Search results for " design"
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
The resultant operational ranges have traditionally been either very narrow because of lack of supporting experimental studies or statistically derived with little to no data from experimental design …
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Quality by Design and Extractable and Leachable Testing
If harmful leachables are found during stability studies, one would have to step backwards toward product design stages, choose new materials, and qualify them.
FDA Guidance for Industry, Q8 (R2…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
The workflows of a cell therapy or a gene therapy differ from each other and from those of therapeutic antibodies, so the design and layout of the manufacturing facility must take these workflows into…
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Quality by Design—Bridging the Gap between Concept and Implementation
…ssifying of criticality, levels of details required in process descriptions and in risk assessments, design-space verification, and changes to non-critical process parameters (non-CPPs).
Other …
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Right the First Time: Bioreactor Scale and Design Translation
Cell culture processes need to operate in a design space where the oxygen supply and carbon dioxide removal can match cellular metabolism. In addition, prohibitive high shear stress and high gas flow …
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e-Learning: what is quality by design (QbD)?
Key learnings:
- Fundamentals of the QbD concept
- How QbD fits within process development and process characterization
- Key aspects of QbD, such as the principle of design space and est…
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Increase Efficiency in Experimentation with Design of Experiments
Learn more about how to benefit from DoE study setups from the handbook Design of Experiments in Protein Production and Purification.
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Handbook: Design of Experiments in Protein Production and Purification
Modern software is used to create the experimental designs, to obtain a model, and to visualize the generated information.
In a protein research lab or during process development, a DoE approach …
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Increase Efficiency in Experimentation with Design of Experiments
Setting up an efficient study can help you save time and allow you to get the most out of screening and optimization experiments during method development. Also, good planning and relevant experimen…
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Single-Use and Continuous Processing Technologies Change Facility Design
Facilities in use today and built during the past decade would easily be recognised by the original engineers who started this industry in the mid-1970s, whereas facilities designed now are beginning …