| Literature DB >> 35135309 |
Rafiq Islam1, Jennifer Vance2, Martin Poirier3, Jennifer Zimmer4, Ardeshir Khadang5, Dave Williams6, Jennifer Zemo6, Todd Lester6, Marianne Fjording6, Amanda Hays6, Nicola Hughes7, Fabio Garofolo8, Curtis Sheldon9, Rudolf Guilbaud10, Christina Satterwhite11, Kelly Colletti11, Elizabeth Groeber12, Heidi Renfrew13, Mathilde Yu14, Jenny Lin15, Xinping Fang16, Mark Wissel17, Thomas Beadnell17, John Lin18, Santosh Shah18, Wei Garofolo19, Natasha Savoie19, Roger Hayes20, John Pirro21, Cheikh Kane21, Marsha Luna21, Allan Xu22, Stephanie Cape23, Mark O'Dell24, Robert Wheller25, Hanna Ritzen26, Esme Farley27, Lisa Kierstead28, William Mylott29, Edward Tabler29, Moucun Yuan29, Shane Karnik30, Troy Voelker31, Ira DuBey1, Clark Williard32, Kelly Dong33, Jing Shi34, Jim Yamashita34.
Abstract
Gene therapy, cell therapy and vaccine research have led to an increased need to perform cellular immunity testing in a regulated environment to ensure the safety and efficacy of these treatments. The most common method for the measurement of cellular immunity has been Enzyme-Linked Immunospot assays. However, there is a lack of regulatory guidance available discussing the recommendations for developing and validating these types of assays. Hence, the Global CRO Council has issued this white paper to provide a consensus on the different validation parameters required to support Enzyme-Linked Immunospot assays and a harmonized and consistent approach to Enzyme-Linked Immunospot validation among contract research organizations.Entities:
Keywords: ELISpot; Enzyme-Linked Immunospot; GCC; cell therapy; cellular immunity; gene therapy; global CRO council in bioanalysis; regulated bioanalysis; vaccine; validation
Mesh：
Year: 2022 PMID： 35135309 DOI： 10.4155/bio-2022-0010
Source DB: PubMed Journal: Bioanalysis ISSN： 1757-6180 Impact factor: 2.681