Search results for " monitoring" in Articles / App Notes
Article
Preclinical Evaluation of Product Related Impurities and Variants
Thereafter, monitoring of product quality is performed to demonstrate consistency.
Traditional practice for assessing impact of charge variants on product safety and efficacy involves either us…
Article
QbD Improves Cell-Culture Process Control
Using a QbD strategy that implements PAT offers the advantage of real-time process monitoring and, subsequently, quality control based on the application of multivariate data analysis and mathematical…
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Impact of Media Components on CQAs of Monoclonal Antibodies
Optimal growth of cells requires monitoring and control of process variables such as pH, dissolved oxygen, dissolved carbon dioxide, and temperature. Arguably the most important and -crucial step in c…
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Mechanistic Modeling of Preparative Ion-Exchange Chromatography
For complex unit operations such as process chromatography, mechanistic modeling can assist in developing a systematic approach for process development, monitoring, and control. Models can also be jud…
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Perfusion in the 21st Century
Equipment limitations, such as the lack of good aseptic connectors, marginal pump accuracy, and inadequate on-line monitoring, led to technical problems and regulatory uncertainties. There were questi…
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The Metrics of Quality Culture
Indirect product-quality metrics could include environmental monitoring, water trend results, and yield rates. When establishing site metrics, the company could look at inspection history including in…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Mar 01, 2015
By Randi Hernandez
BioPharm International
Volume 3, Issue 28
Aggregation in biopharmaceuticals remains a major concern and threatens the stability of a product. Protein …
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Verification would typically include routine monitoring (e.g., control charts of the measurement procedure). Such close monitoring of the measurement procedure every time it is run would allow for clo…
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Challenges of Protein Aggregation During Purification
Use of such real-time process analytical techniques for the monitoring and control of product aggregation will need to be justified, however, with the completion of appropriate cost/benefit analyses,”…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Mhatre, “LC-ESI/MS and MALDI-MS for Monitoring of Glycoform-Related Clearance of a Complex Glycoprotein in Cynomolgus Monkeys,” presentation at the 58th ASMS Conference on Mass Spectrometry (Salt Lake…