Search results for " process validation"
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
Mechanistic modeling is considered a part of smart process development, which is a collection of approaches to get better process outcomes and speed up process development.
This week, Bioproce…
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Discovering the unknown: How does in silico process development change PD scientists’ work?
In silico process development for chromatography is a paradigm-shifting approach that redefines the routine work of process development scientists. But what does it actually mean to perfor…
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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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Evaluating Design Margin, Edge of Failure and Process
Measures of process capability may be determined during development and confirmed during confirmation batch runs and formal process validation (5).
Cpk is a Poor Measure of Capability
Cpk has …
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Creativity and collaboration are required to overcome complex method development challenges.
By Kelvin H. Lee and Mark Lies
…
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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…
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
In fact, the top 2018 article was the first of a three-part series covering process validation, defining key terms and exploring why process validation is necessary. The other two parts of this series…
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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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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
The aim of this white paper is to demonstrate how Cytiva single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vacci…
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Monitoring and Control of Inline Dilution Processes
Buffer management has received less attention in process intensification despite the high costs and labor-, space-, time-, and material-intensive nature of this common downstream activity.
By…