Regulatory requirements for PET radiopharmaceuticals production: Is automation an answer?

Current Medical Imaging Reviews

Volumn 4, Issue 1, 2008, Pages 28-33

  Sims Mourtada, Jennifer ^a,b   Azhdarinia, Ali ^a,b   Yang, David J ^b   Mourtada, Firas ^b  

^a RadioMedix Inc   (United States)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Automation; FDA; Imaging; PET; Radiopharmaceuticals; Radiotracers

Indexed keywords

1 FLUORO 3 (2 NITRO 1 IMIDAZOLYL) 2 PROPANOL F 18; 1,4,7,10 TETRAAZACYCLODODECANE 1,4,7,10 TETRAACETIC ACID GA 68; 1,4,7,10 TETRAAZACYCLODODECANE 1,4,7,10 TETRAACETIC ACID TYROSINE OCTREOTIDE GA 68; 2 FLUORODEOXYMANNOSE F 18; 2 FLUOROETHYLSPIPERONE F 18; 6 FLUORODOPA F 18; CARBON 11; FLUORINE 18; FLUOROACETIC ACID F 18; FLUORODEOXYGLUCOSE F 18; FLUOROSTRADIOL F 18; GALLIUM 68; OLIGONUCLEOTIDE GA 68; RADIOPHARMACEUTICAL AGENT; TRACER; UNCLASSIFIED DRUG;

BATCH PROCESS; COMPUTER PROGRAM; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG PURITY; DRUG QUALITY; DRUG STERILITY; DRUG SYNTHESIS; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HUMAN; ISOTOPE LABELING; LABORATORY AUTOMATION; NONHUMAN; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PROCESS TECHNOLOGY; QUALITY CONTROL; RADIATION PROTECTION; REPRODUCIBILITY; REVIEW; SAFETY;

EID: 39049107152     PISSN: 15734056     EISSN: None     Source Type: Journal    
DOI: 10.2174/157340508783502804     Document Type: Review

References (49)

