Search results for " monitoring"
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Real Time Continuous Microbiological Monitoring
The nonviable particulate monitoring program plays an important role as it is used on a routine basis to verify the maintenance of air classifications. It is a common assumption that if fewer total pa…
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Remote Monitoring and Big Data Advance Upstream Automation
Increased interest in PAT has, in fact, driven an uptick in the use of inline sensors for real-time monitoring to maintain control of high-quality bioprocessing and improve data analytics, according t…
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Monitoring and Control of Inline Dilution Processes
To ensure robust performance, system blending, flow control, and monitoring of critical parameters must be considered,” she asserts.
Another important factor for consideration, according to Vermun…
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News: Cytiva Adds ELISA Kit to End-to-End HCP Monitoring Capabilities
Cytiva is pleased to announce the new Amersham HCPQuant CHO kit, a generic for detecting host cell protein impurities in drug samples produced in CHO cell lines.
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QbD and PAT in Upstream and Downstream Processing
Weber (CMC Biologics): Assuming this question is referring to the monitoring and control of CPPs and not the tools used to actually establish CPPs, the majority of upstream CPPs are monitored online a…
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Assessing Manufacturing Process Robustness
Stage 3, continued process verification of the product includes the following:
Continued monitoring and sampling of CPPs and quality attributes is at the level established during th…
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Continued Process Verification for Biopharma Manufacturing
In its entirety, CPV includes: preparation of a written plan for monitoring a biopharmaceutical manufacturing process, regular analysis of results, documentation of the data collected, analysis of dat…
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Moving PAT from Concept to Reality
For companies that have adopted PAT, these tools are applied for raw material analysis and monitoring/control of process performance, according to Arpan Mukherjee, technical committee coordinator for …
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Re-use of Protein A Resin: Fouling and Economics
Typical parameters that are used for column monitoring include yield, height equivalent to theoretical plate (HETP), impurities in eluate, product quality, and chromatographic profile (19–21). More re…
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Improving PAT for Biologics
…harmaceutical manufacturing is the implementation of process analytical technology (PAT) for ongoing monitoring and adjustment of production processes to ensure the production of biologic APIs with c…