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Catalogue ABX Advancend Biochemical Compounds ABX advanced biochemical compounds Chemicals for Molecular Imaging 2017 ABX advanced biochemical compounds Manufacturing and development of chemicals for molecular imaging • Worldwide leading supplier of PET precursors and FDG reagents kits • Production and development of PET and SPECT precursors and reference standards • Manufacturing of reagents kits and cassettes, particularly kits for FDG, F-DOPA, FLT, F-Choline, NaF, F- MISO, FES and FET production • US (FDA) and European Drug Master File (DMF) for Mannose Triflate (FDG precursor) • European Drug Master File (DMF) for FDG reagents kits using the GE TRACERlab MX, Neptis and Siemens Explora One synthesis modules • Further DMFs and technical documents for PET and SPECT precursors • Custom synthesis and manufacturing according to GMP for APIs • Design, custom synthesis and production of peptides (GMP quality on request) • Leading manufacturer of reagents kits and cassettes for 68Ga -Labelling • Performance of stability studies • Hot Lab for R&D of new pharmaceutical kits and cassettes and co-operation with pharmaceutical companies • Development of radiotracers as well as labelling and purification strategies • Distributor of 18O-Water FDG grade and GMP grade • ROVER - ABX PET evaluation software • 17 years experience • 190 professionals (among them 20 with PhD) • New manufacturing, filling and assembling sites • Clean room facilities for the production and filling under pharmaceutical conditions • Audited and accepted as GMP API manufacturer by: - German pharmaceutical authorities - FDA (US Food and Drug Administration) ABX advanced biochemical compounds History of ABX 1997: - foundation of ABX GmbH - vision: production of PET precursor – Diprenorphine 1998: - start with own laboratory ( 30 sqm) - start with CRO business 2001: - start of kit production in new facilities in Robert-Bosch-Strasse 2002: - split off of CRO business into independant ABX-CRO GmbH - purchase of facilities in Heinrich-Glaeser-Strasse 10 – 14 and start of reconstruction 2003: - chemical labs and clean rooms in Heinrich-Glaeser-Strasse 12 operational 2004: - successful audit by “Regierungspraesidium Dresden” for GMP production 2005: - successful audit by FDA for GMP compliance for APIs - successful audit by “Regierungspraesidium Dresden” for license of wholesalers 2006: - change in ownership – new owner: CIL / Cambridge Isotope Laboratories, Inc. (USA), subsidiary of Otsuka Pharmaceuticals (Japan) 2007: - hot (radiosynthesis) laboratory for R&D in Heinrich-Glaeser-Strasse 10 operational - re-audit by “Regierungspraesidium Dresden” for GMP-production 2008: - re-audit by FDA for GMP compliance for APIs 2011: - re-audit by “Landesdirektion Dresden” for GMP production 2012: - re-audit by FDA for GMP compliance for APIs 2013: - new production building for GMP filling and assembling in Heinrich-Glaeser-Strasse 14 operational 2013: - re-audit by “Landesdirektion Dresden” for the new ABX GMP facility 2015: - new cyclotron facility including additional radiochemistry lab operational ABX advanced biochemical compounds FDG Mannose Triflate (TATM) - Globally, ABX is the biggest producer of Mannose Triflate - continuous production, with a constant stock of minimum 5 kgs - documentation in Drug Master Files (US-DMF and ASMF) in accordance with regulations of the International Conference of Harmonization (ICH) – submitted to the national authorities of: USA (FDA) Germany Austria Belgium Czech Republic Denmark Finland France Greece Hungary Ireland Israel Italy Luxembourg Portugal Singapore Slovakia Spain Sweden Switzerland The Netherlands United Kingdom - validated production process - detailed stability testing in accordance with ICH regulations - fully automated filling under argon atmosphere with a controlled pharmaceutical background FDG Reagents Kits Our kits contain all chemicals needed for the FDG synthesis in the modules of: • GE TRACERlab MXFDG – recommended by GE (ASMF available in Denmark, France, Spain, Sweden) • GE TRACERlab FXF-N or FXFDG – recommended by GE • IBA Synthera • SIEMENS Explora FDG4 • SIEMENS Explora One – recommended by SIEMENS • ORA NEPTIS perform and plug – recommended by ORA • ORA NEPTIS mosaic-LC and mosaic-RS – recommended by ORA • SCINTOMICS – recommended by SCINTOMICS • Eckert & Ziegler (former Bioscan) FDG-Plus • SYNTHRA FDGtwo and Rnplus – recommended by SYNTHRA All our kits can be delivered as chemical grade as well as pharmaceutical grade quality (with specified analytical limits and tested for microbiological contamination). ABX advanced biochemical compounds Cryptand 222 We also manufacture Cryptand 222 for the production of FDG - high quality Cryptand 18 - special analytical procedures meet the demands of [ F]FDG synthesis Cassettes We produce