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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.
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When referring to this article, please cite it as P. Wunderli et al., “Viral Vector API Characterization of Product-Related Impurities," Pharmaceutical Technology Regulatory Sourcebook eBook (October 2020).