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Category: Cell Therapy

Safety and Efficacy Testing of Cell Therapies

An Overview of Cell Therapy: As we continue our blog series on cell and gene therapy, we will now dive into cell therapy programs. If…

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Bioanalytical Support for Gene Therapy Programs

An Introduction to Gene Therapy: As early as the 1970’s, the term “gene therapy” was used for the treatment of genetic disorders at the DNA…

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CLIA Requirements for Gene and Cell Therapy Programs

It's a common misconception that all aspects of cell & gene therapy research and development are excluded from CLIA oversight. We take a closer look…

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The FDA’s Response to an Increase in the Development of Gene and Cell Therapies: What It Means for Sponsors

...material, gene therapy uses DNA to manipulate a patient’s cells to compensate for abnormal genes or to make a beneficial protein, and cell therapy

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