ASTM International’s medical and surgical materials and devices committee (F04) will aid procedures for multiplying tissue cell cultivation in laboratory situations. Both normal and diseased tissue cells are cultured in laboratories for research, drug discoveries, toxicological tests, and producing products for cell therapies and cultured food.

The new standard (F3716) describes methods for measuring and comparing the multiplication properties of cells in analyses and processes that are commonly practiced in a wide range of areas. These include academic cell research, pharmaceutical and biopharmaceutical drug evaluations, cell and tissue biomanufacturing, regenerative medicine, toxicology, and the emerging cultured food industry.

“These industries need a reliable test method for assessing and comparing the quality of cell expansion processes. This new standard provides an important basis for the kinds of quality certifications and regulations that ensure the development of more effective medicines and cell-based therapies for patients,” says ASTM member James Sherley, president and CEO of Asymmetrex, LLC.

Today, many methods used for measuring cell multiplication properties are unreliable and highly variable, with results that could not be validly compared from one test to another. This significantly limits the reproducibility needed for high-quality science and therapeutic development.
“The new standard fills a long-standing need, ensuring reliable procedures with results that can be directly compared among different testers, testing sites, and cell analysis tools,” says Sherley.

F3716 will be a foundational test method for developing an upcoming standard for differential stem cell counting. All interested parties, particularly those with tissue stem cell biology and biotechnology experience, are encouraged to join the committee in the development of this and other related standards.

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