Search results for " monitoring" in Articles / App Notes
Article
Tools for Continuous Bioprocessing Development
However, advances in microbioreactors are occurring, as the following examples demonstrate:
• pH and DO monitoring are increasingly being integrated at microscale (4,5), as disposable and non-invas…
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Continuous Manufacturing: A Changing Processing Paradigm
An agency representative said at an International Forum and Exhibition on Process Analytical Chemistry Annual Meeting in 2012 that the on-line monitoring characteristic of continuous processing can fa…
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Tackling Analytical Method Development for ADCs
“A good example for ADCs is the assay for monitoring any residual-free drug equivalents,” she comments. “Typically, this method is first developed for either the drug or drug linker used in production…
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Viral Clearance Challenges in Bioprocessing
Facility design and process monitoring
Conditions throughout the commercial manufacturing process must be constantly monitored to avoid viral contamination events. One major concern for biologics p…
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Global Expansion Shapes Drug Oversight
…ance to government regulatory systems in establishing domestic quality control laboratories, quality monitoring systems, and effective domestic regulatory authorities.
Efforts to harmonize pharmac…
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PDA's Technical Report for Biotech Cleaning Validation
49 include change control, risk-based periodic monitoring, and data trending review. Training and retraining for manual cleaning processes are also significant because they are the primary mechanisms …
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Evaluating the Use of Continuous Chromatography
However, the biopharma industry needs to enhance monitoring and control strategies to realize these benefits as current chromatography control strategies remain limited, leading to sub-optimal process…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
A fit-for-purpose facility design leveraging state-of-the-art technologies such as centralized building sensors, monitoring, and control for greater connectivity and single-pass-through air, meanwhile…
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Maximum Output Starts with Optimized Upstream Processing
Development of rapid analytical methods; the use of robust inline, online, and at-line monitoring and testing capabilities to reduce the reliance on end-product testing, exploration of accelerated reg…
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Virus-like Particles as Therapeutic Moieties of the Future
Solution competitive ELISA tracks the correct display of epitopes on VLPs with a neutralizing monoclonal antibody against the respective epitope, which allows real-time monitoring of relative antigeni…