Search results for "validation"
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
…pecially for smaller companies in the early stages of development at smaller scales, where cleaning validation is not a top priority,” he explains.
Hold-up volumes also become increasingly importa…
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Virus safety challenges: get the job done!
Virus safety is key in bioprocessing. In this free 1-day seminar you’ll learn how to conduct virus filterability trials, including prefiltration.
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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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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
“Opportunities to increase stability that involve substantial revision of the final formulation may require additional and extensive clinical trials to establish efficacy and safety along with revalid…