Search results for " attribute"
Article
Eliminating Residual Impurities Starts with a Strategic Plan
“Critical quality attributes will be identified during this risk-assessment step and their criticality addressed from a safety perspective. Efficient purification processes will be designed and valida…
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Good Manufacturing Practices: Challenges with Compliance
When a company can design processes that consistently meet all product quality attributes, then this not only meets the base expectations provided in the GMP regulations, it is actively pursuing excel…
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Improving Upstream Predictability
At the contract development and manufacturing organization Lonza, at-line and on-line sensors have improved control of critical quality attributes, says Mohindra. The company is using in-line sensors …
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Risk Assessment: Studying Chromatography Resin Variability
This article focuses on process robustness and the impact of chromatography resin attributes as well as how to identify which parameters and interactions to focus on in your process characterization s…
Article
Monitoring and Control of Inline Dilution Processes
Monitoring and control
When looking at the buffer preparation process, the target product profile should be defined first followed by critical quality attributes and critical process par…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
And then, finally, a digital solution encompassing electronic batch records, process monitoring, scheduling, and other key process attributes should be designed-in early to add efficiency and control …
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Emerging Therapies Test Existing Bioanalytical Methods
This leaves investigators asking questions about how to demonstrate the key bioanalytical attributes specified in the guidance, namely demonstrating that the method measures the intended analyte, eval…
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Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
At the recent Biotherapeutics Analytical Summit, Fredrik Sundberg presented the importance of implementation of a robust analytical control strategy to ensure drug product efficacy and patient safet…
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Webinar On Demand: Expanding SPR Uses in Antibody Effector Function Determination
Critical quality attributes (CQAs) are fundamental to regulatory compliance. CQAs typically include data on how the candidate interacts with target proteins, as well as process-related CQAs such as pr…
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Are You in Control of the Quality of Your mAbs?
Better biotherapeutic characterization for improved quality control
At the recent WCBP conference in Washington, D.C., Dr. Stuart Knowling from Antibody Analytics presented how the latest innovati…