Search results for " system" in Articles / App Notes
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Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems
In a validated GMP process, filters must be routinely tested for integrity. The automated test instruments that are used for filter integrity testing have been improved over the past 40 years. …
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The Smart Benefit of Digital Systems in Preclinical Studies
The advancement of smart drug development reaches far back in the drug development cycle, starting at the R&D phase and moving through the pipeline through to clinical studies. Data gathering…
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A Q&A With Parrish Galliher About Adopting Single-Use Systems
This week, Process Development Forum speaks with Parrish Galliher, Chief Technology Officer Upstream at Cytiva, about trends within the bioprocess area.
What’s one of the biggest t…
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Best Practices for Data Integrity
These investments usually occur in the form of additional manual document reviews, more rigorous quality documentation, hiring more personnel, implementing electronic systems, and so on.
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Modular Manufacturing Platforms for Biologics
Modular systems can refer to a variety of different physical configurations, which can be a source of confusion. Whether something is called a pod or module seems to largely depend on where the unit i…
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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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Single-Use Technologies Prove Effective for Viral Vector Process Development
These technologies provide several advantages over stainless-steel systems, including reduced capital investment, elimination of cleaning in place (CIP), and cleaning validation. These advantages, acc…
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The New World of Biopharmaceutical Manufacturing
Single-use technologies
PharmTech: What have been the most significant advances in single-use systems for biopharmaceutical manufacturing in the past 40 years?
Langer (BioPlan As…
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Monitoring and Control of Inline Dilution Processes
…intensify the production environment, agrees Gerard Gach, chief marketing officer for the Bio/Pharma Systems Group of YMC Process Technologies. “The advent of buffer concentrates delivered in single-…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
…ocesses and facilities and minimize the risks associated with making significant changes to existing systems.
Aging facilities attract FDA attention
Just as time passes more quickly as people…