Search results for " control"
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
STRs offer several advantages: they are scalable and the principles by which to do so are well known, they offer precise and reproducible control of the culture conditions, and they are highly automat…
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Genetic Vaccine Platforms Demonstrate Their Potential
Moreover, the virus propagation or the production of the antigens are biochemical processes that need to be run under controlled conditions and that may take a long time (weeks to months),” Becker obs…
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High-Quality Chromatography System Meets Predesigned DeltaV for Integrated Manufacturing
Implementing a distributed control system for facility-wide control of biomanufacturing can help overcome these issues by supporting the industry with improved data management and quality control.
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Reimagining Affordable Biosimilars
Furthermore, adequate process controls to monitor and control product quality are necessary for receiving regulatory approval. Ultimately, this situation creates a burden on the manufacturer to invest…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
“A combination of primary (process design), secondary (facility design and operation), and procedural controls and studies should be used,” states Husain.
Stoll identifies three key approaches to …
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Good Manufacturing Practices: Challenges with Compliance
Cohen (Lubrizol): There are various regulations and guidelines around the world regarding the manufacture of biologics, which include information about control of feedlots and cell lines. These addres…
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What’s New in Upstream Technologies
Additionally, the new sensor technologies and the transmitter are fully compatible with the Emerson DeltaV control system.
Buffer delivery component
MilliporeSigma’s BioContinuum Buffer Delive…
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Scaling Up Novel Therapies
Bioreactor manufacturers now integrate analytical technologies such as sensors, which allow better prediction and control of changes between scales, into their products. Chromatography and filter manu…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
UND is undigested control. M3 is conserved trimannosyl core N-glycan.
While exoglycosidases ensure the highest accuracy in glycan structure determination, there have been several historical pro…
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Unifying Continuous Biomanufacturing Operations
…balanced with potential new errors related to handling disposable perfusion equipment and the proper control of perfusion.
Karst et al. highlighted a compelling reason to consider adoption of con…