Search results for " monitoring" in Articles / App Notes
Article
Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
This opens a wide range of model applications—from early-stage process development via process characterization to process monitoring and control.
GoSilico has developed the ChromX™ software. What…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
“In the latter case, for instance, consideration must be made for total HCP levels per regulatory guidance, but also for any single HCP of particular concern, for which a more specific monitoring appr…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Bioreactor monitoring is also considerably more complex with continuous processing. Compared to traditional fed-batch processes, which typically require at-line and off-line sampling only once or twic…
Article
Mapping a Route for Cell and Gene Therapy Process Development
…aracterization (potentially due to the numerous process variables and lack of appropriate in-process monitoring and controls) are the main challenges for process validation, according to Baghbaderani…
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Cell-Culture Advances Test Bioreactor Performance Models
“These models also support data-driven decision making for impacted lots, and we continue to develop monitoring strategies through predictive models, near-real-time monitoring, and material-control st…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
SPR is a well-established technique for detection and monitoring of biomolecular interactions in real time. It has been formatted as a parallel line assay and researchers have demonstrated high levels…
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Optimizing Late-Stage and Commercial Cell-Culture Processes
There is also an increasing emphasis on inline monitoring of nutrients/metabolites and at-line monitoring of product quality attributes, adds Dr. Rajesh Beri, technical director biomanufacturing, Lonz…
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Biopharma Seeks Balance
FDA reports that it has considered emerging technologies for biological molecules including controlled ice nucleation for lyophilization processes, predictive modeling for process monitoring and close…
Article
CoAs Help Secure the Supply Chain
CoAs Help Secure the Supply Chain
Certificates of analysis can be used to monitor the reliability of products and their suppliers.
By Susan J. Schniepp, distinguished fellow at…
Article
Single-use Bioreactors Have Reached the Big Time
Meanwhile, glucose and lactate sensors are useful for determining glucose feeds and monitoring cell metabolism, respectively. “With the range of disposable sensors now available, it is possible to obt…