Article
Biochemistry & Molecular Biology
Monika Skulska, Lise Falborg
Summary: The purpose of this study was to develop a GMP-compliant, easy kit-based synthesis of [Ga-68]Ga-EDTA for human use. The production and labeling of the cold kit were validated, along with the measurement of radiochemical purity and Na(2)EDTA dihydrate content in the kits. The study successfully validated a GMP kit for the simple production of [Ga-68]Ga-EDTA, with the intention of human use.
Article
Biochemical Research Methods
Jillissa C. Taubel, Nicholas R. Nelson, Aditya Bansal, Geoffrey L. Curran, Lushan Wang, Zengtao Wang, Heather M. Berg, Cynthia J. Vernon, Hoon-Ki Min, Nicholas B. Larson, Timothy R. DeGrado, Karunya K. Kandimalla, Val J. Lowe, Mukesh K. Pandey
Summary: Aberrant insulin signaling has been identified as a risk factor for Alzheimer's disease. A new positron emission tomography (PET) probe has been developed to study the role of insulin in Alzheimer's disease noninvasively. The PET probe showed higher uptake in the brains of Alzheimer's disease mice compared to normal mice. It also demonstrated differential uptake in different brain regions.
BIOCONJUGATE CHEMISTRY
(2022)
Article
Chemistry, Medicinal
Elisabeth Plhak, Christopher Pichler, Bjorn Dittmann-Schnabel, Edith Gossnitzer, Reingard M. Aigner, Susanne Stanzel, Herbert Kvaternik
Summary: A newly programmed automatic synthesis process of [Ga-68]Ga-FAPI-46 was successfully developed, using two Galli Ad generators as a radionuclide source and a Scintomics GRP module for automation. The compound was purified by solid-phase extraction and strong cation exchange, resulting in a high radiochemical yield and purity. The final product met the quality criteria set by the European Pharmacopoeia.
Article
Chemistry, Inorganic & Nuclear
Jannie le Roux, Sietske Rubow, Thomas Ebenhan
Summary: This study compared the labelling characteristics of manual and automated synthesis methods for Gallium-68 labelled NOTA-UBI, finding that automated synthesis provides higher robustness and repeatability while reducing radiation exposure to operators. It also suggests the consideration of radical scavengers to reduce radiolysis in automated synthesis.
APPLIED RADIATION AND ISOTOPES
(2021)
Article
Chemistry, Analytical
Yang Liu, Li Xia, Ping Cai, Yingwen Wang, Yue Feng, Wei Zhang, Nan Liu, Yue Chen, Zhijun Zhou
Summary: This study synthesizes new PSMA-targeted radiotracers and finds that these three compounds can visualize PSMA-positive LNCaP tumors as early as 5 min post-injection. All three compounds have high affinity for the tumor. Among them, [Ga-68]SC691-HBEDCC shows the highest uptake and retention in the tumor over 2 h post-injection and a lower tumor-to-tissue ratio compared to [Ga-68]SC691-DOTA and [Ga-68]SC691-NOTA.
JOURNAL OF RADIOANALYTICAL AND NUCLEAR CHEMISTRY
(2023)
Review
Biochemistry & Molecular Biology
Michaela Oeller, Sandra Laner-Plamberger, Linda Krisch, Eva Rohde, Dirk Strunk, Katharina Schallmoser
Summary: HPL serves as a valuable alternative to fetal bovine serum in cell culture, allowing for efficient and animal serum-free cell propagation. Providers must adhere to strict quality control and regulatory requirements to ensure safe and GMP-compliant production of HPL. The starting material for HPL preparation is fresh or expired platelet concentrates from healthy donors, and the process may involve pathogen reduction technologies.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2021)
Article
Oncology
P. K. J. D. de Jonge, P. M. M. van Hauten, L. D. Janssen, A. L. de Goede, M. M. Berrien-Elliott, J. M. R. van der Meer, C. M. Mousset, M. W. H. Roeven, M. Foster, N. Blijlevens, W. Hobo, T. A. Fehniger, J. H. Jansen, N. P. M. Schaap, H. Dolstra
Summary: Allogeneic natural killer (NK) cell-based immunotherapy is a promising approach for acute myeloid leukemia (AML). A good manufacturing practice (GMP)-compliant, cytokine-based ex vivo manufacturing process for generating NK cells from CD34(+) hematopoietic stem and progenitor cells (HSPC) has been developed. This process generates a consistent and active NK cell product that meets the requirements for NK cell immunotherapy. The manufactured NK cell batches are used in a clinical trial approved by the Dutch Ethics Committee.
CANCER IMMUNOLOGY IMMUNOTHERAPY
(2023)
Article
Cardiac & Cardiovascular Systems
Zohreh Varasteh, Miriam Braeuer, Sarajo Mohanta, Anna-Lena Steinsiek, Andreas Habenicht, Negar Omidvari, Geoffrey J. Topping, Christoph Rischpler, Wolfgang A. Weber, Hendrik B. Sager, Geert Raes, Sophie Hernot, Markus Schwaiger
Summary: This study evaluated the feasibility of using Ga-68-NOTA-anti-MMR Nb for imaging MR on alternatively activated macrophages in murine MI models. The results showed that this imaging method can specifically identify MR-positive macrophages, providing insights into the wound healing process post-MI.
