Gene Therapy Analytical Development Vital tools in gene therapy product manufacturing

Gene therapy product manufacturing involves three types of analytical assays: characterization assays, in-process assays, and release assays. It is important to note that the regulatory oversight by the United States Food & Drug Administration (FDA) differs for these types of assays.
Characterization assays
Characterization assays are used to analyze the gene therapy product and understand its physical, chemical, and biological properties. They help in determining the product's structure, composition, and functionality. While the FDA does not directly regulate characterization assays, it expects them to be conducted based on sound scientific principles to ensure the safety and effectiveness of the product.

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