Search results for " Lifecycle"
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Upstream Processing: Biochemicals and Raw Materials
Experts reveal how to identify the “right” biochemical, the process of sourcing biochemicals, sourcing challenges, and what industry professionals should know about the space.
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
And when it comes to PAT implementation, it will go through a lifecycle where it's developed in the laboratory, tested in a scale-up laboratory, and then eventually, it works its way into a larger com…
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Maximum Output Starts with Optimized Upstream Processing
“The paradigm shift only occurs with reimagining the way we’ve worked previously, and this reimagining is required at all functional nodes of the product lifecycle and through the end-to-end supply ch…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Specific components of a good plant management system include electronic batch record capability, role-based recipe management that optimizes each stage of a recipe lifecycle, data integrity features …
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Eliminating Residual Impurities Starts with a Strategic Plan
“A lifecycle management system for the risk assessment of process-related impurities should be in place that includes and evaluates relevant changes in regulatory requirements (e.g., changes in guidel…
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Good Manufacturing Practices: Challenges with Compliance
WrightStudio/Stock.Adobe.com
The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
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Flexible Facilities for Viral Vector Manufacturing
BioPhorum Group, “Improving the Biomanufacturing Facility Lifecycle Using a Standardized, Modular Design, and Construction Approach,” White Paper, June 2019.
3. Cytiva, “New KUBio Box for Viral Ve…
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Emerging Therapies Test Existing Bioanalytical Methods
…nt in identifying and securing a sufficient and well-characterized supply of reagents to support the lifecycle of all bioanalytical methods.
qPCR is used to quantify a viral genome in serum, tiss…
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A Look into the Future of Biopharmaceutical Quality
I think this phenomenon is more of an issue today than in the past because science innovations are occurring at a much more rapid pace and affecting all aspects of the drug product lifecycle than 20 y…
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Understanding Validation and Technical Transfer, Part 2
Part 3 of this series will discuss validation of a non-traditional biopharmaceutical process, lifecycle, and change management and offers a summarization of the benefits of well-conceived and executed…