FRONTIERS IN CARDIOVASCULAR MEDICINE
(2022)
Article
Radiology, Nuclear Medicine & Medical Imaging
Ankit Watts, Surbhi Chutani, Diksha Arora, Vasanth Madivanane, Samiksha Thakur, Monika Kamboj, Baljinder Singh
Summary: This study successfully optimized the automated radiosynthesis of Ga-68 Pentixafor and conducted extensive quality control tests. The biodistribution study in a healthy volunteer showed good in vivo stability of the tracer, indicating its excellent clinical applicability.
INDIAN JOURNAL OF NUCLEAR MEDICINE
(2021)
Article
Radiology, Nuclear Medicine & Medical Imaging
Martin Kraihammer, Elisabeth von Guggenberg, Anton Amadeus Hoermann, Michael Gabriel, Clemens Decristoforo
Summary: This study presents an automated method for the production of [Ga-68]Ga-DOTA-exendin-4, ensuring high reproducibility and low radiation burden. The produced product showed high radiochemical purity and good stability. This method can be used for routine clinical application.
NUCLEAR MEDICINE AND BIOLOGY
(2023)
Article
Multidisciplinary Sciences
Jerome Montnach, Maxime Lorenzini, Adrien Lesage, Isabelle Simon, Sebastien Nicolas, Eleonore Moreau, Celine Marionneau, Isabelle Baro, Michel De Waard, Gildas Loussouarn
Summary: The whole-cell voltage-clamp technique requires consideration of the impact of current amplitude on data accuracy, especially in high throughput patch-clamp applications to prevent inaccuracies. Mathematical kinetic models can predict how large current amplitudes and series resistance artifacts affect voltage-dependent activation and inactivation processes, providing simple guidelines for practice.
SCIENTIFIC REPORTS
(2021)
Article
Cell & Tissue Engineering
Alan F. Zahorchak, Misty L. DeRiggi, Jennifer L. Muzzio, Veronica Sutherland, Abhinav Humar, Fadi G. Lakkis, Yen-Michael S. Hsu, Angus W. Thomson
Summary: Regulatory dendritic cells (DCregs) have potential as a cell therapy for immune-mediated disorders. This study generated and validated large numbers of DCregs for infusion into liver transplant recipients. The DCregs met quality criteria and achieved target cell numbers, offering a promising approach to improve patient outcomes.
Article
Biochemistry & Molecular Biology
Stefano Canosa, Katia Mareschi, Elena Marini, Andrea Roberto Carosso, Sara Castiglia, Deborah Rustichelli, Ivana Ferrero, Gianluca Gennarelli, Benedetta Bussolati, Alberto Nocifora, Valentina Asnaghi, Massimiliano Bergallo, Ciro Isidoro, Chiara Benedetto, Alberto Revelli, Franca Fagioli
Summary: The study compared two different endometrial sampling methods and validated a novel xeno-free method for culturing human E-MSCs. Results showed that VABRA endometrial sampling could be an alternative to surgical curettage, providing efficient isolation and culture of E-MSCs in Good Manufacturing Practice compliance conditions.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2022)
Article
Engineering, Chemical
Axel Schmidt, Heribert Helgers, Florian Lukas Vetter, Alex Juckers, Jochen Strube
Summary: The study highlights the bottleneck in manufacturing COVID-19 vaccines for the global population and suggests using digital twins and process analytical technology to enhance production efficiency. Transitioning to semi-continuous stainless-steel technology is recommended to reduce plant commissioning and start-up times, increase vaccine output, and lower operating costs.
Article
Biochemistry & Molecular Biology
Katia Mareschi, Alessia Giovanna Santa Banche Niclot, Elena Marini, Elia Bari, Luciana Labanca, Graziella Lucania, Ivana Ferrero, Sara Perteghella, Maria Luisa Torre, Franca Fagioli
Summary: This study modified the type of culture supplement used in the production of freeze-dried mesenchymal stem cell (MSC)-secretome (lyo-secretome), and found that changing the supplement type only resulted in minimal changes in product composition without affecting potency, validating the new process according to GMP standards.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2022)
Article
Chemistry, Inorganic & Nuclear
Jannie le Roux, Sietske Rubow, Thomas Ebenhan
Summary: This study compared the labelling characteristics of manual and automated synthesis methods for Gallium-68 labelled NOTA-UBI, finding that automated synthesis provides higher robustness and repeatability while reducing radiation exposure to operators. It also suggests the consideration of radical scavengers to reduce radiolysis in automated synthesis.
APPLIED RADIATION AND ISOTOPES
(2021)
Article
Biochemical Research Methods
Janke Kleynhans, Sietske Rubow, Jannie le Roux, Biljana Marjanovic-Painter, Jan Rijn Zeevaart, Thomas Ebenhan
JOURNAL OF LABELLED COMPOUNDS & RADIOPHARMACEUTICALS
(2020)
Letter
Chemistry, Medicinal
Jannie le Roux, Janke Kleynhans, Sietske Rubow
Summary: HEPES is a buffer used in the radiolabelling of gallium-68 compounds, with beneficial effects on molar activity in bioconjugates. However, strict regulations on its content in radiopharmaceuticals limit its use for parenteral administration. This communication summarizes data on HEPES toxicity in dogs and subsequent human use, as well as highlighting its use in an FDA labelled intravenous drug formulation that regulatory institutions may consider for review of current limits.
EJNMMI RADIOPHARMACY AND CHEMISTRY
(2021)
