20.500.12556/DiRROS-21910 Analysis of the measurements used as potency tests for the 31 US FDA-approved cell therapy products Cell therapy product (CTP) developers face the significant challenge of developing appropriate potency tests for their CTPs. A review of the known potency tests used for the 31 United States Food and Drug Administration-approved CTPs (US FDA) can guide developers in designing effective potency tests for future CTPs. Data on these tests were primarily collected from publicly available regulatory documentation on the US FDA website (90%) as well as other sources (literature, company communications, etc.). Based on these data, an estimated 104 total potency tests have been used for the 31 CTPs. Of these, 33 are redacted (32%), leaving 71 non-redacted potency tests. On average, each CTP has 3.4 potency tests (standard deviation 2.0). The 71 non-redacted potency tests were categorized into 5 bins: “Viability and count” (37 tests, 52%), “Expression” (19 tests, 27%), “Bioassays” (7 tests, 7%), “Genetic modification” (6 tests, 9%) and “Histology” (2 tests, 3%). Measurements of gene or protein expression were used by 20 of the 31 CTPs (65%), and 19 CTPs (61%) used measurements of cell viability or cell count as a potency test. “Viability and count” and “Expression” are the two tests that have most often been used together for the same product, occurring for 16 CTPs (52%). It is unclear if bioassays are commonly used as potency tests since only 7 of 31 CTPs (23%) reported bioassays as potency tests. However, due to redactions, as many 24 (77%) CTPs could potentially have a bioassay as a potency test. Additionally, 26 of the 31 CTPs (84%) cite physicochemical assays (non-bioassays) as a potency test. This analysis of potency tests for approved CTPs provides valuable insights for developing potency tests for new CTPs. cell therapy product potency potency test regenerative medicine celična terapija testi učinkovitosti odobrene terapije test moči true false true Angleški jezik Slovenski jezik Neznano 2025-04-10 12:50:16 2025-04-10 12:50:16 2025-10-24 03:50:09 0000-00-00 00:00:00 2025 0 0 Soavtorji: Erich H. Bozenhardt, Christina M. Celluzzi, David Dobnik, Melanie L. Grant, Uma Lakshmipathy, Thiana Nebel, Linda Peltier, Anthony Ratcliffe, James L. Sherley, Glyn N. Stacey, Rouzbeh R. Taghizadeh, Eddie H. P. Tan & Sandrine Vessillier; Nasl. z nasl. zaslona; Opis vira z dne 20. 3. 2025; str. 1-21 Vol. 23, [article no.] 259 2025 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 2025-03-04 576:602 1479-5876 10.1186/s12967-025-06253-4 229687043 https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-025-06253-4 1 97bc1c07-15f9-11f0-963a-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=31601 RAZ_Simon_Jr._Carl_G._2025.pdf RAZ_Simon_Jr._Carl_G._2025.pdf 1 553136ADCBBC0B0D9EDB1D60313FCE14 48ea9ef9e09a1f3fda4c381fe5acf2263d1b6419b2cb8aaa63d0f04515b2fec9 baae2fab-15f9-11f0-963a-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=31602 Supplementary_information.zip Supplementary_information.zip Dopolnilne informacije 1 8464185A0A5FE0A578F269ACFEE5B378 21a47ab05ea1593d1341712cbff0930701f6e68e06071ef3ff653dbdc3894f18 c9ad8c24-1909-11f0-963a-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=31658 Nacionalni inštitut za biologijo 0 0 0