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 process Tumor Infiltrating Lymphocytes (TILs) cell culture for safe injection into human subjects in compliance with FDA cGMP requirements. The facility will provide over 6000 SF of cGMP, NCN, ISO 7, ISO 8 rooms, and infrastructure support that will meet the FDA Guidance to Industry, Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (Draft Guidance 2009) and the FDA Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing (Sept. 2004). The facility is forecasted to come on line by mid-summer 2020.
