As cell and gene therapies have progressed in the last decade, the quality requirements for cell samples have increased because they are involved directly with patient treatment. This necessitates the replacement of traditional cell counting methods with modern, high quality alternatives.
Cell counting is crucial for products reviewed by multiple FDA centers, as well as all phases of cell and gene therapy and regenerative medicine drug evaluation. Modernization of cell counting measurements is critical to support the development and manufacturing of these advanced biological products.
This Ebook provides best practices for selecting, comparing, and evaluating cell counting methods as detailed in several articles created in collaboration by the US Food and Drug Administration (FDA) in collaboration with the US
National Institute of Standards and Technology (NIST) and the International Organization for Standardization (ISO).