Search results for " control" in Articles / App Notes
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
… conveyance, and retention of manufacturing knowledge to improve technology transfer, which provides controlled publication and distribution of manufacturing system standards and operational best pra…
Article
Vaccine Development and Production Challenges Manufacturers
Proposals seek to tighten timelines for the Centers for Disease Control and Prevention (CDC) to recommend new vaccines, for FDA to expedite vaccine exports, and for the National Institutes of Health (…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
FDA notes that changes to protein chemistry that may otherwise be well controlled in other environments “may occur in vivo in the context of the relatively high pH of the in-vivo environment or in inf…
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Technologies and Practices Must Evolve to Meet Demand
The respondents reported that they were involved in many phases of drug development and manufacturing including process development, drug-substance and finished product manufacturing, quality control,…
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Optimizing Resin Performance with Disposable Chromatography Solutions
Customers have expressed that they feel they have less control over this step if an external supplier performs the packing, rather than it being done in-house. However, once customers start using prep…
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Viral Clearance Challenges in Bioprocessing
In these cases, close monitoring of the process, preferably using automated systems, and a good quality assurance/quality control program are essential for preventing such problems, according to Zhou.…
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High-Throughput Process Development in an Historical Environment
Several new equipment and innovations were introduced to the market, such as micro bioreactors in the 10-15 ml scale, controlled by an automated workstation. As an example of their utilization, Chris …
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Application of Quality by Design to Viral Safety
Nevertheless, the industry is moving toward a standard requiring a greater degree of understanding and control over manufacturing processes.
Each unit operation is likely to contribute to or impac…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Examples of such tools include high throughput process development, computational fluid dynamics, and use of advanced statistical approaches for designing experiments, analyzing data, and process cont…
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A Q&A With Parrish Galliher About Adopting Single-Use Systems
Agencies are giving the go-ahead and recognize the benefits for a manufacturing quality control perspective. In addition to Shire HGT in the U.S., there are commercial plants now licensed or going com…