Search results for " knowledge"
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Risk assessments or experiments performed against the ATP should be made each time any change to the product or process is made or new knowledge is gained.
Figure 1: Enhanced science a…
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Evaluating Design Margin, Edge of Failure and Process
It is a best practice and increases product and process knowledge and reduces risk. Using a risk-based and multivariate approach is a best practice in generating the design space. Determination of fai…
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Quality by Design—Bridging the Gap between Concept and Implementation
…erimental models on which QbD approaches are based, are challenging and require advanced statistical knowledge. Common quality assessors and GMP inspectors, however, usually do not have such knowledg…
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Report from the 6th International HTPD Conference
How to educate, how to make more people adopt the HTPD methodology, how to make them trust the results and trust the models, and how to ensure acquired knowledge is maintained.
Beyon…
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How do mechanistic chromatography models work?
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Maximum Output Starts with Optimized Upstream Processing
“Small and newly-established biotech companies often have little to no drug development or regulatory experience, meaning they need supportive partners with the knowledge and capability to bring their…
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
What are the main advantages of using the software?
The nature of mechanistic models requires some amount of expert knowledge. ChromX is suited to facilitate this modeling approach as far as possi…
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Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
According to the press release, JIB offers a range of training programs to advance the skills and knowledge of scientists, engineers, and technicians who work in process development and biomanufacturi…
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Leveraging Computational Models of Glycosylation for Biopharma QA
Advantages of statistical models are that they do not require a priori knowledge of the process, require little or no end-user modeling expertise, and can therefore be deployed with relative ease. Sta…
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Biopharma Seeks Balance
…ons; centralized project management functions and processes within the Office of New Drugs; improved knowledge management; a unified post-market safety surveillance framework to monitor the benefits …