Stephen Gacheru

Articles

Viral Vector API Characterization of Product-Related Impurities

Peter Wunderli;Jun Lu;Jie Ding;Mercedes Ames;Marc Wolman;Jared Finger;Stephen Gacheru

October 15th 2020

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.

Latest Updated Articles

Published: October 11th 2024 | Updated: October 18th 2024

Buy, Sell, Hold: Cell and Gene Therapy - Part 1

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Published: September 10th 2024 | Updated: September 18th 2024

CPHI Milan Announces 2024 CPHI Pharma Award Finalists

Published: February 23rd 2024 | Updated: December 22nd 2024

Europa Perspectives: Helping to Navigate the Regulatory System

Published: December 13th 2024 | Updated: December 22nd 2024

FDA Creates CDER Center for Real-World Evidence Innovation

Close-up of a microscope lens examining microarray slides, a crucial tool in genomic research and medical diagnostics | Image Credit: © Varunee - Stock.Adobe.com

Published: December 5th 2024 | Updated: December 22nd 2024

Leveraging Advancements in Bioanalytical Testing

Lipid nanoparticle siRNA antiviral delivery system, 3D illustration | Image Credit: © Dr_Microbe - © Dr_Microbe - stock.adobe.com

Published: December 7th 2024 | Updated: December 22nd 2024

Exploring Opportunities for LNP Delivery in mRNA

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