1. Schillaci O, Simonetti G. Fusion imaging in nuclear medicine - applications of dual-modality systems in oncology. Cancer Biother Radiopharm 2004; 19: 1-10.
2. Paulino AC, Thorstad WL, Fox T. Role of fusion in radiotherapy treatment planning. Semin Nucl Med 2003; 33: 238-243.
3. Srivastava SC. Is there life after technetium: what is the potential for developing new broad-based radionuclides? Semin Nucl Med 1996; 26: 119-131.
4. Gatley SJ, DeGrado TR, Kornguth ML, et al. Radiopharmaceuticals for positron emission tomography. Development of new, innovative tracers for measuring the rates of physiologic and biochemical processes. Acta Radiol Suppl 1990; 374: 7-11.
5. Mason NS, Mathis CA. Positron emission tomography radio-chemistry. Neuroimaging Clin N Am 2003; 13: 671-687.
6. US Pharmacopeia <823>. Radiopharmaceuticals for Positron Emission Tomography-Compounding; 2003.
7. FDA. Food and Drug Administration Modernization Act of 1997. Public Law 1997: 105-115.
8. Som P, Atkins HL, Bandoypadhyay D, et al. A fluorinated glucose analog, 2-fluoro-2-deoxy-D-glucose (F-18): nontoxic tracer for rapid tumor detection. J Nucl Med 1980; 21: 670-675.
9. Ahmed N, Langlois R, Rodrigue S, et al. Automated synthesis of 11 beta-methoxy-4,16alpha-[16alpha-(18)F]difluoroestradiol (4F-M[(18)F]FES) for estrogen receptor imaging by positron emission tomography. Nucl Med Biol 2007; 34; 459-464.
10. Lee CC, Sui G, Elizarov A, et al. Multistep synthesis of a radiolabeled imaging probe using integrated microfluidics. Science 2005; 310: 1793-1796.
11. Olt SJ, Chi DY, Mosdzianowski C, et al. Fully automated synthesis of [18F]fluoromisonidazole using a conventional [18F]FDG module. Nucl Med Biol 2005; 32: 899-905.
12. Oh SJ, Mosdzianowski C, Chi DY, et al. Fully automated synthesis system of 3′-deoxy-3′-[18F]fluorothymidine. Nucl Med Biol 2004; 31: 803-809.
13. Vuong BK, Kiesewetter DO, Lang L, et al. An automated one-step one-pot [(18)F]FCWAY synthesis: development and minimization of chemical impurities. Nucl Med Biol 2007; 34: 433-438.
14. Berger G, Maziere M, Knipper R, et al. Automated synthesis of 11C-labelled radiopharmaceuticals: imipramine, chlorpromazine, nicotine and methionine. Int J Appl Radiat Isot 1979; 30: 393-399.
15. Comar D, Zarifian E, Verhas M, et al. Brain distribution and kinetics of 11C-chlorpromazine in schizophrenics: positron emission tomography studies. Psychiatry Res 1979; 1: 23-29.
16. Reivich M, Kuhl D, Wolf A, et al. The [18F]fluorodeoxyglucose method for the measurement of local cerebral glucose utilization in man. Circ Res 1979; 44: 127-137.
17. Schelbert HR, Henze E, Phelps ME. Emission tomography of the heart. Semin Nucl Med 1980; 10: 355-373.
18. McCabe W, Smith J, Harriott P. Unit operations of chemical engineering. 5th ed. New York: McGraw-Hill, Inc.; 1993.
19. Brodack JW, Dence CS, Kilbourn MR, et al. Robotic production of 2-deoxy-2-[18F]fluoro-D-glucose: a routine method of synthesis using tetrabutylammonium [18F]fluoride. Int J Rad Appl Instrum [A] 1988; 39: 699-703.
20. Brodack JW, Kilbourn MR, Welch MJ. Automated production of several positron-emitting radiopharmaceuticals using a single laboratory robot. Int J Rad Appl Instrum [A] 1998; 39: 689-698.
21. Moerlein SM, Gaehle GG, Welch MJ. Robotic preparation of Sodium Acetate C 11 Injection for use in clinical PET. Nucl Med Biol 2002; 29: 613-621.
22. Chang CW, Chou TK, Liu RS, et al. A robotic synthesis of [18F]fluoromisonidazole ([18F]FMISO). Appl Radiat Isot 2007; 65: 682-686.
23. Alexoff DL, Russell JA, Shiue CY, et al. Modular automation in PET tracer manufacturing: application of an autosynthesizer to the production of 2-deoxy-2-[18F]fluoro-D-glucose. Int J Rad Appl Instrum [A] 1986; 37: 1045-1061.
24. Crouzel C, Clark JC, Brihaye C, et al. Radiochemisrty Automation for PET. In: Pike GSaVW, editor. Radiopharmaceuticals for Positron Emission Tomography. Netherlands: Kluwer Academic Publishers; 1993. pp. 45-89.
25. Satyamurthy N, Phelps ME, Barrio JR. Electronic Generators for the Production of Positron-Emitter Labeled Radiopharmaceuticals. Where Would PET Be Without Them? din Positron Imaging 1999; 2: 233-253.
