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: October 28th 2024 | Updated: November 22nd 2024

Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development

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Published: November 6th 2024 | Updated: November 22nd 2024

Automate Aseptic Filling: Closing the System at Full Modularity

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

Untethered Data: Unifying and Contextualizing Drug Discovery Data

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Published: November 8th 2024 | Updated: November 22nd 2024

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification

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