36C25518Q9572-001.docx

?.## STATEMENT OF WORK

Harry S. Truman Memorial Hospital (Columbia, MO)

OBJECTIVE:

This purchase is one of the required components of the Truman VA Clinical Research Radiopharmacy. This instrument will enable automated production of radiopharmaceuticals in the Truman VA Clinical Research Radiopharmacy.

TITLE:

Modular Lab Automated Cassette Radiosynthesis System for Radiolabeling Peptides/Small Molecules

Purpose:

Purchase of a modular lab cassette system for automated radiosynthesis of peptides and small molecules for use in the Truman VA Clinical Research Radiopharmacy.

TASKS AND ASSOCIATED DELIVERABLES:

· The system must include all components to be a stand-alone system (system controller preloaded with automated radiosynthesis software, electrical cabinet, and automated radiosynthesis hardware).

· The system must be fully automated to reduce radiation exposure to the technical staff.

· The system must be compatible with and permit direct translation of synthetic methods/procedures developed using an existing Eckert & Ziegler Pharmtracer radiosynthesis system.

· The unit must enable radiosynthesis of peptides and small molecules to current Good Manufacturing Practices (cGMP) specifications (for example Ga-68-PSMA) using sterile single-use disposable cassettes to maintain product sterility and eliminate radioactive contamination of the modular lab system hardware and related components.

· The system must include software and hardware capable of radiolabeling peptides/small molecules with multiple radioisotopes (68Ga, 177Lu, 111In, 90Y, etc.) using a sterile single-use cassette based system to avoid contamination of the system.

· The system must be capable of routinely completing multiple radiosynthesis production runs per day.

· The system must be capable of direct connection and elution of a commercial 68Ge/68Ga generator.

· The system should be designed to permit direct connection to a HPLC system.

· The system must include the necessary reagents, supplies, and cassettes for demonstrating the capability of the system for eluting a commercial Ga-68 generator and synthesizing a Ga-68-radiolabeled peptide.

· Training will be conducted on-site by the vendor upon completion of installation.

· Training must include hardware components (set-up/operation and recommended routine maintenance), software applications (radiosynthesis protocol development for specific products), and automated radiosynthesis report generation.

· User’s manuals (electronic or print copies) must be provided for each component of the system to explain routine maintenance and trouble-shooting guides (hardware and software components).