Search results for " control"
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Trends in Single-use Bioreactors
In addition, there are improved control systems that allow multiple unit operation and sophisticated feed strategies improving cell yield and increasing titer with single-use bioreactors. Ergonomic fe…
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Gowning Practices Provide Clues to cGMP Compliance
Appropriate gowning
Is the protective clothing appropriate for the cleanliness level of the area? In production areas designed to be classified as controlled environments (i.e., designed using ISO…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Egg-vaccine technology limitations
Traditional vaccine manufacture begins with a “seed” virus identified and provided by the Centers for Disease Control and Prevention. This virus is introduced …
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Predicting Progress in Protein Aggregation
As the development of biologic drugs based on antibodies and other protein/peptide molecules continues apace, the control and prevention of aggregation during manufacturing, downstream processing, for…
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Biotechnology Innovation and Growth in Israel
Historically, the high price of drugs has not been part of the public debate in Israel, and the government has rarely used price controls as is the case in other countries. However, recent economic st…
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Implementing QbD in Sterile Manufacturing
This is important to control the results of the former activities, as well as to identify and solve any existing problems prior to the start of the drug-manufacturing process. We primarily execute a d…
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ReadyToProcess WAVE 25 Bioreactor System
With ReadyToProcess WAVE 25, the rocking technology is enhanced with features such as advanced sensors and intelligent control strategies. System operation is easily managed via the intuitive and user…
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State of Quality and Compliance in the Biopharmaceutical Industry
QUALITY IMPROVEMENT INITIATIVES
PAT, QbD, Quality, and cGMPs for the 21st Century are meant to provide increased understanding, control, and reliability of manufacturing processes, as well as c…
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Biosimilars Development and Supply: How Complex Can the Process Be?
With expanding demand for good-quality healthcare comes the challenge of controlling healthcare expenditures (1). The goals behind the safe and regulated introduction of biosimilars into the market in…
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Automated Concentration and Diafiltration of Multiple siRNA Samples
The system air sensor controlled sample volumes processed across all inlets. Water from a hydro purification system was used for rinsing, water flux test, flush, and diafiltration steps. Water was use…