TIL Rosenberg Modular Processing Facility (T30 building)

Office Of The Director, Nci

Investigators

Abstract

The NIH / NCI TIL cGMP Modular facility project is a state of the art 10 module standalone facility to be constructed at the NIH campus and will be used to aseptically isolate and expand Tumor Infiltrating Lymphocytes (TILs) cell culture from the primary tumors of enrolled patients as well as patient individualized cellular immunotherapy products for safe infusion into human subjects in compliance with FDA cGMP requirements. When completed, the facility will provide much needed additional cGMP and Cell processing capabilities and support infrastructure that meets the FDA guidelines to industry. The facility completed all commissioning validations and qualifications by March 2021 is forecasted to come on line for cGMP cellular therapy manufacturing by late Fall to early Winter 2021.