Search results for " design"
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Optimizing Resin Performance with Disposable Chromatography Solutions
There have not been any major technical changes in the chromatography systems or columns design; however, we are seeing continuous improvement in associated sensor performance, accuracy, reliability, …
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Analyzing Proteins Using SEC, MALS, and UHPLC
Smaller flow cells and improved cell design, for example, have made it possible to connect more detectors together without the negative consequences of significant peak broadening and tailing. “As a …
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
The company received FDA approval for Flucelvax, the first cell-culture vaccine in the US designed to protect against seasonal influenza in individuals 18 years of age and older, in November 2012 and …
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
…ry and higher-order structures, animal models, simulation tools and complex algorithms, expertise in designing clinical trials that target the appropriate end points and do so with as few patients an…
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Predicting Progress in Protein Aggregation
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deuterium exchange mass spectrometry (HDX MS), are enabling the improved design, production, and …
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Best Practices in Adopting Single-Use Systems
… when embarking on a new single-use deployment include materials of construction, components, system design, and vendor support. Neglecting these considerations can result in costly delays and an unc…
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State of Quality and Compliance in the Biopharmaceutical Industry
Among these initiatives are the Pharmaceutical cGMPs for the 21st Century, process analytical technology (PAT), quality by design (QbD), and harmonization of international standards and guidelines.
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Elucidating Biosimilars Characterization
Thus, a classical randomized crossover design as used for small molecules is not appropriate on safety and logistics grounds. Such studies, therefore, are most likely to use a parallel-group design, i…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Several software packages are available that are designed to reduce the time necessary to complete post-data acquisition tasks. For liquid chromatography applications, commercially available chromatog…
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Selected courses from cell culture and downstream process development to scale-up and manufacturing
Examples of available free of charge eLearning courses:
What is quality by design (QbD)?
Principles of cell line development
Bioreactor scaling
Filtration in bioprocessin…