Search results for "fermentation"
Article
Quality by Design and Extractable and Leachable Testing
Impact on cell culture might also be important, particularly for single-use fermentation bags, for example, and USP Biological Evaluation, In Vitro (3) would be a reasonable minimal CQA for which to …
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Viral Clearance Challenges in Bioprocessing
“Contaminants typically detected during the fermentation process may enter the purification process under fully continuous production conditions. Other questions must also be addressed: How can a pote…
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Challenges of Protein Aggregation During Purification
Refolding and in-process hold operations
Escherichia coli-based fermentation processes may result in the formation of product trapped as inclusion bodies within the bacterial cell wall. In such ca…
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Single-Use and Continuous Processing Technologies Change Facility Design
Viewing Changes in Pharmaceutical Facility Design
Single-use systems, continuous processing and isolator technology use a smaller footprint. Experts predict how the facilities of the future may …
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
The DNA plasmids are manufactured using conventional fermentation technology (i.e., no eggs) that is scalable, is engineered for maximum expression in the host cells, and can be rapidly produced in la…
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Raw Material Variability
Many of these issues would be upstream in the cell-culture or fermentation step but could also be downstream in purification. The ‘blackbox’ nature of upstream processes makes things doubly difficult.…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
For example, to perform a multivariate study on a fermentation unit operation, additional processing through cell lysis and purification unit operations is needed so that CQAs may be sampled and teste…
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2014 Manufacturing Trends and Outlook
Single-use systems and other technologies drive process efficiencies, but there is room for improvement.
In a recent survey of current trends and practices in biopharmaceutical manufacturing…
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Quality by design for biotechnology products—part 1
Defining design space for biotech products: Case study of Pichia pastoris fermentation. Biotechnol Prog. 2008:24(3):655–62.
19. Godavarti R, Petrone J, Robinson J, Wright R, Kelley BD. Scale-down …