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COVID-19 Update
Analytics
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Analytical Methods
BioBusiness
Cell Culture/Fermentation
Continuous Processing
Drug Delivery
Fill/Finish
Formulation
Process Chromatography
Process Control/PAT
Process Development
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Separation and Purification
Single-Use Systems
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Articles

Viral Vector API Characterization of Product-Related Impurities

FDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.