Search results for "analysis"
Article
Biosimilars to Drive Modern Manufacturing Approaches
These activities can help refine the manufacturing process, where incorporation of advanced techniques and quality-by-design approaches may facilitate “fingerprint”-like analysis of a biosimilar seeki…
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Protein Characterization Using SEC: Three Webinar Takeaways
The possibility to separate molecules by size under native conditions is powerful in protein analysis. With more than thirty years in protein science, Åke Danielsson, Research Director at Cyti…
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Improving Process-Scale Chromatography
“An automation platform that consolidates process data also allows operators to spend time on more productive tasks, like process analysis, exception handling, and compliance support,” Ljungqvist says…
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Real Time Continuous Microbiological Monitoring
Environmental monitoring trend analysis provides an enhanced way to detect process changes before they impact the product. LIF is an ultrasensitive and rapid microbiological method for air monitoring …
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Modeling Bioreactor Performance
He also notes that multivariate data analysis packages can transform at-line/online/near-line data into process knowledge, particularly the prediction of batch trajectories and outcomes in real time. …
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
A risk analysis can help determine which components and equipment may introduce the largest amount of risk. Steps with higher risks may also warrant an on-site audit to truly understand all facets of …
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Managing Biomanufacturing Capacity Expectations
…ket cost to develop a new compound was found to be $2870 million (in 2013 dollars), according to an analysis by DiMasi et al. that appeared in the May 2016 issue of the Journal of Health Economics (5…
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Platform Approach Speeds Process Development
Analysis of cell line stability and product quality is included to select the best-producing high-quality production clone.
The commonly used host cells for cell line generation are the FDA-accept…
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Careful analysis of the combined effect of both stimuli on the cells and on the subsequent processing of the product, however, is necessary. Apart from concerns raised by the use of proteolytic enzyme…
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Framing Biopharma Success in 2016
Analysis of the pharma industry’s performance in generating return on investment in new drug development revealed a continuing pattern of declining returns, from 10.1% in 2010 to 4.2% in 2015. While t…