Strategies for Achieving Measurement Assurance for Cell Therapy Products
Carl G. Simon Jr., Anne L. Plant, Sumona Sarkar, John T. Elliott, Sheng Lin-Gibson
Cell therapy products (CTPs) need quantitative, validated, and robust assays to support informed decision making during their development, manufacturing, and regulation. These products, the materials involved in their production and the methods for characterizing them are complex, making it challenging to validate and standardize measurements for this field. A workshop held at the National Institute of Standards and Technology examined measurement assurance strategies for cell therapy products.