Search results for " quality" in Articles / App Notes
Article
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…
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Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
So we do this by looking at the visual quality of fit, by looking at the confidence intervals of these fitted parameters, and of course propagating them through to any model predictions. And finally, …
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FDA Provides Guidance on Bispecific Antibody Development Programs
FDA published final guidance on May 24, 2021 to provide industry and stakeholders with recommendations for the development of bispecific antibodies including recommendations for regulatory, quality, n…
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Traceability in Western Blot Imaging: Considerations for GxP
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Densitometry analysis of gels is a key part of quality control in the pharmaceutical drug release process. In regulated environments, electronic record-keeping can improve both tra…
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Cytiva Advances Fiber Chromatography Technology with New Launch
The product quality is comparable to resin purification and the eluate is more concentrated. This is a great technology that allows rapid [P]rotein A purification and saves precious time, while mainta…
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Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
Variability can be reduced across the biopharmaceutical value chain by characterizing raw materials, monitoring materials quality, and controlling raw material usage.
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Biomanufacturing: Demand for Continuous Bioprocessing Increasing
- Improved quality: Biological molecules are expressed continuously, and compared to batch culture, continuous culture tends to be more controllable, less intense and stressful, including less shear a…