Skip to main content
SpringerLink
Log in

Production of clinical radiopharmaceuticals: general pharmaceutical and radioanalytical aspects

  • Published:
Journal of Radioanalytical and Nuclear Chemistry Aims and scope Submit manuscript

Abstract

Due to successes in the development on new and powerful radiopharmaceuticals, in particular of tracers for positron emission tomography, the production of a continuously expanding spectrum of radiopharmaceuticals has become more important, even for small nuclear medicine facilities. This short review summarizes and briefly describes typically established radioanalytical routines in the quality control of radiopharmaceuticals as well as the corresponding fundamental legal documents and guidelines.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Weissleder R, Pittet MJ (2008) Imaging in the era of molecular oncology. Nature 452(7187):580–589

    Article  CAS  Google Scholar 

  2. Wester HJ (2007) Nuclear imaging probes: from bench to bedside. Clin Cancer Res 13(12):3470–3481

    Article  CAS  Google Scholar 

  3. Jacobson O, Kiesewetter DO, Chen X (2015) Fluorine-18 radiochemistry, labeling strategies and synthetic routes. Bioconjug Chem 26(1):1–18

    Article  CAS  Google Scholar 

  4. Braghirolli AM, Waissmann W, da Silva JB, dos Santos GR (2014) Production of Iodine-124 and its applications in nuclear medicine. Appl Radiat Isot 90:138–148

    Article  CAS  Google Scholar 

  5. Velikyan I (2015) 68Ga-based radiopharmaceuticals: production and application relationship. Molecules 20(7):12913–12943

    Article  CAS  Google Scholar 

  6. Kasbollah A, Eu P, Cowell S, Deb P (2013) Review on production of 89Zr in a medical cyclotron for PET radiopharmaceuticals. J Nucl Med Technol 41(1):35–41

    Article  Google Scholar 

  7. Park JA, Kim JY (2013) Recent advances in radiopharmaceutical application of matched-pair radiometals. Curr Top Med Chem 13(4):458–469

    Article  CAS  Google Scholar 

  8. Schottelius M, Wirtz M, Eiber M, Maurer T, Wester HJ (2015) [111In]PSMA-I&T: expanding the spectrum of PSMA-I&T applications towards SPECT and radioguided surgery. EJNMMI Res 5(1):68

    Article  Google Scholar 

  9. Srivastava SC (2012) Paving the way to personalized medicine: production of some promising theragnostic radionuclides at Brookhaven National Laboratory. Semin Nucl Med 42(3):151–163. doi:10.1053/j.semnuclmed.2011.12.004

    Article  Google Scholar 

  10. Greenberg JH, Reivich M, Alavi A, Hand P, Rosenquist A, Rintelmann W, Stein A, Tusa R, Dann R, Christman D, Fowler J, MacGregor B, Wolf A (1981) Metabolic mapping of functional activity in human subjects with the [18F]fluorodeoxyglucose technique. Science 212:678–680

    Article  CAS  Google Scholar 

  11. Reivich M, Kuhl D, Wolf A, Greenberg J, Phelps M, Ido T, Casella V, Fowler J, Hoffman E, Alavi A, Som P, Sokoloff L (1979) The [18F]fluorodeoxyglucose method for the measurement of local cerebral glucose utilization in man. Circ Res 44(1):127–137

    Article  CAS  Google Scholar 

  12. Fowler JS, Ido T (2002) Initial and subsequent approach for the synthesis of 18FDG. Semin Nucl Med 32(1):6–12 (Review)

    Article  Google Scholar 

  13. http://apps.webofknowledge.com

  14. Notni J, Steiger K, Hoffmann F, Reich D, Kessler H, Schwaiger M, Wester HJ (2016) Variation of specific activities of Ga-68-aquibeprin and Ga-68-avebetrin enables selective PET-imaging of different expression levels of integrins α5β1 and αvβ3. J Nucl Med 57(10):1618–1624

    Article  Google Scholar 

  15. Velikyan I, Sundin A, Eriksson B, Lundqvist H, Sörensen J, Bergström M, Långström B (2010) In vivo binding of [68Ga]-DOTATOC to somatostatin receptors in neuroendocrine tumours–impact of peptide mass. Nucl Med Biol 37(3):265–275

    Article  CAS  Google Scholar 

  16. Bakker WH, Breeman WA, Kwekkeboom DJ, De Jong LC, Krenning EP (2006) Practical aspects of peptide receptor radionuclide therapy with [177Lu][DOTA0, Tyr3]octreotate. Q J Nucl Med Mol Imaging 50(4):265–271

    CAS  Google Scholar 

  17. de Blois E, Sze Chan H, Naidoo C, Prince D, Krenning EP, Breeman WA (2011) Characteristics of SnO2-based 68Ge/68Ga generator and aspects of radiolabelling DOTA-peptides. Appl Radiat Isot 69(2):308–315

    Article  Google Scholar 

  18. The European Parliament and the Council of the European Union (2001) Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the community code relating to medicinal products for human use. Off J Eur Union 311:1–66

    Google Scholar 

  19. EU Pharmaceutical Information (2003) EudraLex—volume 4 good manufacturing practice (GMP) guidelines. http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm

  20. European Directorate of Quality of Medicines (2011) Compounding of radiopharmaceuticals. Pharmeuropa 23(4):643

    Google Scholar 

  21. European Pharmacopoeia (Ph. Eur.) Vol 8 (2013–2016) European Directorate of Quality of Medicines

  22. US Food and Drug Administration (2011) Federal register. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=212

  23. US Food and Druig Administration (2011) Guidance PET drugs—current good manufacturing practice (CGMP), small entity compliance guide. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM266640.pdf

  24. United States Pharmacopeia (2010)

  25. Decristoforo C, Schwarz SW (2011) Radiopharmacy: regulations and legislations in relation to human applications. Drug Discov Today Technol 8(2–4):e71–e77

    Article  Google Scholar 

Download references

Acknowledgements

Funding was provided by Deutsche Forschungsgemeinschaft (Grant No. SFB824, subproject Z1).

Author information

Authors and Affiliations

  1. Chair for Pharmaceutical Radiochemistry, Technischen Universität München, Walther-Meissner-Strasse 3, 85748, Garching, Germany

    Alexander Schmidt, Margret Schottelius & Hans-Jürgen Wester

  2. Department of Nuclear Medicine, Klinikum r.d.Isar der Technischen Universität München, Ismaninger Strasse 22, 81675, Munchen, Germany

    Michael Herz

Authors
  1. Alexander Schmidt
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Margret Schottelius
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Michael Herz
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Hans-Jürgen Wester
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Hans-Jürgen Wester.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Schmidt, A., Schottelius, M., Herz, M. et al. Production of clinical radiopharmaceuticals: general pharmaceutical and radioanalytical aspects. J Radioanal Nucl Chem 311, 1551–1557 (2017). https://doi.org/10.1007/s10967-016-5125-6

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10967-016-5125-6

Keywords

Search

Navigation