatograms of five separate N-glycan preparations of an antibody analyzed using hydrophilic interaction chromatography. The data demonstrate that reproducible glycan profiles are obtai…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
ICH Q5B (14) recommends that, “segments of the expression construct should be analyzed using nucleic acid techniques in conjunction with other tests performed on the purified recombinant protein for a…
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Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Data generated in the old platform process during the development of the cell-line construction (CLC) procedure for this host were analyzed by the MVDA technique called principal components analysis (…
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Host-Cell Protein Measurement and Control
2D-SDS-PAGE with silver stain or other sensitive staining method, such as Sypro Ruby (Life Technologies, Grand Island, NY), has traditionally been used to analyze complex protein mixtures due to its a…