cassettes and tubing systems for several of the existing FDG modules NEW: We have developed a high-yield cassette, ABX product no. K-1401TM, for the ORA NEPTIS and the SIEMENS Explora One module, that can be used alternating for all GE TRACERlab MX and COINCIDENCE boxes. Cartridges - GE TRACERlab MXFDG - pre-conditioned QMA cartridge - GE TRACERlab FXFDG or FXF-N and SYNTHRA FDGtwo and Rnplus 18 - GE F Separation cartridge (Chromafix PS-HCO3) - GE FDG Purification cartridge (Chromabond Set IV and V) Evacuated Vials in different sizes We manufacture evacuated vials for the use in the GE TRACERlab MX and FX module as well as evacuated and/or sterile vials for any other needs. Accessories/Ancillaries In addition we offer further cartridges and vials, syringes, needles, filters and so on for as example the GE TRACERlab MX, the IBA Synthera, the SIEMENS Explora and other FDG modules STOCK in the US ABX keeps a stock of Mannose Triflate, Cryptand 222 and Kits for the GE TRACERlab MX and FX module in South Bend, Indiana. We can deliver to every place in the US within 24 hours (overnight shipment) in case you inform us in the morning. Otherwise shipments may take up to 48 hours. Please note that research chemicals and other products can only be shipped from our stock in Germany. US phone no.: (574) 271-3521 ABX advanced biochemical compounds PET and SPECT Precursors - PET precursors for FDG F-DOPA FLT FET F-Choline F-MISO FAZA FES FHBG Fallypride MPPF Altanserin FDHT Flumazenil Diprenorphine PIB Methionine Raclopride DASB PK 11195 beta-CIT PE2I Altropane FLB 457 PBR28 Verapamil DTBZ MHED MDL 100907 ABP688 ATSM etc. - Reference standards - Peptides - DKFZ-PSMA-11 (GMP and research grade) - DKFZ-PSMA-617 (GMP and research grade) - DOTA-TATE (GMP) - DOTA-NOC (GMP and research grade) etc. - SPECT precursors for - MIBG (GMP and research grade) - FIAU etc. - Chelators for radionuclides - CuMibi (GMP and research grade) - Mebrofenin - Hynic - EC/ECD etc. Certificate of Analysis as well as NMR spectrum and/or HPLC included. ABX advanced biochemical compounds Reagents Kits FDG reagents kits: • GE TRACERlab MXFDG – recommended by GE (ASMF available in Denmark, France, Spain, Sweden) • GE TRACERlab FXF-N or FXFDG – recommended by GE • IBA Synthera • SIEMENS Explora FDG4 • SIEMENS Explora One – recommended by SIEMENS • ORA NEPTIS perform and plug – recommended by ORA • ORA NEPTIS mosaic-LC and mosaic-RS – recommended by ORA • SCINTOMICS GRP – recommended by SCINTOMICS • Eckert & Ziegler (former Bioscan) FDG-Plus • SYNTHRA FDGtwo and Rnplus – recommended by SYNTHRA • Others on request Complete solutions for additional 18F and 68Ga tracer productions: • F-DOPA, FLT, F-Choline, NaF, F-MISO, FES, FET, FHBG, SFB, F-acetate, and FDGal reagents kits designed for the GE TRACERlab MX, the ORA NEPTIS perform, plug and mosaic-RS as well as the SIEMENS Explora One synthesis modules including cassette, accessories & cartridges, manual and software (sequences) • F-DOPA, FLT, FET, F-MISO, F-Choline, FES and 11C-chemistry reagents kits designed for the GE TRACERlab FX box • FLT, NaF, F-Choline and F-DOPA reagents kits designed for the IBA Synthera box including cassette (IFP) and ancillaries • FLT, NaF, F-Choline, FET and F-MISO reagents kits as well as general 68Ga labelling, 90Y and 177Lu reagents kits designed for the SCINTOMICS GRP module including cassettes ABX advanced biochemical compounds • FLT and F-MISO reagents kits designed for the Eckert & Ziegler (former Bioscan) FDG-Plus box • 68Ga reagents kits (two cationic versions) designed for the Eckert & Ziegler Modular-Lab systems – supplied by Eckert & Ziegler • 68Ga reagents kits and cassettes designed for the ITG iQS 68Ga Fluidic Labeling Module – supplied by ITG • F-DOPA cassettes filled with all reagents for the GE FASTlab Synthesizer – supplied by GE Certificates of Analysis always included. We are always interested in the development of new reagents kits and cassettes systems for YOUR 18F and 68Ga tracers – development according to you requests. We are well experienced in that field and do have an own radiochemistry lab with several hot cells; nearly all common synthesis modules are installed. Also, we could offer the development of an appropriate quality control procedure. If you should be interested in that type of service or would like to learn much more about the possbilities we could offer, please contact us at [email protected]. ABX advanced biochemical compounds Custom Synthesis ABX offers the following services: • Custom synthesis in quantities from milligrams to kilograms, development, and production of: PET precursors and reference standards SPECT precursors Neurochemicals Metabolites • Synthesis of Peptides from 5 to 40 amino acids (quantities up to 10 grams) special modifications including: D-amino
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