Advertisement

Setting Up a Successful Radiopharmaceutical Production Facility

  • Ashley MishoeEmail author
  • Phillip DeNoble
Chapter

Abstract

As more radiopharmaceuticals garner regulatory approval and are subsequently reimbursed, more facilities for the production of radiopharmaceuticals will be needed. Setting up a successful radiopharmaceutical production facility can be a daunting task, but careful consideration during the planning stages can help ensure an efficient operation. In this regard, important questions include whether the facility will focus solely on research agents, if the production of commercial radiopharmaceuticals will take place, and whether agents for targeted radiotherapy will be produced. Properly trained staff and a detailed quality assurance system are also keys to success.

Keywords

Facility Validation Setup Equipment Quality assurance Workflow Training 

References

  1. 1.
    National Archives and Records Administration. Office of the Federal Register. Electronic Code of Federal Regulations. Current good manufacturing practice for positron emission tomography drugs. Sect. Part 212. https://catalog.data.gov/dataset/electronic-code-of-federal-regulations.
  2. 2.
    United States Pharmacopeia. Positron emission tomography drugs for compounding, investigational, and research uses. Sect. Chapter 823. USP40-NF35.Google Scholar
  3. 3.
    National Archives and Records Administration. Office of the Federal Register. Electronic Code of Federal Regulations. Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; General. Sect. Part 210. https://catalog.data.gov/dataset/electronic-code-of-federal-regulations.
  4. 4.
    U.S. Food and Drug Administration. FDA guidance for Industry: Process validation: general principles and practices. 2011.Google Scholar
  5. 5.
    National Archives and Records Administration. Office of the Federal Register. Electronic Code of Federal Regulations. Quality system regulation. Sect. Part 820.Google Scholar
  6. 6.
    United States Pharmacopeia. Positron emission tomography drugs-information. Sect. Chapter 1823. USP40–NF35.Google Scholar
  7. 7.
    U.S. Food and Drug Administration. FDA guidance for industry: Sterile drug products produced by aseptic processing – current good manufacturing practice. 2004.Google Scholar
  8. 8.
    U.S. Food and Drug Administration. Q3C – Tables and list guidance for industry. 2017.Google Scholar
  9. 9.
    United States Pharmacopeia. USP Monographs: Fludeoxyglucose F 18 Injection. Sect. USP40-NF35 p. 4520.Google Scholar
  10. 10.
    United States Pharmacopeia. Bacterial endotoxins test. Sect. Chapter 85. USP40-NF35.Google Scholar
  11. 11.
    Milton MJT, Wielgosz RI. Uncertainty in SI-traceable measurements of amount of substance by isotope dilution mass spectrometry. Metrologia. 2000;37(3):199.CrossRefGoogle Scholar
  12. 12.
    Holland JP, Divilov V, Bander NH, Smith-Jones PM, Larson SM, Lewis JS. 89Zr-DFO-J591 for immunoPET of prostate-specific membrane antigen expression in vivo. J Nucl Med. 2010;51(8):1293–300.CrossRefGoogle Scholar
  13. 13.
    Anderson CJ, Schwarz SW, Connett JM, Cutler PD, Guo LW, Germain CJ, et al. Preparation, biodistribution and dosimetry of copper-64-labeled anti-colorectal carcinoma monoclonal antibody fragments 1A3-F(ab′)2. J Nucl Med. 1995;36(5):850–8.PubMedGoogle Scholar
  14. 14.
    Paul-Dauphin S, Karaca F, Morgan TJ, Millan-Agorio M, Herod AA, Kandiyoti R. Probing size exclusion mechanisms of complex hydrocarbon mixtures: the effect of altering eluent compositions. Energy Fuel. 2007;21(6):3484–9.CrossRefGoogle Scholar
  15. 15.
    U.S. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). FDA guidance for industry: Media fills for validation of aseptic preparations for positron emission tomography (pet) drugs. 2012.Google Scholar
  16. 16.
    USP General Chapter ⟨1823⟩ Positron Emission Tomography Drugs – Information. United States Pharmacopeial Convention; 2017.Google Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Department of Radiology and Biomedical ImagingUniversity of California San FranciscoSan FranciscoUSA
  2. 2.Department of RadiologyMemorial Sloan Kettering Cancer CenterNew YorkUSA

Personalised recommendations