Search results for " quality"
Article
Biotechnology Innovation and Growth in Israel
In recent years, the Ministry of Health has developed strong capabilities in the areas of health technology assessment (HTA), new technology prioritization, and quality monitoring for community-based …
Article
The Lifecycle Change of Process Validation and Analytical Testing
…s analytical testing (PAT) technologies to support the monitoring and control of product critical to quality attributes. I think material understanding throughout the manufacturing process from the p…
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Automated Concentration and Diafiltration of Multiple siRNA Samples
Controlled, systematic, quality small-interfering RNA (siRNA) production is the core of any successful RNA therapeutics program. To effectively screen potential targets for in vivo activity, it is nec…
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Sterilization Trends for Single-Use Consumables
… the control of irradiation processes rather than just trusting the supplier-provided certificate of quality claiming sterility for SU consumables. The driver behind this trend stems back to a Form 4…
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Address the complexity of protein characterization
During development and quality control, you may use a range of analytical technologies to characterize biotherapeutic drugs in terms of their structural integrity and activity. This presentation inclu…
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Reviewing the Importance of Biosimilarity and Interchangeability
Analytical methods should thus be chosen or developed to compare critical quality attributes (CQAs) between the biosimilar and the reference product. “This involves assessing the physicochemical prope…
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Moving Biosimilars Forward in a Hesitant Market
“I feel like what [has been] created is two classes of biosimilars in the US market, where some are judged to be of ‘higher’ quality because they’re interchangeable, which wasn’t the intention. … A be…
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Top Process Development Trends for 2022 and a Look into 2023
While this certificate-level interactive course on quality by design (QbD) covered fundamental concepts such as the principles of design space and establishing control strategies. Question-and-answer …
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Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing
While some initiatives predated the COVID-19 pandemic, the ongoing health emergency has elevated the importance of collaboration to speed biomedical research efforts and to ensure broad access to qual…
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Implementing Inline Conditioning to Advance Process Intensification
This required integrating new processes like IC calculations, quality management of real-time buffer release, stock solution stability, and so on. Another challenge was the validation of the inline pr…