GE FASTlab

GE FASTlab
Name	GE FASTlab
Manufacturer	General Electric
Type	Automated radiopharmaceutical synthesis module
Country	United States

GE FASTlab

GE FASTlab is an automated synthesis platform used for production of radiopharmaceuticals, particularly positron emission tomography tracers. It integrates modules for radiosynthesis, purification, and dispensing, and is deployed in academic centers, nuclear medicine departments, and commercial radiopharmacies. The system interfaces with cyclotrons, hot cells, and liquid handling robotics and is used in workflows connecting imaging centers and regulatory authorities.

Overview

The platform is designed to connect with cyclotron-produced isotopes from suppliers such as Advanced Cyclotron Systems, IBA (company), Siemens Healthcare facilities and to serve clinical sites like Mayo Clinic, Massachusetts General Hospital, Johns Hopkins Hospital. It competes with synthesis modules from GE Healthcare, Eckert & Ziegler, Sofie Biosciences, Trasis, and ABX Advanced Biochemical Compounds used at institutions including UCLA, Harvard Medical School, University of Pennsylvania and contractors working for Nuclear Regulatory Commission-regulated operations. Deployment considerations often involve coordination with accreditation bodies such as American College of Radiology, Joint Commission and standards from United States Pharmacopeia chapters applied at sites like Memorial Sloan Kettering Cancer Center.

Technology and Design

The hardware integrates microfluidic manifolds, cassette-based disposable fluid paths, and synthesis control software developed by teams within General Electric Company and interoperates with laboratory equipment from Thermo Fisher Scientific, PerkinElmer, Agilent Technologies. Control systems support interfaces to laboratory information management systems used at Cleveland Clinic, Stanford University Medical Center, MD Anderson Cancer Center and implement security practices aligned with standards from National Institute of Standards and Technology and International Organization for Standardization. Design choices reflect input from radiochemists associated with groups at Brookhaven National Laboratory, Argonne National Laboratory, Lawrence Berkeley National Laboratory and imaging consortia such as SNMMI and EANM.

Applications and Clinical Use

FASTlab-compatible syntheses include tracers for oncology, neurology, and cardiology. Typical radiopharmaceuticals produced connect to clinical uses at cancer centers like Dana-Farber Cancer Institute and research studies led by investigators from Columbia University and Yale School of Medicine. Common PET tracers produced on cassette systems are used alongside PET/CT scanners from Siemens Healthineers, Canon Medical Systems, Philips Healthcare in clinical trials sponsored by entities such as National Institutes of Health, European Commission research programs, and industry partners like Roche and Novartis. The platform supports production of molecules relevant to trials run by cooperative groups such as Radiological Society of North America-affiliated investigators and multicenter networks led by NCI-funded consortia.

Manufacturing and Automation

Manufacturing workflows employ single-use cassettes sourced from suppliers with quality systems aligned to Good Manufacturing Practice guidelines and contract manufacturing organizations like Catalent or Recipharm when scaling. Automation strategies incorporate robotics from firms such as ABB and KUKA for cassette handling within shielded hot cells produced by vendors like Nuklear Medical and Melinex/MBraun. Production sites coordinate logistics with carriers experienced in radioactive transport and regulatory compliance offices at institutions including FDA-registered facilities and national agencies such as Health Canada, European Medicines Agency when distributing tracers for multicenter trials involving sites like Imperial College London and Karolinska Institutet.

Regulatory and Quality Considerations

Quality systems address sterility, radionuclidic purity and chemical purity consistent with monographs from United States Pharmacopeia and oversight by regulators such as Food and Drug Administration, European Medicines Agency and national competent authorities in countries hosting centers like Peter MacCallum Cancer Centre. Validation protocols involve collaboration with clinical research organizations, institutional review boards at University of Chicago and certification by bodies such as College of American Pathologists when applicable. Safety procedures reflect guidelines from International Atomic Energy Agency and incident reporting frameworks used by hospitals like Beth Israel Deaconess Medical Center.

Performance and Comparative Systems

Performance metrics often cited include radiochemical yield, molar activity, synthesis time and reproducibility benchmarked against modules from TRASIS, Iba Modular-Lab, Sofie Biosciences ELIXYS, Eckert & Ziegler Modular-Lab and bespoke systems developed at University of Leuven and Massachusetts Institute of Technology. Comparative studies in journals by investigators from Stanford University, University College London and Karolinska Institutet evaluate throughput for tracers such as fluorodeoxyglucose analogs used in protocols at Memorial Sloan Kettering Cancer Center, Royal Marsden Hospital, and tracer candidates advanced by biotech firms like Blue Earth Diagnostics and Point Biopharma. Operational performance is also assessed in routine service settings at diagnostic networks like HCA Healthcare and public health systems including NHS England.

Category:Radiopharmaceutical instrumentation