Search results for " control"
Article
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 …
Article
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…
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Analyzing Proteins Using SEC, MALS, and UHPLC
In addition, Pothecary says that characterization of oligomers, which are ordered assemblies of multiple proteins, is important because oligomerization controls protein activity. Measurement of molecu…
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Global Expansion Shapes Drug Oversight
…SP to provide technical assistance to government regulatory systems in establishing domestic quality control laboratories, quality monitoring systems, and effective domestic regulatory authorities.
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Biopharma Moves to Integrated, Single-Use, Downstream Processing
On the smaller scale, Masser also notes that scrutiny by FDA and internal quality control becomes more intense the closer a process step is to the final therapeutic, and as a result there have histori…
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Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
Furthermore, continuous processing facilitates quality control. For instance, many therapeutic proteins are insufficiently stable for batch processing. But with continuous processing, once the protein…
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Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
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2014 Manufacturing Trends and Outlook
Survey respondents represented research, development, formulation, and process development functions, as well as quality control/assurance, validation, and laboratory management titles at branded and …