Human embryonic stem cells (hESCs) may serve as a renewable, unlimited source of cells for transplantation therapy. Animal-component-free clinical-grade human embryonic stem cell (hESC) lines are especially desirable in that they can be used in a therapeutic environment without fear of immunorejection or contamination by animal viruses or prions inherent in non-animal-free hESC sources. Safety must be the primary concern when deriving new stem cell lines, Clinical-grade human embryonic stem cell derivation requires strict adherence to ethical requirements for embryo procurement as well as conformance to regulations controlling clinical-grade cell and tissue product development, manufacturing, and testing. A robust quality-assurance program with approved specifications, standard operating procedures (SOPs), analytical methods, and manufacturing instructions must be in place. As such, these collective activities demonstrate to the FDA and other regulatory bodies that the biosafety, manufacturing, and testing profiles of the cells will meet their requirements for clinical applications.
|School:||California State University, Dominguez Hills|
|School Location:||United States -- California|
|Source:||MAI 48/05M, Masters Abstracts International|
|Subjects:||Molecular biology, Statistics, Pharmacy sciences|
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