Many assays have integrated, built-in, or internal controls to demonstrate their operability at specific procedural steps. What role do these built-in controls play in quality control to assure ...
Partnership addresses biopharmaceutical industry's urgent need for improved in-process and QC testing tools for these rapidly evolving application fields BOULDER, CO - (NewMediaWire) - June 5, 2024 - ...
New York, July 10, 2023 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cell and Gene Therapy Manufacturing QC Market - A Global and Regional Analysis : Focus on Therapy Type ...
Biopharma quality control is being revolutionized by advanced analytics and digital transformation through a synergy that boosts quality and scalability. *Full transcript available below. Digital ...
The Food & Drug Administration's recent approval of process analytical technology (PAT) for use in the pharmaceutical industry is being hailed by drug manufacturers because it encourages process ...
More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes. Complex ...
Twelve gene therapies have been approved by the FDA to date to treat a variety of diseases, including the first ever gene edited therapeutic. The CMC package required to effectively demonstrate safety ...
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