-
Je něco špatně v tomto záznamu ?
Automated Production of [68Ga]Ga-Desferrioxamine B on Two Different Synthesis Platforms
M. Kraihammer, M. Petřík, C. Rangger, M. Gabriel, H. Haas, B. Nilica, I. Virgolini, C. Decristoforo
Status neindexováno Jazyk angličtina Země Švýcarsko
Typ dokumentu časopisecké články
Grantová podpora
DOI: 10.55776/KLI909
FWF Austrian Science Fund
NLK
Directory of Open Access Journals
od 2010
Free Medical Journals
od 2010
PubMed Central
od 2009
Europe PubMed Central
od 2009
ProQuest Central
od 2009-01-01
Open Access Digital Library
od 2009-01-01
Open Access Digital Library
od 2010-01-01
ROAD: Directory of Open Access Scholarly Resources
od 2009
- Publikační typ
- časopisecké články MeSH
Background/Objectives: PET imaging of bacterial infection could potentially provide added benefits for patient care through non-invasive means. [68Ga]Ga-desferrioxamine B-a radiolabelled siderophore-shows specific uptake by human-pathogenic bacteria like Staphylococcus aureus or Pseudomonas aeruginosa and sufficient serum stability for clinical application. In this report, we present data for automated production of [68Ga]Ga-desferrioxamine B on two different cassette-based synthesis modules (Modular-Lab PharmTracer and GRP 3V) utilising commercially obtainable cassettes together with a licensed 68Ge/68Ga radionuclide generator. Methods: Quality control, including the determination of radiochemical purity, as well as a system suitability test, was set up via RP-HPLC on a C18 column. The two described production processes use an acetic acid/acetate buffer system with ascorbic acid as a radical scavenger for radiolabelling, yielding ready-to-use formulations with sufficient activity yield. Results: Batch data analysis demonstrated radiochemical purity of >95% by RP-HPLC combined with ITLC and excellent stability up to 2 h after synthesis. Specifications for routine production were set up and validated with four masterbatches for each synthesis module. Conclusions: Based on this study, an academic clinical trial for imaging of bacterial infection was initiated. Both described synthesis methods enable automated production of [68Ga]Ga-desferrioxamine B in-house with high reproducibility for clinical application.
Department of Nuclear Medicine Medical University Innsbruck Anichstrasse 35 A 6020 Innsbruck Austria
Institute of Molecular Biology Biocenter Medical University of Innsbruck A 6020 Innsbruck Austria
Medical Faculty Johannes Kepler University Linz Altenberger Strasse 69 A 4040 Linz Austria
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc24017774
- 003
- CZ-PrNML
- 005
- 20241016081917.0
- 007
- ta
- 008
- 241008s2024 sz f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.3390/pharmaceutics16091231 $2 doi
- 035 __
- $a (PubMed)39339267
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a sz
- 100 1_
- $a Kraihammer, Martin $u Department of Nuclear Medicine, Medical University Innsbruck, Anichstrasse 35, A-6020 Innsbruck, Austria $u Institute of Nuclear Medicine and Endocrinology, Kepler University Hospital, Krankenhausstrasse 9, A-4021 Linz, Austria $u Medical Faculty, Johannes Kepler University Linz, Altenberger Strasse 69, A-4040 Linz, Austria $1 https://orcid.org/0009000584671841
- 245 10
- $a Automated Production of [68Ga]Ga-Desferrioxamine B on Two Different Synthesis Platforms / $c M. Kraihammer, M. Petřík, C. Rangger, M. Gabriel, H. Haas, B. Nilica, I. Virgolini, C. Decristoforo
- 520 9_
- $a Background/Objectives: PET imaging of bacterial infection could potentially provide added benefits for patient care through non-invasive means. [68Ga]Ga-desferrioxamine B-a radiolabelled siderophore-shows specific uptake by human-pathogenic bacteria like Staphylococcus aureus or Pseudomonas aeruginosa and sufficient serum stability for clinical application. In this report, we present data for automated production of [68Ga]Ga-desferrioxamine B on two different cassette-based synthesis modules (Modular-Lab PharmTracer and GRP 3V) utilising commercially obtainable cassettes together with a licensed 68Ge/68Ga radionuclide generator. Methods: Quality control, including the determination of radiochemical purity, as well as a system suitability test, was set up via RP-HPLC on a C18 column. The two described production processes use an acetic acid/acetate buffer system with ascorbic acid as a radical scavenger for radiolabelling, yielding ready-to-use formulations with sufficient activity yield. Results: Batch data analysis demonstrated radiochemical purity of >95% by RP-HPLC combined with ITLC and excellent stability up to 2 h after synthesis. Specifications for routine production were set up and validated with four masterbatches for each synthesis module. Conclusions: Based on this study, an academic clinical trial for imaging of bacterial infection was initiated. Both described synthesis methods enable automated production of [68Ga]Ga-desferrioxamine B in-house with high reproducibility for clinical application.
- 590 __
- $a NEINDEXOVÁNO
- 655 _2
- $a časopisecké články $7 D016428
- 700 1_
- $a Petřík, Miloš $u Institute of Molecular and Translational Medicine, Faculty of Medicine and Dentistry, Palacky University, CZ-77900 Olomouc, Czech Republic $1 https://orcid.org/0000000313345916
- 700 1_
- $a Rangger, Christine $u Department of Nuclear Medicine, Medical University Innsbruck, Anichstrasse 35, A-6020 Innsbruck, Austria $1 https://orcid.org/0000000311679779
- 700 1_
- $a Gabriel, Michael $u Institute of Nuclear Medicine and Endocrinology, Kepler University Hospital, Krankenhausstrasse 9, A-4021 Linz, Austria $u Medical Faculty, Johannes Kepler University Linz, Altenberger Strasse 69, A-4040 Linz, Austria
- 700 1_
- $a Haas, Hubertus $u Institute of Molecular Biology, Biocenter, Medical University of Innsbruck, A-6020 Innsbruck, Austria $1 https://orcid.org/0000000324729878
- 700 1_
- $a Nilica, Bernhard $u Department of Nuclear Medicine, Medical University Innsbruck, Anichstrasse 35, A-6020 Innsbruck, Austria
- 700 1_
- $a Virgolini, Irene $u Department of Nuclear Medicine, Medical University Innsbruck, Anichstrasse 35, A-6020 Innsbruck, Austria $1 https://orcid.org/0000000170976170
- 700 1_
- $a Decristoforo, Clemens $u Department of Nuclear Medicine, Medical University Innsbruck, Anichstrasse 35, A-6020 Innsbruck, Austria $1 https://orcid.org/0000000305664036
- 773 0_
- $w MED00186380 $t Pharmaceutics $x 1999-4923 $g Roč. 16, č. 9 (2024)
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/39339267 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20241008 $b ABA008
- 991 __
- $a 20241016081912 $b ABA008
- 999 __
- $a ok $b bmc $g 2196371 $s 1229725
- BAS __
- $a 3
- BAS __
- $a PreBMC-PubMed-not-MEDLINE
- BMC __
- $a 2024 $b 16 $c 9 $e 20240921 $i 1999-4923 $m Pharmaceutics $n Pharmaceutics $x MED00186380
- GRA __
- $a DOI: 10.55776/KLI909 $p FWF Austrian Science Fund
- LZP __
- $a Pubmed-20241008