Search results for " control" in Articles / App Notes
Article
Essentials in Quality Risk Management
An effective QRM process can further ensure the high quality of the drug product to the patient by providing a proactive means to identify and control potential risks to quality during development and…
Article
Regulatory Challenges in the QbD Paradigm
This decline in success rate, along with the increasing scrutiny of healthcare costs in developed economies, has resulted in unrelenting pressure on the pharmaceutical companies to control drug-develo…
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Moving PAT from Concept to Reality
In-line and on-line sensors allow for continuous process measurement and control, while at-line measurements cause a delay between sampling and availability of the results, preventing their use for di…
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Using Quality by Design to Develop Robust Chromatographic Methods
48-64
The quality-by-design principles that enable a manufacturer to limit and control the sources of process variability are equally important to measurement systems, because the variability in …
Article
Setting Up Bioprocessing Systems for Digital Transformation
Given the large-scale switch-over to single-use components in biopharmaceutical manufacturing, there is an urgent need to have greater control over manufacturing operations with single-use components,…
Article
Remote Monitoring and Big Data Advance Upstream Automation
Specific examples include the adoption of single-use systems, particularly mobile systems designed for ballroom manufacturing and solutions that address the unique process control challenges associate…
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Using Software in Process Validation
It seems straightforward, but how does one achieve this when it involves a myriad of multiple systems (programmable logic controllers [PLCs], human-machine interfaces [HMIs], control systems, etc.) an…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
…ding of product quality attributes serves as the touchstone upon which process design and integrated control strategies are built.
Structural characterization is used to assess the CQAs of bioph…
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Quality by design for biotechnology products—part 1
…setting specifications, followed by the development of the design space and establishing the process control strategy; to later stages, including incorporating QbD into a regulatory filing and facili…
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
A small-scale version of controlled freezing-thawing systems is useful for scale-down assessment of freeze-thaw process characterization (37). The authors, therefore, sought to assess the feasibility …