Search results for " report" in Articles / App Notes
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
How can technology advances resolve data integrity problems?
Data integrity is a major focus of FDA; the agency routinely cites firms in warning letters for failure to accurately record, report, a…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Those may include antibody-dependent cellular toxicity (ADCC), complement-dependent cytotoxicity (CDC) assays, reporter assays, and potency assays. Technologies used typically include ELISA, electroch…
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Single-Use Extractables and Leachables: Cytiva's Alignment with the BPOG Protocol
The need for a standard approach both to the generation and to the reporting structure of extractables data becomes obvious. In this environment, BPOG has published a proposal for such a standard appr…
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Biosimilars to Drive Modern Manufacturing Approaches
The Ohio Public Employees Retirement System reported at the conference that its drug program formulary has added a tier for biosimilars and generic specialty drugs, with a maximum $100 copay for the l…
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Improving Process-Scale Chromatography
While there are no approved downstream processes using continuous chromatography yet reported, according to Ljungqvist straight-through processing (STP), in which two or more chromatography steps are …
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Defining Risk Assessment of Aseptic Processes
Your management is correct to be concerned when there is a reported increase in the number of viable organisms in the environment. It is often difficult to determine where a potential microbial ingres…
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Real Time Continuous Microbiological Monitoring
It is important to emphasize that with the LIF-based monitoring instruments, the data are reported in biologic/fluorescent counts, not CFU. If a trend is observed in the air microbial sampler, however…
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Innovation vs. Capacity: How CMOs Compete
Several CMOs have reported revenue declines resulting from lost tenders in recent years. There is a similar process going on in Japan.
There are two areas where capacity-driven CMOs have promising…
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Perfusion in the 21st Century
Furthermore, protein retention has been reported when working at high densities with filtration systems. Manufacturers have access to more sophisticated media and more stable cell lines with new selec…
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Microbiological Testing: Time is of the Essence
The results for alternative methods are also often reported in units other than colony forming units (CFUs), which is the typical format for culture-based assays. The results of these tests, therefore…