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.
In January 2020, the FDA issued 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.
Read this article in BioPharm International’s Regulatory Sourcebook October 2020 eBook.
BioPharm International
eBook: Regulatory Sourcebook, October 2020
October 2020
Pages: 12–17
When referring to this article, please cite it as P. Wunderli et al.,“Viral Vector API Characterization of Product-Related Impurities," BioPharm International Regulatory Sourcebook eBook (October 2020).
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
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