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Updated: Jan 23, 2026

Automation of a Positron-emission Tomography PET Radiotracer Synthesis Protocol for Clinical Production
Published on: October 26, 2018
Transforming an Academic Radiochemistry Facility for Positron Emission Tomography Drug cGMP Compliance
Shaojun Zhu1, Sherly Mosessian2, Kurt Kroeger3
1Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, UCLA, Los Angeles, CA, 90095, USA. SZhu@mednet.ucla.edu.
Abstract:
In light of the United States Food and Drug Administration (FDA) requirement of 21 CFR 212 current Good Manufacturing Practice (cGMP) for FDA-approved position emission tomography (PET) drugs, the University of California Los Angeles (UCLA) Biomedical Cyclotron (BMC) transformed from a pre-cGMP era academic cyclotron and radiochemistry facility to a current cGMP-compliant PET drug manufacturer. In this article, we share the financial and regulatory compliance aspects of the "transformation" required to develop a sustainable quality system to support the production of two PET drugs under Abbreviated New Drug Applications (ANDAs).
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