Search results for " quality"
Article
New Era for Generic Drugs
Henry Waxman (D-Calif), who is retiring from Congress but continues to urge vigilance to ensure that Americans retain access to low-cost quality medicines.
A September conference commemorating Hatc…
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Design of Experiments for Analytical Method Development and Validation
Design of experiments (DOE) is a well-proven characterization approach within product and process development and a key aspect of quality by design. Recently, more attention has been placed on applyin…
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Early Communication with Regulators is Essential for SMEs
To provide an incentive for more SMEs to develop advanced therapies, EMA has set up a scheme for the scientific evaluation and subsequent certification of the quality and, where necessary, non-clinica…
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Essentials in Establishing and Using Design Space
Design space is generally considered to be the areas where the product or process parameters can be run safely (without failure or high amounts of degradation) and achieve all critical quality attribu…
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Evaluating the Use of Continuous Chromatography
As the biopharmaceutical industry strives to demonstrate, continuous manufacturing offers the benefits of higher productivity and better product quality than traditional batch manufacturing. In additi…
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Maximum Output Starts with Optimized Upstream Processing
“The latest iteration of technologies is being developed with scalability, process intensification, and lean principles in mind to ensure quality and reliability for the life of a process,” he asserts…
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Setting Up Bioprocessing Systems for Digital Transformation
“Today, quality teams must also verify that nobody changed the configuration of the system, which might impact the measurement. It is no longer enough to demonstrate that the temperature value was cor…
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Technology Innovations Improve Process Chromatography Performance
Data can help quality and process optimization engineers gain deeper insight into complex material interactions in downstream process steps, particularly related to raw material characterization, Deor…
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
Also, ChromX offers multiple helpful features, including the ability to facilitate data import from ÄKTA™ systems and finding correlations between process parameters and quality attributes. But t…
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On-Demand Webinar: A Route to Deeper Process Understanding—Studying Resin Variability Using a Process Characterization Kit
Chromatography resin attributes, such as ligand density, can affect critical quality attributes (CQAs) as well as process performance depending on the process design and the separation at hand.
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