Search results for "biopharm"
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Transformative Medicines Challenge FDA and Manufacturers
Biopharma researchers also are achieving success in developing oligonucleotide therapies, including antisense drugs and short interfering RNA treatments (siRNAs) that can modulate immune pathways. Saf…
Article
QbD Improves Cell-Culture Process Control
Mammalian cells are most frequently used as the hosts for manufacturing complex biopharmaceuticals, and cultivation of these host cells is a key factor in the production of biotherapeutics. The cultiv…
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Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…
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Reducing Cross-Contamination Risks in Process Chromatography
Elimination of cleaning and cleaning validation activities also leads to smaller and simpler (open ballroom) facilities for biopharmaceutical manufacturing.
Market risks can be minimized …
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Evaluating Surface Cleanliness Using a Risk-Based Approach
…ncentrations, light intensity, viewing angles, inspectors, and distances have been used by multiple biopharmaceutical companies. This approach has helped correlate rinse sample quality or visual insp…
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Platform Technologies Improve Protein Expression
Challener
Speed to market is essential in the biopharmaceutical industry today. Manufacturers are seeking mechanisms for increasing efficiencies and reducing costs without compromising the…
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Patenting Prospects for Cell-Based Therapies
Cell-based therapies are moving medical treatments forward, but intellectual property uncertainties may delay progress.
By Kevin Noonan
Treatment using cell-based therapies is a rapidl…
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Bioburden Control in the Biopharmaceutical Industry
By Mostafa Eissa
The biopharmaceutical industry has witnessed tremendous breakthroughs during the past few years. However, this advancement is accompanied by an increasing populatio…
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Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
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Process Chromatography: Continuous Optimization
Monoclonal antibodies (mAbs), which today account for approximately 50% of the total revenues of all biopharmaceuticals according to David Westman, global product marketing manager for Cytiva, are typ…