26. Padgett HC, Schmidt DG, Luxen A, et al. Computer-controlled radiochemical synthesis: a chemistry process control unit for the automated production of radiochemicals. Int J Rad Appl Instrum [A] 1989; 40: 433-445.
27. Wilson AA, Garcia A, Jin L, et al. Radiotracer synthesis from [(11)C]-iodomethane: a remarkably simple captive solvent method. Nucl Med Biol 2000; 27: 529-532.
28. Roiwainen A, Tolvanen T, Salomaki S, et al. 68Ga-labeled oligonucleotides for in vivo imaging with PET. J Nucl Med 2004; 45: 347-355.
29. Froidevaux S, Eberle AN, Christe M, et al. Neuroendocrine tumor targeting: study of novel gallium-labeled somatostatin radiopeptides in a rat pancreatic tumor model. Int J Cancer 2002; 98: 930-937.
30. Hoffend J, Mier W, Schuhmacher J, et al. Gallium-68-DOTA-albumin as a PET blood-pool marker: experimental evaluation in vivo. Nucl Med Biol 2005; 32: 287-292.
31. Eisenwiener KP, Prata MI, Buschmann I, et al. NODAGATOC, a new chelator-coupled somatostatin analogue labeled with [67/68Ga] and [111In] for SPECT, PET, and targeted therapeutic applications of somatostatin receptor (hsst2) expressing tumors. Bioconjug Chem 2002; 13: 530-541.
32. Wild D, Macke HR, Waser B, et al. 68Ga-DOTANOC: a first compound for PET imaging with high affinity for somatostatin receptor subtypps 2 and 5. Eur J Nucl Med Mol Imaging 2005; 32: 724.
33. Sharma V, Prior JL, Belinsky MG, et al. Characterization of a 67Ga/68Ga radiopharmaceutical for SPECT and PET of MDR P-glycoprotein transport activity in vivo: validation in multidrug-resistant tumors and at the blood-brain barrier. J Nucl Med 2005; 46: 354-364.
34. Cutler CS, Giron MC, Reichert DE, et al. Evaluation of gallium-68 tris(2-mercaptobenzyl)amine: a complex with brain and myocardial uptake. Nucl Med Biol 1499; 26: 305-316.
35. Schuhmacher J, Kaul S, Klivenyi G, et al. Immunoscintigraphy with positron emission tomography: gallium-68 chelate imaging of break cancer pretargeted with bispecific anti-MUC1/anti-Ga chelate antibodies Cancer Res 2001; 61: 3712-3717.
36. Lendvai G, Velikyan I, Bergstrom M, et al. Biodistribution of 68Ga-labelled phosphodiester, phosphorothloate, and 2′-O-methyl phosphodiester oliganucleotides in normal rats. Eur J Pharm Sci 2005; 26: 26-38.
37. Velikyan I, Sundberg AL, Lindhe O, et al. Preparation and evaluation of (68)Ga-DOTA-hEGF for visualization of EGFR expression in malignant tumors. J Nucl Med 2005; 46: 1881-1888.
38. Ito M, Yang DJ, Mawlawi O, et al. PET and planar imaging of tumor hypoxia with labeled metronidazole. Acad Radiol 2006; 13: 598-609.
39. Yang DJ, Ozaki K, Oh CS, et al. (99m)Tc-EC-guanine: synthesis, biodistribution, and tumor imaging in amimals. Pharm Res 2005; 22: 1471-1479.
40. Schechter NR, Wendt RE, 3rd, Yang DJ, et al. Radiation dosimetry of 99mTc-labeled C225 in patients with squamous cell carcinoma of the head and neck. J Nucl Med 2004; 45: 1683-1687.
41. Yang D, Yukihiro M, Yu DF, et al. Assessment of therapeutic tumor response using 99mtc-ethylenedicysteine-glucosamine. Cancer Biother Radiopharm 2004; 19: 443-456.
42. Yang DJ, Azhdarinia A, Wu P, et al. In vivo and in vitro measurement of apoptosis in breast cancer cells using 99mTc-EC-annexin V. Cancer Biother Radiopharm 2001; 16: 73-83.
43. Yang DJ, Bryant J, Chang JY, et al. Assessment of cyclooxygense-2 expression with 99mTc-labeled celebrex. Anticancer Drugs 2004; 15: 255-263.
44. Yang DJ, Ilgan S, Hauchi T, et al. Noninvasive assessment of tumor hypoxia with 99mTc labeled metronidazole. Pharm Res 1999; 16: 743-750.
45. Schechter NR, Yang DJ, Azhdarinia A, et al. Assessment of epidermal growth factor receptor with 99mTc-ethylenedicysteine-C225 monoclonal antibody. Anticancer Drugs 2003; 14: 49-56.
46. Azhdarinia A, Yang DJ, Chao C, et al. Infrared-based module for the synthesis of 68Ga-labeled radiotracers. Nucl Med Biol 2001; 34: 121-127.
47. Meyer GJ, Macke H, Schuhmacher J, et al. 68Ga-labelled DOTA-derivatised peptide ligands. Eur J Nucl Med Mol Imaging 2004; 31: 1097-1104.
48. Velikyan I, Beyer GJ, Langstrom B. Microwave-supported preparation of (68)Ga bioconjugates with high specific radioactivity. Bioconjug Chem 2004; 15: 554-560.
49. Decristoforo C, Knopp R, von Guggenberg E, et al. A fully automated synthesis for the preparation of 68Ga-labelled peptides. Nucl Med Commun 2007; 28.