Search results for " quality" in Articles / App Notes
Article
Securing the Single-Use Supply Chain
… the systems and components must be purchased from a supplier, according to John Briggs, director of quality, regulatory, and compliance at ASI-Life Sciences. As a result, adds Mario Philips, vice-pr…
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2014 Manufacturing Trends and Outlook
Survey respondents represented research, development, formulation, and process development functions, as well as quality control/assurance, validation, and laboratory management titles at branded and …
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Biosimilars Development and Supply: How Complex Can the Process Be?
It takes significant expertise and experience to ensure a consistent level of precision in the manufacturing process for a biological product and the key to such precision involves investing in qualit…
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Optimizing your Cell Culture Process to Improve Productivity
It could also be used to analyze monoclonal antibody protein quality by examining the parameters, supplements, and feed timings, which may help increase the quality of the protein being produced in cu…
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What is process development?
Those activities must be combined with the right analytics, so you can accurately measure what you’ve identified as your product’s critical quality attributes (CQAs) as you develop and refine your pro…
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Cell-free Expression Systems Pose Cell Culture Alternative
…al, bypasses limitations on molecular transport across the cell wall, and enables consistent product quality by avoiding stochastic cell growth issues, the professors comment. In addition, Jewett not…
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Genetic Vaccine Platforms Demonstrate Their Potential
“The availability of trained, regulatory-compliant GMP manufacturing staff and quality control and quality assurance personnel is a critical success factor,” he says. Much investment in facilities wil…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Workflows, capital and operating expenses, product quality, and waste production can all be positively impacted by the efficiency gains possible with process intensification.
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How To Execute Successful Data Migrations
By taking proactive steps to fully plan, scope, design, and develop a formal quality assurance (QA) approach, a team will be poised to make their next migration a great success.
The importance o…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Single-use systems involve a greater reliance on the quality and robustness of the vendor’s supply chain, and concerns about potential problems caused by extractables and leachables, especially during…