Modernization of the shielded laminar flow environment for molecular probe manufacture

The Department of Health and Human Services National Institutes of Health Office of the Director awarded Vanderbilt University Medical Center $210,120 on September 1, 2026, to purchase and install a shielded laminar flow hood for the manufacture of investigational radiopharmaceuticals and molecular imaging agents under the Research Infrastructure Programs (CFDA 93.351).

The equipment—a von Gahlen shielded laminar flow hood with included dose calibrator and UV sterilization system—will replace a 15-year-old biological safety cabinet at the Vanderbilt University Institute of Imaging Science's Radiochemistry Core (RCC) facility. The RCC operates an ISO5 environment critical for aseptic operations including final vial assembly, quality control, and dose drawing in clinical research manufacturing. The modernized infrastructure will enable continued compliance with cGMP and FDA regulatory requirements and support the core's role in providing research molecular imaging agents for use on three human PET/CT imaging systems, two pre-clinical PET imaging systems, and other end uses. Researchers at Vanderbilt University, Vanderbilt University Medical Center, the nearby VA, and Meharry Medical College—an HBCU historically black academic health science center—will have access to the facility. The period of performance runs through August 31, 2027, with work performed in Forest Hills, Tennessee.

Abstract

This application requests funding to support the purchase of a new shielded laminar flow hood for the manufacture of investigational radiopharmaceuticals and molecular imaging agents. The system will be installed at the vanderbilt university institute of imaging science's radiochemistry core (RCC) facility; a core that allows access to research molecular imaging agents for use on three human pet/CT imaging systems, two pre-clinical pet imaging systems and a variety of other end uses. The core also offers expertise in allowing investigators to develop novel imaging agents for routine production. The system will be utilized by researchers at vanderbilt university and vanderbilt university medical center, as well as being available for use by investigators at the nearby VA and nashville's meharry medical college, an hbcu that is one of the nation's oldest and largest historically black academic health science centers. Currently, the RCC operates a 15-year-old germfree shielded biological safety cabinet as its primary infrastructure for operations requiring an ISO5 environment. As an ISO5 environment is required for all aseptic operations such as final vial assembly, quality control, and dose drawing IT is one of the most critical pieces of equipment in the facility; as IT is needed for all manufacturing operations for clinical research. As the current equipment has aged and compliance requirements have increased, a modernization of the environmentally control infrastructure is needed. This equipment will allow the radiochemistry core to continue to meet the needs of our NIH-funded user base and will enable continued cgmp/FDA regulatory compliance in the increasingly challenging regulatory environment. The proposed equipment is a VON gahlen shielded laminar flow hood, with an included dose calibrator, and UV sterilization system. IT has been specifically selected to allow for rapid installation in the core facility. The proposed equipment will greatly enhance the existing NIH-supported clinical research projects that utilize radiopharmaceuticals and other molecular imaging agents.