Stephen Gacheru

Final Guidance for Industry: Chemistry Manufacturing and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

 and  other guidance documents for human gene therapies, which set expectations for manufacturing and demonstration of quality (1). These products are applied to deliver genetic material (transgenes) or modified cells that have been designed to alleviate or even eliminate a broad range of diseases that are rooted in the genetics of individuals or populations of patients.

Pharmaceutical Technology's Regulatory Sourcebook


eBook: Regulatory Sourcebook
October 2020
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Viral Vector API Characterization of Product-Related Impurities

Pharmaceutical Technology Regulatory Sourcebook

Articles

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.