Search results for " validation" in Articles / App Notes
Article
Report from the 12th Plasma Product Biotechnology Forum
Important to note, is that the validation of the program is designed to achieve flexibility for use of the intermediates in manufacturing facilities at all CSL Behring sites.
The Future
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Top Process Development Trends for 2021 and a Look into 2022
Another aspect of this is the manufacturing process and its robustness as it pertains to compliance with process validation requirements set forth by the FDA and ICH (International Council for Harmoni…
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Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
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Gunnar Malmquist, Senior Principal Scie…
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Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
By Jennifer Markarian
A digital twin is a model of a proces…
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Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.
By Feliza Mirasol
The advancement of digit…
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Common Challenges in Cross-Functional Process Development
cross functional
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James Blackwell, President, Windshire Group, LLC, explores common challenges in cross-functional process developme…
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Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches.
By Cynthia A. Challener
For a vaccine to be effective, the components of the disease o…
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Remote Monitoring and Big Data Advance Upstream Automation
“The desire to produce ‘batches of one’ presents very special automation challenges when it comes to both automation and batch validation,” he continues. Engineered solutions utilizing closed systems …
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Testa Challenge 2020 Attracts Leading International Bioprocessing Innovators
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Six bioprocessing innovators have successfully completed the inaugural Testa Challenge 2020. Held over an intensive week in the Testa Center located at Cytiva´s Uppsala…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.
By: Pranav Vengsarkar and Nandu Deorkar
I…