Transforming an Academic Radiochemistry Facility for Positron Emission Tomography Drug cGMP Compliance Academic Article uri icon

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  • 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).


  • Zhu, Shaojun
  • Mosessian, Sherly
  • Kroeger, Kurt
  • Sadeghi Hosseini, Seyed Saman
  • Slavik, Roger
  • Kinloch, Simon
  • Moore, Melissa
  • Allen-Auerbach, Martin
  • Czernin, Johannes
  • Phelps, Michael

publication date

  • April 2020