Search results for " industry" in Articles / App Notes
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
The problem of copying biologics
Biologic drugs have revolutionized the pharmaceutical industry by attacking disease using the mechanisms of the cell and immune system. These therapies are fragile…
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Single-use Bioreactors Have Reached the Big Time
Norris agrees that in addition to longer life-times for new processes, the industry is actively seeking single-use sensors with better accuracy and precision. She does note, however, that the state of…
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Reconciling Sensor Communication Gaps
To manage these complexities, Emerson is betting on augmented reality—a technology under evaluation in the oil and gas industry—which the company believes could help the design and validation of bioma…
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Single-Use Extractables and Leachables: Cytiva's Alignment with the BPOG Protocol
Copious amounts of data have been generated by the industry, but most of it is held under confidentiality. Trade organizations, such as the Bio-Process Systems Alliance (BPSA) and suppliers have deriv…
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Establishing Acceptance Criteria for Analytical Methods
FDA, Analytical Procedures and Methods Validation for Drugs and Biologics, Guidance for Industry (CDER, July 2015).
7. T. Little, Accuracy to Precision (ATP) Profiler.
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Real Time Continuous Microbiological Monitoring
Conclusion
The pharmaceutical industry is moving toward continuous manufacturing and control to ensure full understanding of the aseptic manufacturing process and product quality. Envi…
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Perfusion in the 21st Century
Within the past decade, however, changes in the biopharmaceutical industry and advances in perfusion technology have increased its rate of adoption. Many drugs have or will soon come off patent, incre…
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A Q&A with Eric Langer: CMOs Embrace New Technology
What was the most surprising trend revealed in the 13th Annual Report and Survey of BioManufacturing? Why?
The bioprocessing industry, as a regulated environment, does not adopt novel approaches…
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Downstream Processing Continues to Worry CMOs
Perhaps as a result, the industry’s demand for new chromatography products appears to have slightly abated. This year, chromatography products ranked 6 out of 23 new product development areas of inter…
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Reporting Quality Metrics to FDA
Since the publication of FDA’s draft guidance, Request for Quality Metrics, Guidance for Industry (1), in July 2015, we have been debating how to best capture and report quality metrics in our organiz…