Scientific Expertise

February 23, 2022

Gene therapy, cell therapy, and vaccine research have raised the need for regulated cellular immunity testing. Enzyme-Linked Immunospot (ELISPOT) assays are commonly used, but regulatory guidance on their validation is lacking. The Global CRO Council has issued a white paper to outline validation parameters and promote consistent ELISPOT validation across organizations.

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.

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