Search results for " design" in Articles / App Notes
Article
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 …
Article
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…
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Moving Biosimilars Forward in a Hesitant Market
…lsewhere is automatically deemed to be interchangeable with its reference product, similar to the EU designation system. I think that would ease the burden,” Gabrielson says.
Easing the way for m…
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Benefits of DoE vs mechanistic modeling
Hear about the main differences between mechanistic modeling and design of experiments when used during chromatography process development. You will learn that, quite often, these methods work…
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Top Process Development Trends for 2022 and a Look into 2023
While this certificate-level interactive course on quality by design (QbD) covered fundamental concepts such as the principles of design space and establishing control strategies. Question-and-answer …
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Report from the 12th Plasma Product Biotechnology Forum
The program is focused on design and construction of new, standardized, and sustainable base fractionation facilities in Australia and Germany using optimized manufacturing processes and the latest te…