TY - JOUR
T1 - Robotic preparation of Sodium Acetate C 11 Injection for use in clinical PET
AU - Moerlein, Stephen M.
AU - Gaehle, Gregory G.
AU - Welch, Michael J.
N1 - Funding Information:
This work was supported by NIH grant HL13851. We thank W. Margenau for equipment construction and radioisotope production, D. Ficke for radioisotope production, and K. Lechner for assistance with quality control procedures.
PY - 2002
Y1 - 2002
N2 - Sodium Acetate C 11 Injection is a radiopharmaceutical commonly used for clinical studies with positron emission tomography (PET). We have designed a fully-automated robotic system for the compounding of this 20-minute half-lived tracer in the clinical setting. The system is comprised of five modular workstations that are configured in a flexible manner to accommodate all of the steps in the production of the labeled drug. The Trapping Station isolates cyclotron-produced [11C]CO2 gas from the target and directs carbonation of methylmagnesium Grignard in diethyl ether. The Heating Station hydrolyzes the intermediate, and removes ether and unreacted [11C]CO2 from the mixture. The Extraction Station removes ionic and organic contaminants from the drug using solid-phase extraction (AG 11A8 and C18 resin). The Filtration Station sterilizes the radiopharmaceutical, and tests membrane patency post filtration. The Assay Station measures the weight and radioactivity content of the Final Product Container, facilitating calculation of activity concentration in a remote manner. Rapid quality control methodology has also been developed that is suitable for pre-release analysis of the drug product. For a 7.5 min irradiation with a 40 μA proton beam, 223-300 mCi of Acetate C 11 Injection with purity meeting USP standards is produced within 23 min. This robotic system is a reliable method for producing Sodium Acetate C 11 Injection, USP in the clinical setting with minimal personnel exposure. Moreover, its design flexibility permits synthesis of additional 11C- or 18F-labeled PET tracers within the same shielded hot cell.
AB - Sodium Acetate C 11 Injection is a radiopharmaceutical commonly used for clinical studies with positron emission tomography (PET). We have designed a fully-automated robotic system for the compounding of this 20-minute half-lived tracer in the clinical setting. The system is comprised of five modular workstations that are configured in a flexible manner to accommodate all of the steps in the production of the labeled drug. The Trapping Station isolates cyclotron-produced [11C]CO2 gas from the target and directs carbonation of methylmagnesium Grignard in diethyl ether. The Heating Station hydrolyzes the intermediate, and removes ether and unreacted [11C]CO2 from the mixture. The Extraction Station removes ionic and organic contaminants from the drug using solid-phase extraction (AG 11A8 and C18 resin). The Filtration Station sterilizes the radiopharmaceutical, and tests membrane patency post filtration. The Assay Station measures the weight and radioactivity content of the Final Product Container, facilitating calculation of activity concentration in a remote manner. Rapid quality control methodology has also been developed that is suitable for pre-release analysis of the drug product. For a 7.5 min irradiation with a 40 μA proton beam, 223-300 mCi of Acetate C 11 Injection with purity meeting USP standards is produced within 23 min. This robotic system is a reliable method for producing Sodium Acetate C 11 Injection, USP in the clinical setting with minimal personnel exposure. Moreover, its design flexibility permits synthesis of additional 11C- or 18F-labeled PET tracers within the same shielded hot cell.
KW - PET
KW - Radiopharmaceuticals
KW - Robotics
KW - Sodium Acetate C 11 Injection
KW - USP
KW - [1-C]Acetate
UR - http://www.scopus.com/inward/record.url?scp=0035999178&partnerID=8YFLogxK
U2 - 10.1016/S0969-8051(02)00307-4
DO - 10.1016/S0969-8051(02)00307-4
M3 - Article
C2 - 12088733
AN - SCOPUS:0035999178
SN - 0969-8051
VL - 29
SP - 613
EP - 621
JO - Nuclear Medicine and Biology
JF - Nuclear Medicine and Biology
IS - 5
ER -