White Paper: Recommendations on ELISpot Assay Validation by the GCC
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.
Assay development, validation & testing for an mRNA-1273 COVID-19 Vaccine Clinical Trial
Several new immunotherapy technologies, such as cancer vaccines, adoptive cell (CAR T-cell), and checkpoint inhibitor therapies, have emerged as promising approaches to treating cancer patients. Oncolytic virus therapies in particular, combine selective tumor cell killing and induction of anti-cancer immune reactions. Among the most significant safety and efficacy concerns in development of this new class of drugs are neutralization and clearance of virus particles. Check out this case study to learn about methods used to help characterize the biodistribution and transmissibility of an oncolytic virus candidate in a clinical trial.