Search results for "analysis"
Article
Continuous Manufacturing: A Changing Processing Paradigm
The company’s continuous “Next-Generation Biomanufacturing Facility” uses single-use bioreactors, disposable plastic containers, real-time quality analysis, and also boasts modular design. It is expec…
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The Bullish Outlook for Biosimilars
Research and Markets, An essential competitor analysis report on human growth hormones (hgh): biosimilar pricing is not enough, convenience will mandate (October 2008).
14. Pharma and Healthcare I…
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Fermentation for the Future
“From a process perspective, soluble expression is also beneficial for establishing automated bioprocessing with cultivation and purification closely linked and supported by timely analysis,” Reinisch…
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Securing the Single-Use Supply Chain
…les under typical use conditions obtained from two suppliers to Chemic Laboratories for comparative analysis of their extractable/leachable profiles. “Tubing was selected for this exercise because it…
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Optimizing Resin Performance with Disposable Chromatography Solutions
…s, and overhead to pack a glass column on site and prepare it for use in a GMP suite with a similar analysis for the acquisition of a prepacked column. In collaboration with Dr. Howard Levine from Bi…
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New Era for Generic Drugs
Although there is general agreement that in-depth analysis of product structure and function plus pharmacology testing can combine to document similarity, there’s much disagreement over extrapolation …
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Viral Clearance Challenges in Bioprocessing
Comprehensive risk analysis is often effective for highlighting and prioritizing such evaluations to streamline costly virus testing, according to Greenhalgh.
Process representation
Another chal…
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DoE Provides Benefits, but Preparation Is Necessary
Nguyen remarks that using software to automate data collection and extraction of the relevant output parameters for statistical analysis is important. She also stresses that having an understanding of…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Extensive DNA and protein analysis is required to help avoid this problem, and further testing is conducted to ensure that no pathogens from the eggs are transferred to the vaccine. All of this testin…
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Manufacturers Struggle with Breakthrough Drug Development
The regulator understands that evaluations based on limited stability data and provisional specifications could mask safety issues and that permitting manufacturers to shift more CMC analysis and fina…