Search results for " reliability"
Article
Scaling Up Novel Therapies
During initial workflow development, for example, the need to produce material as quickly as possible can override the need to focus on optimizing process simplicity, reliability, and cost-effectivene…
Article
Automating Bioprocesses
To get the reliability and accuracy needed for certain processes, some manufacturers are choosing to use traditional sensors inserted into the process in a plastic, sterile sleeve; these sensors are s…
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Biosimilars to Drive Modern Manufacturing Approaches
Payers and consumers are looking for reliability in production systems to meet the demands of the larger US market, added Sandoz US President Peter Goldschmidt. He and other leaders in the biosimilars…
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Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015
By Jill Wechsler
Pharmaceutical Technology
Volume 39, Issue 4
To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…
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Digitalization: The Route to Biopharma 4.0
Over the past decade, manufacturers have been increasingly using hybrid models (7) as these offer better model accuracy and reliability together with alignment with Industry 4.0.
Similar studie…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
The well-known limitations of flatware in terms of scalability, reliability, and process optimization have caught the attention of end-users, however. “Scaling-out to achieve large quantities of viral…
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Setting Up Bioprocessing Systems for Digital Transformation
As these data become a key part of the process control strategy, there is increasing focus on control system reliability through the risk of batch failure if the monitoring and control systems fail du…
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Cell-Culture Advances Test Bioreactor Performance Models
The evolution of cell-culture technology is driving the need for improvements in modeling solutions.
By Cynthia A. Challener
Modeling and simulation are recognized to provide assistance i…
Article
Emerging Therapies Test Existing Bioanalytical Methods
…ements that provide reliable data, and the effect of sample collection, handling, and storage on the reliability of data.
Gene therapy assays
For gene therapy programs, one of the first consi…
Article
Using Multiple Techniques in Biosimilar Analysis
Application of multiple techniques at different conditions presents a more complete picture of a dynamic situation.
By Rebecca Strawn
Sergey/stock.adobe.com
Almost all drug product…