Search results for " validation" in Articles / App Notes
Article
From Darwin to Recombinant Fc Multimers
…gineering batches to monitor manufacturing performance, and also contributed to the process control, validation, and regulatory activities.
The third day of the conference opened with the Pathog…
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Advancing Single-Use Technology Through Collaboration
…of the potential risk to quality, as well as a lack of clear understanding of full qualification and validation requirements,” and documents such as this testing protocol aim to remove some of those …
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Process Chromatography Selection for Downstream Processing Applications
are used for one campaign only, omitting the cleaning steps and the need for cleaning validation. There is a continuous development of new chromatography resins combining separation modes. One example…
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Perfusion in the 21st Century
Similarly, changes in market demand can be met more rapidly, while use of disposable equipment reduces capital investment, cleaning and validation costs, as well as equipment footprint. Perfusion is a…
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Single-use technologies in downstream process intensification
When using conventional chromatography solutions, cleaning and cleaning validation consumes a considerable amount of time and facility resources. Cleaning-in-place protocols are performed before, duri…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Late-phase development starts from the manufacture of product for the first registration dose (FRD) using commercial manufacturing processes and ends with process validation and submission of the prod…
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Tools for Continuous Bioprocessing Development
…mon elements: use of contract manufacturers, for instance, and a manufacturer focus on discovery and validation. A key difference is that biopharmaceuticals are manufactured using living organisms, w…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Their use is central to most drug-discovery projects, from initial target validation studies, through clinical candidate selection, to subsequent translational studies (7). It is essential for drug-di…
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Fluid Handling in Biopharma Facilities
Disposables could represent a significant benefit in terms of facility design, validation, and investment. This trend will continue to grow as single-use systems increase a product’s speed-to-market a…
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Robust Optimization, Simulation, and Effective Design Space
Step Eleven: Verify the small-scale and at-scale results
Verification and validation (5) runs at the robust optimum are performed to verify the model prediction and the actual measurements are…